Mostrando las entradas para la consulta cbd ordenadas por fecha. Ordenar por relevancia Mostrar todas las entradas
Mostrando las entradas para la consulta cbd ordenadas por fecha. Ordenar por relevancia Mostrar todas las entradas

domingo, 26 de mayo de 2024

Citario : Pan, iris y CBD / Isabel Coixet

 

 

"El tercer misterio es la proliferación de tiendas de CBD, (el cannabis sin de tiendarahidrocannabinol), que es la parte psicoactiva de la marihuana (para entendernos, la que coloca): no hay barrio que se precie que no tenga dos o doscientas. En crema, aceite, capsulas, píldoras, gominolas, espray o cargadores para vapear, el CBD parece la panacea para todos los males, físicos y mentales. Igual yo debo de poseer algún gen raro o ser inmune al CBD, porque confieso que, habiendo probado todas esas cosas, con más o menos intensidades, no he sentido ni tan siquiera un ligero alivio. 


Me pregunto si estos negocios, las panaderías chachis, las tiendas de fotografías de iris y los negocios de CBD, tienen futuro o irán a compartir limbo con los lugares donde mataban a los piojos o enseñaban a hacer macramé." 

Isabel Coixet

Ver también...:

 Todo sobre CBD en PHARMACOSERIAS

 

 

jueves, 2 de febrero de 2023

FDA: Evalua decisiones sobre "legal cannabis & CBD"


 As cannabis becomes legalized in an increasing number of states – New York State is set to open its first legal recreational marijuana dispensary Thursday – the Food and Drug Administration is weighing how it will regulate the substance as well as cannabis-derived CBD.

Ver:

First licensed retail cannabis dispensary opens in NY

The agency plans to make recommendations on how to regulate CBD, or cannabidiol, in food and supplements in the coming months.


While CBD doesn’t cause the “high” that tetrahydrocannabinol, or THC, does, products containing it are still not technically FDA-approved, aside from Epidiolex, a CBD treatment for rare seizure disorders.

Ver:

Todo sobre Epidiolex en PHARMACOSERÍAS

In 2018, Congress removed hemp (and thus hemp-derived CBD) from the federal Controlled Substances Act, leaving it to states to decide whether to allow the sale of CBD products.

As of now, the FDA has dictated that CBD can’t be added to foods or marketed as supplements, and companies must provide evidence from clinical trials if they claim their CBD products are therapeutic. Aside from that, however, companies selling CBD products haven’t had specific federal rules on how to market their products.

The agency is thus preparing to develop clearer ones after investigating whether CBD can be considered a food or supplement as opposed to simply a drug.

In an interview with The Wall Street Journal this week, FDA principal deputy commissioner Janet Woodcock, MD noted that CBD “raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance.”

In particular, the FDA wants to examine whether CBD can be ingested every day and over long-term periods safely, and whether it’s safe during pregnancy. They’re also aiming to better educate consumers on the wide variety of CBD products that are already out there – all of which have different levels of quality and safety.

“The safety profiles around these products are not what they are generally accustomed to and not the same as what they get from other products when they walk into a wellness store or grocery store or even a gas station,” Norman Birenbaum, a senior adviser at the FDA, told The Wall Street Journal.

Still, the CBD and cannabis-derived products industry has expanded in recent years, expected to grow from a $4.6 billion market in 2021 to nearly four times that by 2026.

The National Cannabis Industry Association, a trade group for cannabis businesses, has argued that any federal guidelines should fall into place with current state guidelines that allow the sale of CBD.

“The states are decades ahead of the federal government,” Aaron Smith, CEO of the trade group, told The Wall Street Journal. Medical marketers, meanwhile, have long jumped on the opportunity to begin exploring how to market legal cannabis brands as more states allow the sale of it.

jueves, 14 de abril de 2022

Para_Pharma_Lia; CBD supositorios


DO CANNABIS SUPPOSITORIES WORK? 

The low-down on what’s up with rectal and vaginal delivery.

The back door is making a comeback - medically speaking.

Cannabis suppositories have grown in popularity, but how and to what extent they actually work remains a mystery. With contradictory claims from proponents and skeptics regarding the rectal bioavailability of THC, intoxication (or lack thereof), and alleviation of symptoms of difficult-to-treat diseases, it’s time to get a grip on what we really know about this method of administering cannabis.

Clinical research on cannabis suppositories is still limited. Much of the available data pertains to experiments conducted on animals, not on people who actually use suppositories. Despite the distinct lack of clinical studies, anecdotal accounts from patients are often very positive. The overwhelming majority of patient reports have one thing in common: a lack of intoxication that’s typically caused by smoking or ingesting THC-rich cannabis.

The absence of a “head high” would seem to indicate that a suppository does not distribute a systemic dose of cannabis – which corroborates initial research findings about limited bioavailability. This suggests that a suppository acts more like a topical with a local effect, rather than a transdermal patch which disseminates medicine systemically through the bloodstream.

WHY SUPPOSITORIES?

Rectal and vaginal suppositories have both been used to deliver medicine to patients for decades. The pelvic region houses a matrix of nerves that travel to the legs and up the spine, and the colon contains cannabinoid receptors (CB1 and CB2), which mediate many of THC’s effects.

Generally, cannabis suppositories are made by combining cannabis-infused oils in a carrier oil that hardens at low temperatures. Rectal administration of cannabis oil may activate the cannabinoid receptors located there, which could be beneficial for local conditions like hemorrhoids or acute inflammation. The rectum also contains a number of key veins that deliver blood to the entire body, but it doesn’t appear that suppositories facilitate cannabinoid absorption into the bloodstream.

Even if they are only effective locally rather than systemically, suppositories may offer a viable alternative to patients suffering from conditions that render them unable to ingest their prescriptions orally. Issues with palatability, severe nausea or vomiting, compromised esophageal or gastrointestinal tracts, and a range of other symptoms can make oral administration an impossibility for many patients.


CLINICAL RESEARCH

A number of studies have called into question the rectal bioavailability of THC. In a 1985 study, researchers found no circulating levels of Δ9 THC in blood plasma after rectal administration of THC. According to University of Mississippi pharmacologist and researcher Dr. Mahmoud ElSohly, this means that in commercially available formulations THC is not absorbed into the bloodstream via the rectum at all.

ElSohly claims that any cerebral intoxication experienced using cannabis suppositories is a result of the placebo effect rather than the activation of the CB1 cannabinoid receptors in the brain – which is what makes us feel high from THC.

Interestingly, a later study showed that a chemically modified version of THC, called THC-hemisuccinate (or THC-HS for short), is bioavailable in the rectum. Succinate, an intermediate compound in the breakdown of sugar, is slightly water soluble, which allows it to be absorbed through the rectal mucosa. It was first synthesized at ElSohly Laboratories, Inc. 

Unlike regular THC, THC from the hemisuccinate ester was found to easily permeate and absorb into rectal mucus membranes, then enter into circulation as Δ9 THC. As a result, most of the THC avoided first-pass metabolism and did not transform into its more psychotropically potent metabolite, 11-hydroxy-THC, in the liver.

The results from a follow-up 1996 pilot study support the idea that THC-HS administered rectally could result in improvement in symptoms of spasticity, rigidity, and pain, while producing no measurable differences in cardiovascular function, concentration, and mood of the participants – in other words, without signs of measurable intoxication.


Most recently, in 2018, ElSohly and his team found that the concentration of Δ9 THC in blood plasma after rectal administration of a THC-HS suppository was about 70-80% bioavailable, almost 2.5 times higher than an orally ingested THC capsule. While there were no reports of intoxication for the test subjects, the paper states that first-pass metabolism was “greatly reduced,” although not eliminated entirely. This means that some slight psychotropic effects from the 11-hydroxy-THC could still be possible with THC-HS formulation, but more studies are necessary to confirm this.

ElSohly’s research could have significant implications for cancer patients and others suffering from conditions that may require very high doses of cannabinoids but who are unable to smoke or ingest their medicine. THC-HS, however, is a patented molecule and can only be prepared with a license from the University of Mississippi.

.../...

WHO CAN BENEFIT?

Whether or not cannabinoids are absorbed into the bloodstream from the rectum, many suppository enthusiasts report powerful, localized, non-psychotropic effects for a range of middle and lower body afflictions.

VAGINAL SUPPOSITORIES

Vaginal suppositories have been used to ease menstrual cramps, abdominal pain, endometriosis, pelvic discomfort, post-coital pain or inflammation, vaginal dryness and pain with intercourse, as well as for relaxation and sexual enhancement.

Of course, dosing via the vagina or rectum is not as simple as taking a puff or swallowing a pill (lest we forget about gravity). Cannabinoids are tricky molecules and there’s still much to learn scientifically and pragmatically about the efficacy of various delivery systems, including cannabis suppositories.

Thus far, clinical studies have shown no rectal bioavailability of unadulterated THC. And while it’s plausible to speculate that cannabinoids could have an effect via local pathways in the colon and elsewhere, those pathways haven’t been studied yet. Although many anecdotal reports are positive, there are some significant discrepancies in observed efficacy. Far more research is needed to better understand exactly how this method works (or doesn’t).

But there’s no need for patients to wait until all the results are in. If you’re curious, suppositories could be worth a try. You probably won’t get a “head high,” according to the legendary Tommy Chong, who uses cannabis suppositories under a doctor’s supervision. Though you might feel a little “butt high,” Chong says with a smile, which is not necessarily a bad thing. Whether or not cannabinoids are absorbed into the bloodstream from the rectum, many suppository enthusiasts report powerful, localized, non-psychotropic effects for a range of middle and lower body afflictions.

ANAL SUPPOSITORIES

Men and women have reported using rectal suppositories to treat anal fissures, hemorrhoid inflammation, digestive issues, Crohn’s and IBS, sciatica, restless leg syndrome, lower back pain, prostate issues, and post-operative pain. Rectal suppositories are also being used for lubrication to mitigate pain during anal intercourse. 

Más 


 

miércoles, 6 de octubre de 2021

España: Epidyolex primer medicamento a base de cannabis


 

 

 

 

 

Eva S. Corada @evacorada 

 

Ya es una realidad: el primer medicamento exclusivamente a base de cannabidiol (CBD) -sustancia química extraída del cannabis- aprobado ya está disponible en nuestro país. Aunque, eso sí, será dispensado en a través de la farmacia hospitalaria para su uso como tratamiento -junto con clobazam- de la epilepsia. En concreto para las crisis asociadas al síndrome de Lennox-Gastaut (SLG) y al síndrome de Dravet (SD) en pacientes a partir de dos años de edad.


Epidyolex
-que es cómo se llama el fármaco- es una solución oral que contiene cannabidiol (CBD) altamente purificado. En septiembre de 2019 recibió la aprobación de la Comisión Europea, lo que le convirtió en el primer medicamento de prescripción a base de cannabis derivado de plantas en recibir esta autorización. La aprobación de cannabidiol solución oral se basó en los resultados de cuatro ensayos de fase III controlados y aleatorizados conn datos de más de 714 pacientes con ambas patologías. España ha participado en el desarrollo clínico de esta terapia con más de diez hospitales.

“El acceso a un nuevo medicamento con un mecanismo de acción novedoso y clínicamente probado es un motivo de esperanza para los pacientes y de satisfacción para los especialistas que vemos a menudo pacientes con epilepsias altamente resistentes”, afirma Antonio Gil-Nagel Rein, neurólogo y director del Programa de Epilepsia del Hospital Ruber Internacional de Madrid, quien señala que “la potencial mejora de la calidad de vida en un área donde las opciones terapéuticas son muy pequeñas es una buena noticia”.

../...


Pero ¿cómo funciona? Tal y como explica el director médico del Área de Epilepsia de Jazz Pharmaceuticals en España, Ángel Ayuga, este medicamento “utiliza un mecanismo de acción novedoso ya que reduce la hiperexcitabilidad neuronal y la inflamación a través de la modulación del calcio intracelular y de los neurotransmisores en la neurona presináptica”.

Los síndromes de Lennox-Gastaut (SLG) y Dravet (SD) son dos formas raras de epilepsia con elevados índices de morbilidad y mortalidad, y que suponen una importante carga para las familias y los cuidadores. Muchos pacientes con SLG o SD tienen múltiples crisis epilépticas cada día, lo que les coloca en riesgo constante de sufrir caídas y lesiones. A pesar del actual tratamiento con medicamentos antiepilépticos, estas dos graves formas de epilepsia son muy resistentes al tratamiento.

Más

Ver: Cannabinoides en PHARMACOSERÍAS

jueves, 11 de marzo de 2021

La Comisión Europea aprueba el canabinoide EPIDYOLEX®

 


EPIDYOLEX® (cannabidiol o CBD), acaba de ser aprobado por la Comisión Europea para el tratamiento de los síndrome de Dravet y Lennox-Gastaut.

Tras ensayos clínicos en más de 700 pacientes, los resultados mostraron que este fármaco es eficaz para reducir la frecuencia de las convulsiones en comparación con el placebo.

Desde la Fundación Síndrome de Dravet llevamos ya muchos años aportando nuestro granito de arena junto a la industria, reguladores y pacientes para que este fármaco llegue a mercado y sea uno más para tratar el síndrome de Dravet, que representa la esperanza para los muchos individuos que viven con convulsiones intratables y epilepsias refractarias, que cada día se enfrentan a convulsiones con el riesgo continuo de lesiones graves e incluso la muerte.


“El síndrome de Dravet y de Lennox-Gastaut son dos de las formas más graves y difíciles de tratar de la epilepsia de inicio en la infancia, y pocos pacientes logran un control adecuado de las convulsiones”, dijo el profesor Elinor Ben-Menachem, Universidad de Gotemburgo, Academia y Hospital Sahlgren en Suecia. . “La aprobación de EPIDYOLEX® traerá esperanza a los pacientes y sus familias, con el potencial de controlar mejor las convulsiones y mejorar la calidad de vida”. (Ver)

domingo, 7 de marzo de 2021

Maximillian White: El "rey" del cannabis medicinal vive en Mallorca

Mallorca es lugar de residencia de multimillonarios, los que hicieron fortuna con los valores tradicionales, y los que la han hecho explotando nuevos —y llamativos— nichos de negocio. Es el caso de Maximillian White, conocido como el magnate del cannabis medicinal. Nacido en Nottingham hace 40 años, es la primera persona que ha amasado una fortuna en una industria que está en pleno florecimiento. Además es una estrella de Instagram, donde suma más de cuatro millones de seguidores. 

La revista ‘Forbes’, interesada en los personajes más acaudalados del planeta, publica en su último número una entrevista a White, ilustrada con fotos tomadas en su casa de Mallorca, en el entorno de la Serra de Tramuntana. 

«Es posible que aún no hayas oído hablar de él, pero este recién llegado a la industria se convertirá en el primer multimillonario del cannabis medicinal a la tierna edad de 40 años», escribe la periodista a modo de introducción. 



Este emprendedor, que reparte su tiempo entre Londres, Dubái y su lujosa residencia de la isla, empezó siendo el dueño de un pub más joven de Inglaterra y ahora, tras un exitoso paso por la industria musical y el mundo inmobiliario, es un magnate del incipiente sector del cannabis medicinal. White es «dueño de cuarenta hectáreas de tierra en Portugal para cultivar cannabis medicinal con una producción estimada de 1.500 millones de euros en valor de mercado al año», escribe Forbes. «Se convertirá en el primer multimillonario de esta industria (sus acciones están valoradas en 3.500 millones de euros)», añade esta publicación. 

White declara que su éxito se debe no tanto a una cuestión de oportunidades sino de personalidad. «Se necesita valor para no importarte ser odiado, escudriñado o el centro de atención. Hay que tener la piel dura, la capacidad de enfrentar las críticas y seguir adelante sin importar el ruido», indica el emprendedor, que exhibe un suntuoso reloj, zapatos exclusivos y joyería. 

De hecho, casi toda la conversación gira en torno a la moda y el diseño, ámbito en el que White se mueve con comodidad hasta el punto de marcar tendencias en @thatboyyouhate, su popular cuenta de Instagram. 

White ha hecho fortuna en la industria del cannabis medicinal al calor de una legislación internacional cada vez más permisiva con la marihuana si se cultiva con fines terapéuticos. (Ver)

 


Cannabis Entrepreneur Makes Between £1 Billion And £3 Billion A Year Selling Medicinal Marijuana 

Max's company is 100 percent dedicated to the pharmaceutical market, so much so that they are currently formulating exclusive strains based on DNA samples. 

He said: "We'll be able to send a swab to your house. And with the information from that swab, we'll be able to know what kind of problems you're going to have within the next 10 years and we'll be able to build a strain of marijuana especially for your body and your ailments over the next 10 years". 


"There will be an app that gives us second to second, minute to minute of your sleeping, your heartbeat, how you're dealing with the medication and the information will be sent back to us so we know where we can tweak it at a later date." If you were thinking of popping on a flight over to the Algarve (Covid-dependant, of course), buying a plot of land and growing some weed, it's not going to be quite as easy as that. 

 Max explained: "It's five years in the making. It's not an accident, there's been a lot of hard work there. I've taken a lot of risks that 99.9 percent of people wouldn't take. It's not the same as buying a little allotment." 

Speaking about the money he's bringing in, he added: "If we just look at one of our farms, we're looking to do 108,000 kilos a year. At €5 a gram it's about €540 million". 

"That would be one of our farms. I have three, some bigger. I'd say I'm bringing in anywhere between €2 to €4 billion."(Más)

                                            UK apuesta por los cannabinoides...


The luscious green plants stretch as far as the eye can see. Row after row, lovingly tended in a glasshouse that’s roughly the same size as 34 football pitches.

Thought to be one of the UK’s largest glasshouses, the 45-acre glasshouse in Wissington, Norfolk, sits in an area known for the growing of crops, vegetables and fruit, from peas and beans to tomatoes and strawberries. But this crop is slightly different. Once filled with tomato plants, the glasshouse owned by British Sugar is now home to hundreds of thousands of cannabis plants grown for the pharmaceutical company GW Pharmaceutical.

Carefully cultivated at GW’s research facility in Kent, the plants are reared on an industrial scale in Wissington with high levels of cannabidiol – or CBD – and very little THC (Tetrahydrocannabinol), the psychoactive element commonly associated with marijuana. It makes them perfect for approved and regulated epilepsy drugs. (Más)

Ver todo sobre GW Pharmaceuticals en PHARMACOSERÍAS

jueves, 16 de enero de 2020

España: Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Spain (I)


Cannabinoid Drugs

For the purposes of this topic shall mean any industrially produced medicinal product which contains cannabinoids.

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid Drugs may be authorized in Spain on the basis of scientific criteria on its quality, safety and efficacy. The foregoing is provided that applicable regulations on narcotics, such as Law 17/1967 on narcotics, and Royal Decree 2829/1977 on narcotics and its production, distribution, prescription and dispensation are observed.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The main Spanish authorities with jurisdiction over Cannabinoid Drugs are the Spanish Ministry of Health and the AEMPS.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

No. The general regulatory framework applicable for the authorization, pricing and reimbursement of medicinal products apply to Cannabinoid Drugs.

There are, however, specific regulations that may be applicable to other activities related to Cannabinoid Drugs such as manufacturing, distributing, prescribing, dispensing etc. (see, among others, Law 17/1967, Royal Decree 2829/1977 and Royal Decree 1675/2012 on prescribing and dispensing narcotics for both human and veterinary use).

4. Which are the cannabinoid drugs that have received market approval to date?


To date, only Sativex 2,7 mg / 2,5 mg Oromucosal spray solution (“Sativex®”) has received market approval in Spain. Sativex® is a Cannabinoid Drug which contains, per each single 100 microlitre spray, 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) from Cannabis sativa L. 
The marketing authorization holder of Sativex is GW Pharma Ltd. 

Ver:
Todo sobre GW Pharma en PHARMACOSERÍAS

Sativex® has been classified as a hospital diagnosis drug, which means that it shall only be used for the treatment of diseases diagnosed either in hospitals or centers which have appropriate diagnosis means, or by specialized doctors (see art. 24.3.b of Royal Decree 1345/2007 on the procedure for authorization of industrially produced medicinal products for human use).

Likewise, according to section 4.1 of the technical sheet of Sativex®, Sativex® must only be used “to improve symptoms of adult patients with moderated or serious spasticity due to multiple sclerosis” if “other anti-spasticity medicines have not worked” and “a significant clinical improvement has been observed regarding the symptoms of spasticity after an initial trial period of the treatment”.

5. Who can prescribe Cannabinoid Drugs?

Doctors, odontologists and veterinaries, each of them in the field of its competence, can prescribe narcotic drugs.


6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There is not a list of doctors authorized to prescribe Cannabinoid Drugs. Doctors, provided that they comply with the applicable requirements and procedures (which include the need to use the appropriate prescription forms), can prescribe Cannabinoid Drugs without need to be previously registered in any official list. It is to be noted that doctors holding prescription forms for narcotic drugs may be controlled (and, therefore, somehow listed) but these are lists relating to the prescription forms (holders of such forms are listed) and not related to the doctors themselves.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Provided that applicable regulations are complied with (including the use of the appropriate prescription forms), doctors themselves do not have to ask for any specific approval or make any specific notification each time they prescribe Cannabinoid Drugs.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Cannabinoid Drugs can be dispensed to the public by authorized pharmacy offices/services.

Cannabinoid Drugs can be distributed (that is, sold to either other authorized distribution entities or pharmacy offices/services) by any of the following entities provided that they comply with all applicable regulations on medicinal products and narcotics (such as Law 17/1967, Royal Decree 2829/1977 -and its complementary regulations- and Royal Decree 1675/2012):

Pharmaceutical laboratories; Distribution entities duly authorized to distribute medicines for human use (see Royal Decree 782/2013 on distribution of medicinal products for human use); and/or Distribution entities duly authorized to distribute veterinary medicines (see Royal Decree 109/1995 on veterinary medicinal products).

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

Retailers. The AEMPS, with the cooperation of the regional authorities, publishes lists including all pharmacy offices opened to the public in Spain. Such pharmacy offices can dispense Cannabinoid Drugs if they comply with applicable regulations (please refer to Question 8). Distributors. 
The AEMPS publishes lists including all entities authorized to distribute veterinary medicines and medicines for human use in Spain. All entities authorized to distribute Cannabinoid Drugs must be included in such lists.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

We are not aware of any proposal to significantly reform the regulation of Cannabinoid Drugs in Spain.

11. When are they likely to come into force?

N/A



Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide. 
Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from 
The Pharma Legal Handbook: Spain




miércoles, 20 de noviembre de 2019

NICE: SATIVEX ok en MS
















The National Institute for Health and Care Excellence (NICE) has recommended Bayer’s Sativex (delta-9 tetrahydrocannabinol (THC) cannabidiol (CBD)), for spasticity in people with multiple sclerosis (MS).

Ver:

SATIVEX: Esplendor en la "yerba" para Bayer


The cannabis-based medicinal product has been approved within its licensed indication, as the organisation deemed it clinically and cost effective at its current list price. NICE also updated the MS Guideline to state that Sativex should be offered to treat spasticity in people with the disorder.

The news follows a previous positive health technology appraisal of the treatment in spasticity by the All Wales Medicines Strategy Group (AWMSG).

Sativex, developed by GW Pharma and marketed in the UK by Bayer, has been approved for use in the United Kingdom since June 2010 for the treatment of some symptom improvement in adult patients with moderate to severe spasticity due to MS.



Ver también:

Sativex: Cuestión de pr_incipios?...No, de pr_ecios.



The new guideline has been hailed as “very positive for people living with moderate to severe MS spasticity who are not responding to their current medication.”

Dr Jackie Napier, medical director, neurology at Bayer explained that the company “looks forward to the rapid implementation of this guideline to broaden the range of treatment options currently available.”

It is estimated that MS affects 100,000 people in the UK with spasticity a common symptom and major contributor to disability. Spasticity can range from mild muscle stiffness to severe, painful and uncontrollable muscle spasms, and as a consequence an individual may have difficulty in walking, picking up objects, washing, dressing and other everyday activities involving movement. Ver




Ver:
Todo sobre SATIVEX en `PHARMACOSERÍAS

jueves, 9 de agosto de 2018

MEXICO: Ex Presidente Fox KOL para KHIRON.

.
After participating in CannaMexico 2018, a prominent medical cannabis conference hosted by Centro Fox, it was clear that the collaboration between Khiron, former President Fox and Centro Fox provided the opportunity to greatly advance our shared interests in increasing the level of education and understanding of the benefits of medical cannabis for all of Latin America.


His appointment to our board also significantly expands our scope of influence and relationships within the Latin American market.



Appointment expands business and political network and furthers development of medical cannabis education and research across Latin America

TORONTO, July 17, 2018 /CNW/ – 

Khiron Life Sciences Corp., a Canadian integrated medical cannabis company with its core operations in Colombia, announced today that the Company has appointed former President of Mexico Mr. Vicente Fox Quesada to its board of directors, effective immediately. Mr. Fox will be a strategic advisor and brand ambassador for the Company, furthering the Company’s education and brand leadership interests across Latin America. 
From December 2000 to November 2006, Mr. Fox was the 55th President of Mexico. Prior to that, he was the Chief Executive Officer of Coca Cola Latin America.

Mr. Fox is the Founder of Centro Fox, a nonprofit foundation dedicated to serving communities in Mexico and Latin America. Through his various business and community interests, Mr. Fox has been a high profile and respected advocate for the legalization of medical cannabis throughout the Latin American region. He currently serves on the board of directors of a leading US based cannabis publication advocating legalization.

Further, this appointment puts us in a strong position to expedite our expansion plans to other strategic markets, keeping with our goal of becoming the dominant regional medical cannabis company in Latin America. On behalf of the board of directors and Khiron team, I welcome former President Fox to Khiron.

As previously announced, Khiron is strategically positioned to enter the Mexican market, establishing a subsidiary in the country to submit license applications, completing an in-depth regulatory review of the country’s legal medical cannabis landscape as well as an assessment of market needs. Mexico comprises a population of approximately 123.5 million people, with nearly 11.7 million potential patients for medical cannabis.


To Centro Fox and President Fox this represents a great opportunity to accomplish our dream of reducing violence in Mexico due to the underground and illegal crime activities related to Cannabis and move to a new legal industry creating jobs and income for families, taxes to governments and wealth creation, as well as innovative and creative actions to strengthen citizens and families’ health.


About Khiron Life Sciences Corp.

Khiron Life Sciences Corp. is positioned to be the dominant integrated medical cannabis company in Latin America. Khiron has core operations in Colombia and is fully licensed in the country for the cultivation, production, domestic distribution, and international export of both tetrahydrocannabinol (THC) and cannabidiol (CBD) medical cannabis. 
In May 2018, Khiron listed on the TSX Venture Exchange, becoming the first Colombian based medical cannabis company to trade on any exchange globally.

With a focused regional strategy and patient oriented approach, the Company combines global scientific expertise, agricultural advantages, branded product market entrance experience and education to drive prescription and brand loyalty to address priority medical conditions such as chronic pain, epilepsy, depression and anxiety in the Latin American market of over 620 million people. Khiron is led by Co-founder and Chief Executive Officer, Alvaro Torres, together with an experienced executive team, and a knowledgeable Board of Directors that includes former President of Mexico, Vicente Fox. (Más)

miércoles, 27 de junio de 2018

USA: FDA aprueba EPIDIOLEX primer cannabinoide

.


The Food and Drug Administration on Monday approved the country’s first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.

The drug, GW Pharmaceuticals’ Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes. 

Ver:

GW Pharmaceuticals dobla su valor gracias al cannabis (Epidiolex)


“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”

The FDA’s decision was expected. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light. There was some concern about the drug’s effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment. (Ver)

martes, 29 de mayo de 2018

Una docena de blockbusters para 2018...

.



Marta Riesgo Madrid 04 may 2018 - ElGlobal.net

Durante este año 2018 son numerosos los medicamentos que se lanzarán al mercado y que están llamados a ser blockbusters. Así se desprende del informe Drugs to Watch publicado por la consultora Clarivate Analytics y que apunta a que serán una docena los fármacos que revolucionarán el mercado.


En el primer lugar de la tabla, ordenada por previsiones de ventas, se encuentra Hemlibra (Emicizumab), de Roche, que precisamente fue aprobado por la Comisión Europea el pasado mes de febrero. Este fármaco, llamado a obtener ingresos que superen los 4.000 millones de dólares en 2022, esta indicado como tratamiento profiláctico de rutina para prevenir episodios de sangrado en pacientes con hemofilia A con inhibidores del factor VIII. Hemlibra puede ser utilizado en todos los grupos de edad. 
Este 2018 las previsiones de ventas para el fármaco de Roche alcanzan los 496 millones de dólares.

En segundo lugar se encuentra Biktarvy (bictegravir/emtricitabina/tenofovir alafenamida), de Gilead, para el tratamiento del VIH-1. Se trata de un nuevo tratamiento antirretroviral completo en un único comprimido de una sola toma diaria, que ya ha recibido la aprobación de la FDA en febrero y que se encuentra pendiente para la aprobación definitiva por parte de la Comisión Europea tras la recomendación emitida por la EMA. 
En concreto, la consultora lanza una previsión de ventas de cara a 2022 para este fármaco que superan los 3.700 millones de dólares. En 2018 este medicamento ingresará 896 millones de dólares. La evolución en ventas de este fármaco será de las más rápidas pues, para 2019, ya alcanzará los 2.200 millones de dólares.

Ozempic (semaglutida), de NovoNordisk, indicado para la diabetes tipo 2 es el tercer fármaco situado en el ranking. El pasado mes de febrero este medicamento recibía la aprobación definitiva por parte de la Comisión Europea. Se trata de un nuevo análogo del péptido similar al glucagón tipo 1 (GLP-1) administrado una vez a la semana e indicado como monoterapia, cuando la metformina ya no aporta los resultados esperados o está contraindicada, y en combinación con otros tratamientos para la diabetes. 
En concreto, este nuevo fármaco está llamado a alcanzar unas ventas en 2022 de 3.460 millones de dólares, según la consultora. Para este 2018 las ventas estimadas alcanzan los 260 millones de dólares. Este medicamento aporta reducciones superiores y sostenidas de la HbA1c (hemoglobina glicosilada) y en el peso corporal frente a otros tratamientos, junto con beneficios cardiovasculares y la reducción estadísticamente significativa de la nefropatía diabética.

Sólo un fármaco oncológico 


A diferencia de otros años, en este caso sólo un medicamento afecta al área de oncología. Se trata de Erleada (apalutamida), de Janssen, para el tratamiento de pacientes con cáncer prostático no metastásico y resistente a la terapia de castración. Erleada trabaja cegando el efecto de andrógenos, un tipo de hormona, sobre el tumor. Estos andrógenos, tales como testosterona, pueden ascender incremento del tumor. Precisamente el pasado febrero este medicamento recibió la aprobación por parte de la FDA, siendo el primer tratamiento aprobado en Estados Unidos para el cáncer de próstata no-metastático, castración-resistente. 
Según el informe, este nuevo medicamento podría alcanzar unas ventas en 2022 que superen los 2.000 millones de dólares. Para el cierre de año las ventas de Erleada serán de 25 millones de dólares.

Shingrix, de la farmacéutica GSK, para prevenir el herpes zóster y la neuralgia postherpética ocupa el quinto puesto en el ranking. Esta proporciona una protección del 90 por ciento contra esta enfermedad infecciosa, mientras que la efectividad aproximada de Zostavax —la vacuna comercializada en la actualidad— es del 50 por ciento. La nueva vacuna, desarrollada por la empresa farmacéutica GSK, y que se administra por vía intramuscular mediante dos inyecciones, ya había sido autorizada por la FDA estadounidense en octubre de 2017 y el pasado mes de marzo recibió el visto bueno en Europa. 
Las ventas estimadas para 2022 superan los 1.300 millones de dólares. Este 2018 los ingresos calculados alcanzarán los 242 millones de dólares.

Un huérfano con grandes previsiones

 Patisiran, de Sanofi y Alnylam Pharmaceuticals, se sitúa en la mitad de la tabla. Precisamente ambas compañías solicitaron el pasado mes de enero la aprobación regulatoria europea para el nuevo RNAi terapéutico dirigido a la transtiretina. El pasado febrero la agencia norteamericana concedió la solicitud de revisión prioritaria (Priority Review) y estableció la fecha de acción de la Ley de Cuotas de los Usuarios de Medicamentos Recetados (PDUFA) para el 11 de agosto de 2018. El PDUFA permite a la agencia acelerar el proceso de revisión para los nuevos medicamentos. Se trata de un programa de cuotas anuales pagadas por el sector farmacéutico que la agencia usa para ayudar a evaluar nuevos medicamentos antes de aprobarlos. 
Este fármaco obtendrá unas ventas en 2022 de 1.212 millones de dólares.

Epidiolex (cannabidiol o CBD), de GW Pharmaceuticals, como tratamiento adyuvante para las crisis asociadas al síndrome de Lennox-Gastaut (LGS) y el síndrome de Dravet, dos formas de epilepsia infantil muy resistentes al tratamiento también se incorpora a la lista de futuros superventas. 
Este fármaco podría superar los 1.100 millones de dólares en ventas para 2022.

El resto de fármacos que se incluyen en el ranking son Aimovig (Erenumab), de Novartis, para el tratamiento de la migraña, con unas ventas que alcanzarán los 1.170 millones de dólares; Lanadelumab, de Shire, para el angioedema hereditario, con 1.150 millones de dólares de previsión; Elagolix, de Abbvie, para la endometriosis que alcanzará los 1.150 millones de dólares; Steglatro (ertugliflozin), de Pfizer y MSD, para la diabetes tipo 2, que alcanzará los 1.087 millones de dólares; y Sublocade (buprenorphine de liberación prolongada) de Indivior, con una facturación estimada para 2022 de 1.072 millones de dólares. (Ver)

martes, 8 de mayo de 2018

Para_Pharma_Lia: MedChew RX / AXIM

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La marihuana contiene más de 100 cannabinoides, pero los más populares y útiles médicamente son el cannabidiol (CBD) y el tetrahidrocannabinol (THC) .

La nueva patente permite a AXIM “garantizar la entrega de todos los cannabinoides” sintéticos y naturales y, entre ellos el THC, aunque sin provocar un efecto psicoactivo.

Este medicamento en forma de goma de mascar o chicle sólo estará disponible para el mercado farmacéutico. En otras palabras, sólo se podrá obtener recetado por un médico.




AXIM no es ajeno al mercado de la goma de mascar con marihuana. La compañía ha ganado su notoriedad después del debut de su primer producto similar el CanChew. Para la producción de los cristales de CBD se utilizó un nivel de pureza del 99,9%.

El nuevo producto MedChew RX incluye el CBD y el THC , y está siendo probado en ensayos clínicos. Se espera que el producto medicinal se utilice para el tratamiento del dolor y para la reducción de los espasmos musculares en pacientes con esclerosis múltiple, problemas reumáticos como artritis, artrosis y fibromialgia entre otras dolencias.

La compañía espera que la tercera fase de los ensayos clínicos se completen en el tercer o cuarto trimestre del 2017 y luego será presentado para su aprobación a la Administración de Alimentos y Medicamentos y a la Agencia Europea de Medicamentos.

Se espera que el MedChew RX sea registrado en el 2018.
“No todos los chicles o goma de mascar con THC son lo mismo. Hay muchos otros productos en el mercado, pero no contienen cannabinoides puros y sin ningún tipo de contaminación “. AXIM utiliza su propio método de extracción para obtener el THC puro de alta calidad. Este proceso también ayudará a vender el producto aproximadamente en un 20% más barato que el actual CanChew, que se vende por $ 56 el paquete de 33 chicles; mientras baja el precio yo uso una crema calmante de cannabis. (Ver)

Ver también:

Humor...es lunes:HandzOff/Medica_mentalización del "amor propio"...no es paja.

Para_pharma_lia: Chicles Stevia / Ufff...

Chicles de "salud"...