Primer Blog "específico" de Marketing Farmacéutico para países de habla hispana.
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.
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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.
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.
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.
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.
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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.
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.
“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”.
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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.
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.
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.
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".
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...
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
“Dum loquimur,
fugerit in vida aetas:
CARPE DIEM
quam minimum credula postero”
“Mientras hablamos,
habrá huido celosa la edad:
goza a bocados del momento,
confía lo menos posible
en el mañana”