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.

Jazz Pharmaceuticals compra GW.

 

Jazz Pharmaceuticals paga 6.000 millones de euros para comprar GW, que comercializa fármacos contra la esclerosis múltiple o la epilepsia con derivados de cannabis

Nuevo salto de Jazz Pharmaceuticals. La compañía, que a finales de 2019 selló un contrato milmillonario con Pharma Mar para comercializar el antitumoral Zepzelca en Estados Unidos, ha anunciado que desembolsará un total de 7.200 millones de dólares (unos 6.000 millones de euros al cambio actual) para hacerse con el control de GW Pharmaceuticals. 

Ver:

Pharma Mar: Goldman Sachs también quiere pescar...en Galicia 

La adquisición se articulará a través de un pago de 200 dólares por acción y la entrega de 20 dólares en acciones. Según asegura Jazz Pharmaceuticals, el acuerdo está previsto que se cierre a lo largo del segundo trimestre y permitirá elevar la facturación de Jazz a un ritmo de doble dígito tras pasar a hacerse con el control de fármacos como el Nabiximoles o el Epidiolex. Se trata de dos de los fármacos estrella de GW Pharmaceuticals.

El primero está dedicado al tratamiento de la esclerosis múltiple y fue primer derivado natural de la planta de cannabis en recibir este tipo de autorización en todo el mundo. El segundo, por su parte, está enfocado al tratamiento de la epilepsia en niños. (Más)

The Latin América&Caribbean Cannabis Report

 

Pharmaceutical cannabis

• Formulated, processed, or synthetic cannabis sold as finished products, which have undergone full medical trials, and hold (in one or more geographical areas) a medical marketing authorisation* e.g. Cesamet®, Marinol®, Syndros®, Sativex®, Epidiolex® and any derived generic medicines; or

• Cannabinoid-based API (Active Pharmaceutical Ingredient), which is registered as an API in a medicinal product holding marketing authorisation* in one or more geographies, to be manipulated and/or compounded by a magistral pharmacy to produce a cannabinoid-based medicine.

Medical cannabis

• Cannabinoid-based medicine not holding marketing authorisation and therefore sold as an unlicensed medicine supplied through health systems and prescribed by a doctor; or 

• An API to be manipulated and/or compounded by a magistral pharmacy in order to prepare a cannabinoid-based medicine without marketing authorisation (unlicensed).

Medicinal cannabis

Term used to indicate all cannabinoid based therapeutic products (medical + pharmaceutical).

 

Latin America and the Caribbean (LAC) holds a special place in the minds and hopes of everyone that is involved in the cannabis sector around the planet, including the team here at Prohibition Partners. 

 The cannabis plant has featured in the history of the region since the colonial era when African slaves brought cannabis seeds to the continent. As usage spread to indigenous populations and production flourished across the continent, consumption of cannabis often became the subject of prohibition as a form of oppression against the unprivileged layers of society, to be followed by a war on drugs, which left scars across the region and has been questioned by many. However, cultivation and use have continued in LAC, leading to an amazing know-how with regards to the genetics and varieties of the cannabis plant in the region, which is helping to shape LAC’s potential in this sector today. 

Since Uruguay’s pioneering legalisation of cannabis in 2013, followed by Colombia in 2016, the LAC region has been at the centre of international interest due to its favourable climate, fertile soils, low labour costs and  large domestic population. A number of large operations have been set up, although commercial success has been limited due to tough regulatory requirements on both sides of the Atlantic as well as slower investment into emerging markets following the poor Q3 2019 results of large cannabis players in Canada. 

Nevertheless, the disruptive potential of the region both as a supplier and a consumer market is undeniable. Through leveraging LAC’s competitive advantages and the growing trends in telemedicine and last-mile delivery in an increasingly digitalised and urban society, the potential is exciting, particularly when taking into account the potential of hemp in sustainability and regeneration. We at Prohibition Partners are firmly committed to helping the local cannabis and hemp industry to develop and grow. For this reason, we have decided to establish an office in São Paulo, Brazil, where I am based, and from this city we will continue to strengthen our presence in the region and help local operators, investors and regulators succeed in this exciting sector with a promising future.

 Hector Gomes de Sousa LAC Analyst Prohibition Partners

 

 

Novartis concluye primer gran negocio global de cannabinoides.

In a watershed moment for medical cannabis advocates in the United States, Swiss giant Novartis' Sandoz AG unit has tied up with Tilray, a Canadian medical cannabis producer, marking perhaps the first big endorsement of the controversial plant by a large, multinational pharmaceutical company.

Ver también: 
Sandoz / Novartis y la marijuana (no "combustible")...
 
The deal exemplifies changing attitudes in the US, where more Americans live in states that have legalized the sale of medical and/or recreational cannabis than in anti-cannabis jurisdictions. Tilray, which supplies cannabis flower and extract products to patients, physicians, healthcare facilities and researchers in 12 countries, has an existing alliance with Sandoz Canada.
   
Under the so-called framework agreement, Sandoz AG may support Tilray in commercializing and branding the Nanaimo, British Columbia-based company's non-smokable/non-combustible products; the Canadian pot producer may supply and/or license such products to and from Sandoz AG; and significantly, the two may collaborate in developing such products.

"The (expanded) partnership also helps legitimize cannabis in international markets, which could impact prevalence within existing markets as well as help influence countries considering medical cannabis legalization," Cowen's Vivien Azer wrote in a note.

The landmark FDA approval of GW Pharma's cannabis-derived medicine Epidiolex earlier this year paved the way for a plethora of small and mid-sized drug developers — including Insys Therapeutics, Zynerba, InMed Pharma, Kannalife and Axim Biotech — that are hoping to hitch their wagon to the cannabis star, either by developing synthetic or natural cannabis-derived therapeutics or devising novel delivery mechanisms for its absorption. 

Ver:

GW Pharmaceuticals dobla su valor gracias al cannabis (Epidiolex)

Two big deals over the course of this year have also underscored the lucrative potential of the plant, with alcohol giant Constellation Brands spending a mammoth $4 billion to secure a 38% stake in Canadian cannabis company Canopy Growth, and cigarette maker Altria forking out $1.8 billion to take a 45% stake in another Canadian pot company Cronos.

Meanwhile, the US federal government continues to consider cannabis as a schedule 1 substance — on par with LSD and heroin — with no medical value, infuriating researchers who contend the classification has dramatically slowed the scientific and medical investigation of the plant. Nevertheless with House Democrats taking back seats this November, pro-marijuana legislation is expected to heat up.

"There is ample evidence that the cannabis plant has numerous useful applications in medicine and the law is obsolete," said Marc Feldmann, an Oxford professor and immunologist whose work led to the discovery and subsequent commercialization of the world’s largest selling drug class, anti-TNF. "This classification is changing around the world – it has already happened in Canada and will happen in more states in the US in due course," he said in a previous interview with Endpoints News. Feldmann also serves as CEO of CannBioRex, a Canada-based company that is developing synthetic cannabis-derived medicines.(Ver)

Marijuana green grey zone...patients, Dr´s & pharmaceuticals.

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If you live in one of the 20 states where marijuana is legal but only for medical use, access to the drug begins at the doctor's office. But unlike most other treatments, it is not granted via a prescription pad.

That's because marijuana remains a schedule 1 substance. (Physicians can only write prescriptions for schedule 2 drugs or higher.) This classification encapsulates a wider paradox: marijuana is defined as a drug with no medical value and a high potential for abuse by the federal government, but it is now legal for medical use in most states. Once dismissed as a drug for slackers, marijuana has entered the mainstream so completely it's been embraced by wellness enthusiasts. Sixty-one percent of Americans support its legalization.

But because the federal government continues to classify marijuana as a schedule 1 drug, along with heroin and LSD, it's very difficult for researchers to study its health effects. While the available evidence suggests marijuana can be an effective treatment for chronic pain, the body of studies is far from robust.

Meanwhile, doctors are barred from prescribing cannabis products. Instead, certified physicians in states where the drug is legal can provide patients with a medical marijuana card.

The disconnect likely contributes to the overall confusion and lack of information surrounding marijuana's medical benefits. Patients are increasingly curious about the drug, but doctors often don't have answers. In a recent survey of oncologists published in the Journal of Clinical Oncology, around 80% said they've discussed marijuana with their patients in the past year, but only 30% felt they have enough information to advise patients on its medicinal use.

Even for providers who are informed about the drug and can talk knowledgeably about treatment options, such guidelines aren't easily integrated into a patient's health records. Because of the drug's scheduling, doctors can suggest dosages and products (most doctors likely won't recommend that a lung cancer patient smokes a joint, for example), but they can't prescribe anything specific. Instead, patients visit a dispensary, card in hand, and select what they want.

“Physicians are cut out of the loop,” said W. David Bradford, a professor of public policy at the University of Georgia. Rescheduling marijuana would allow physicians to write cannabis prescriptions, and “integrate it into a care plan.” It would open the door, albeit a crack, for pharmaceutical companies to work with dispensaries to create more uniform doses of the product, as Sandoz has done in Canada. Patients, particularly those with complex drug regimens, could benefit from an added layer of coordination and precision.

Ver: 
Sandoz / Novartis y la marijuana (no "combustible")...

Dr. Andrew Epstein, an oncologist with Memorial Sloan Kettering Cancer Center in New York City, supports marijuana's use to help with pain, nausea, and fatigue after more traditional medical treatments have been tried and exhausted. But unlike Bradford, he does not feel the drug is not ready for the prescription pad treatment.

Researchers simply don't know enough about what marijuana can – and can't – do to justify having doctors prescribe the drug in specific dosages, he said. “I'm concerned it would add to the confusion.” (...)

Impact on pharma

Despite doctor's inability to prescribe the drug, medical marijuana is nonetheless having an effect on prescribing patterns.

In every state where medical cannabis has been legalized it has “this benefit of people being able to use less prescription medication,” said Jessica Gelay, a policy manager at the Drug Policy Alliance. Indeed, a recent study published in JAMA Internal Medicine by Bradford and colleagues found that after states legalized medical marijuana, opioid prescriptions under Medicare Part D declined significantly. 

Ver

In those states that introduced a system of dispensary outlets, opioid prescriptions under Medicare Part D dropped by 14.5% following legalization. “People are reacting to the availability of cannabis as if cannabis was medicine,” Bradford said. “They're doing exactly what they would do if a pharma company introduced a new blockbuster drug.”

Bradford estimates that if every state were to turn on a dispensary-based cannabis program, Medicare and Medicaid spending would drop by around $4 billion to $6 billion. Legalization represents a potentially significant “reduction in the revenue flowing to prescription drugmakers.” 

Which hasn't gone unnoticed by manufacturers. Some have publicly lashed out: Insys, an opioid maker, contributed $500,000 to an anti-legalization campaign in Arizona, for example. 
Others (including, ironically, Insys again) have invested in harnessing elements of the drug to create FDA-approved treatments.

The FDA is expected to green light an epilepsy medication from GW derived from marijuana later this summer. If the decision goes through, it would be the first cleared drug made from the marijuana plant, although the agency has already approved a few drugs derived from synthetic cannabinoids.

The approval would open the door for other medications derived from marijuana, particularly those, like GW's epilepsy drug, that do not contain properties that make users high. For broad, lucrative categories such as pain management, however, marijuana-based medications could lack the financial windfall necessary to justify heavy R&D investment.

“You can't patent the cannabis plant,” Bradford said. Were a manufacturer to invest heavily in determining the most effective strains and dosages for treating chronic pain, “everyone could just go buy it from their local dispensary instead.” (Más)

Ver también:

USA: FDA aprueba EPIDIOLEX primer cannabinoide
SANDOZ con Tilray (pioneros) y la marijuana "no cumbustible"

SANDOZ con Tilray (pioneros) y la marijuana "no cumbustible"

"THIS INDUSTRY HAS ITS SHARE

OF GREAT ANNOUNCEMENTS,

BIG EGOS AND EMPTY PROMISES,

WHEREAS TILRAY HAS HIT ITS MILESTONES QUIETLY,

ONE AT A TIME."

Brendan Kennedy

Tilray’s founder and CEO 

• -Sandoz Canada and Tilray finalize alliance to provide Canadians with greater access to high-quality, non-combustible medical cannabis options; 
• -Eight co-branded oil and capsule medical cannabis products are available to the 270,000 Canadian patients using medical cannabis in consultation with their doctors; 
• -Alliance will conduct research into product innovation and dosing, and enhance healthcare professionals and patient education specifically in the medical cannabis field.

Ver.

Sandoz / Novartis y la marijuana (no "combustible")...

Sandoz Canada today announced that it has finalized its collaboration agreement with Tilray, a Health Canada licensed producer of medical cannabis, allowing Sandoz Canada to become the first Canadian pharmaceutical company to enter the medical cannabis field. 
The alliance will support the rising interest in medical cannabis1 by providing patients with medical treatment options of stringent manufacturing standards that are adapted to their medical conditions, advocating for broader access to products, and increasing product innovation, research and education.

Eight Sandoz and Tilray co-branded non-combustible medical cannabis products are currently available from Tilray through Health Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR), including cannabis capsules and ingestible oils. Sandoz will not work in the soon-to-be legalized recreational combustible cannabis area.

“As a leading patient-focused company, Sandoz Canada is committed to discovering new ways to improve and extend the lives of Canadians by increasing access to life enhancing medications, said Michel Robidoux, President and General Manager, Sandoz Canada. 
“As such, we have taken this innovative approach and significant step forward to be the first Canadian pharmaceutical company to support access to medical cannabis for patients and their physicians who have determined that medical cannabis is an effective option for their health conditions.” (Más)

Medical Cannabis in Canada

"In the future, we will be able to leverage Sandoz’s substantial sales force, which is something we could not build up on our own. Furthermore, our collaboration will involve the development of new product formulations.  

Sandoz already has the expertise to develop sprays, patches and many other form factors, and we have started thinking about what will be possible to develop for the Canadian and global market."

Brendan Kennedy

Tilray’s founder and CEO

  Ver también:

USA: FDA aprueba EPIDIOLEX primer cannabinoide

USA: FDA aprueba EPIDIOLEX primer cannabinoide

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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)

Una docena de blockbusters para 2018...

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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)

Argentina: Discusión sobre uso de medicamentos a base de cannabis en Congreso nacional.

Especialistas, representantes de entidades que fomentan su uso y diversos profesionales realizarán una jornada de debate hoy, en la cámara de Diputados, donde reclamarán que se aprueben algunos de los proyectos que legalizan los tratamientos a base de esta droga. 

Cada vez con mayor fuerza, diversos sectores insisten en discutir la utilización de algunos medicamentos a base de cannabis. Desde que salieron a la luz casos de niños afectados por graves convulsiones, que ahora viven mucho mejor con el aceite a base de marihuana, se aceleró el debate sobre los efectos médicos de estos productos, un amplio abanico de tratamientos que van desde potentes analgésicos a productos contra las nauseas. Luego de una serie de jornadas de discusión, que tuvieron lugar en diversas partes del país, el reclamo por la legalización llega hoy al Congreso. Será en una jornada de debate, donde abogados, médicos, y miembros de organizaciones sociales expondrán sus argumentos para que se aprueben algunos de los proyectos en danza respecto a estos fármacos. 

Desde las 11 de la mañana, en la comisión de Salud de la cámara de Diputados, se presentarán investigaciones, estudios y experiencias para comenzar el debate sobre proyectos de ley que planteen la despenalización del uso medicinal del cannabis. “La regulación del uso medicinal de esta planta es, en muchos casos, imperioso y hasta urgente, ya que hablamos de patologías para las que el cannabis es la única herramienta que encontraron las personas para sentirse mejor y hasta salvar vidas", sostuvo Sebastián Basalo, director de la revista THC especializada en temas relacionados al cannabis, políticas de drogas y reducción de riesgos y daños. En este sentido, explicó que "los dolores neuropáticos, físicos o los producidos por la quimioterapia les hace insoportable la vida a muchos pacientes, en estos casos el cannabis demostró muchísima eficacia, incluso más que las medicinas habituales". 

Lo más importante es que "se permita su uso" y que se apruebe un proyecto de ley que "garantice el acceso al cannabis medicinal para todos; la importación y que, a su vez, fomente la producción nacional ya que tenemos los profesionales adecuados y tendría costos más bajos", señaló. 

Es fundamental que, de aprobarse alguno de los proyectos, se establezca "la obligación del Estado de generar campañas de concientización sobre la disponibilidad de una alternativa natural ante los medicamentos sintéticos; así como también del uso y el cultivo", apuntó Basalo. 

El aceite de cannabis es la forma de administración más conocida y cuyo efecto "mas tiempo dura en el organismo, por lo que rinde más", explicó el especialista. "Hay chicos que padecen hasta 400 convulsiones por día, por epileposia reflactaria, muchos padres notaron que el aceite no sólo mejora la calidad de vida sino que hasta incluso hay casos en los que las salva", agregó Basalo. Y aseguró que: "El estado debe difundir y capacitar sobre el cultivo, la producción (del aceite) y lo más importante formar a los médicos para que las recete. En nuestro país los médicos son cómplices de la prohibición del cannabis medicinal". 

En la actualidad, algunos de los medicamentos a base de cannabis aprobados circulan por países europeos. Uno de ellos es el Marinol, el cual se recomienda para controlar náuseas y vómitos en pacientes de cáncer que están en tratamientos contra el cáncer, como quimioterapia. Además se utiliza para estimular el apetito en pacientes de cáncer o Sida y como análgesis para tratar el dolor neuropático de la esclerosis múltiple. 

Además, el Cesamet, también controla náuseas y vómitos en pacientes que están bajo tratamiento de cáncer.

Ver: 
Pharma gets high returns on 'pot pills'


En tanto, en vías de aprobación se encuentra el Sativex, extracto del cannabis en forma de aerosol que contiene dos componentes de la planta. 
El mismo se recomienda para tratar la espasticidad muscular y el dolor en pacientes con esclerosis múltiple, así como analgésico en pacientes con cáncer que padecen de dolor moderado a severo.

Ver:
Sativex en PHARMACOSERIAS

Además, existe un nuevo medicamento para combatir la epilepsia a base de marihuana, el cual tiene grandes posibilidades de llegar al mercado después de sus "exitosas pruebas clínicas", informa la prensa británica. Epidiolex, que así se llama el nuevo fármaco, se está ensayando en niños con el síndrome de Dravet y otras formas de epilepsia, y que no responden a los medicamentos comunes.
(Mas: Mirada profesional)

GW Pharmaceuticals dobla su valor gracias al cannabis (Epidiolex)

An experimental cannabis-based drug from GW Pharmaceuticals has successfully treated children with a rare form of epilepsy, sending the company’s shares soaring and more than doubling its stock market value.

GW said a clinical trial showed its Epidiolex drug had significantly reduced seizures in patients with Dravet syndrome, a type of epilepsy for which there are currently no treatments approved in the US, compared to a placebo. 
In the trial of 120 patients, those taking Epidiolex saw a reduction of monthly convulsive seizures of 39% compared with 13% for a placebo, which GW said was highly statistically significant. The company’s chief executive Justin Gover said: 

 "The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first [US Food and Drug Administration] approved treatment option specifically for Dravet syndrome patients and their families"

The study is the first of four epilepsy trials, and GW now plans to ask for a meeting with the FDA to discuss its plans to seek regulatory approval for the treatment. 

GW was founded in 1998 to explore the medical benefits of cannabis, and its multiply sclerosis treatment Sativex now has approval in more than 20 countries, although not in the US. The company has a UK government licence to grow cannabis plants for medical use.

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News of the successful Epidiolex trial has pushed its shares up 123% to 481.75p.