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Despite extensive research documenting the efficacy of cannabis in the treatment of epilepsy, there has not yet been any cannabis-based anti-epileptic drug introduced into the US pharmaceutical market – up to # 39 at this week.
On Monday, the US Food and Drug Administration approved an anti-epilepsy drug using plant-derived cannabidiol (CBD), a common non-psychoactive cannabinoid found in the plant Cannabis sativa. This is the first time that the regulator has lit up a natural CBD drug – not synthesized – and some experts hail this endorsement as a big step forward for the medical cannabis industry. .
"It's fantastic, it was a complete tipping point," said George Scorsis, CEO of Liberty Health Sciences, the US subsidiary of Aphria, Inc., a Canadian medical cannabis firm. "He quickly destigmatizes what cannabis can do."
Epidiolex, manufactured by the GW Pharmaceuticals company, owned by the United States, targets two forms of severe epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. These rare diseases are often difficult to treat because they are resistant to most anti-epileptic drugs.
That's why GW Pharmaceuticals is delighted with the FDA's approval, says Steve Schultz, vice president of investor relations at GW Pharmaceuticals. Clinical trials show that Epidiolex significantly reduces the frequency of seizures – patients under Dravet saw a 39% decrease in seizures, while people with LSG experienced a 37 to 41% decrease in seizures. Epilepsy, depending on the dosage.
"Patients who suffer from these treatment-resistant epilepsies will now have an additional option that they can use," says Schultz, Rolling stone. "It's the most important face of this exciting endorsement."
The US Drug Enforcement Administration (DEA) has clbadified all cannabinoids as marijuana extracts, including CBD, as an Annex I substance, which means that the agency finds that compounds do not have no medicinal benefits . In order for Epidiolex to even be placed on the US market, the DEA should reclbadify the CBD – a process that will take at least 90 days. (This will not affect CBD derived from hemp, which is exempt from the Controlled Substances Act under the Farm Bill.)
How will the DEA reprogram this form of CBD is too early to predict, say some experts. The agency could reclbadify CBD of plant origin as a legal drug product – but do not a legal recreational drug – under Schedule II or III, while keeping cannabis an Schedule I drug. Or the DEA could completely unsubscribe cannabis – although experts consider this option much less likely. (Dozens of cannabis related
Bills float around Congress, including several that would decriminalize marijuana, but to date, none of them have the right to vote.)
"There are so many things happening in this area right now, we do not know what level they are going to go to," says Scorsis. "In the end, all that is outside of what it is today would be a big step forward for the entire industry."
Rolling stone contacted the DEA for comments, but was not re-read in time for publication.
Basically, the FDA's approval of Epidiolex validates what the public has been saying for decades, says NORML Deputy Director Paul Armentano: Cannabis has tremendous therapeutic benefits and medicinal. But, argues Armentano, the DEA's impending decision is only one variable among others that will determine the impact that Epidiolex will have in its approval. on the medical cannabis industry – if that's the case.
"People minimize these variables," says Armentano Rolling stone. "There are still many things we do not know."
Think of it this way: Federal law prohibits US-based drug companies from legally cultivating marijuana for scientific research purposes. Scientists in the United States could apply for a license to conduct research on Schedule I drugs, but it's often a complicated and frustrating process.
"That's why Epidiolex was developed in Britain," says Armentano, "because GW Pharmaceuticals has gotten approval from its federal government."
It is true that the rescheduling of CBD derived from cannabis could potentially loosen these regulations. But, according to some experts, the change would barely be enough to provoke a revolution in medical cannabis research.
In addition, Epidiolex is not the first FDA-approved CBD drug, although it is the first derivative of a plant. In the mid-1980s, the regulatory body affixed on marijuana marijuana (dronabinol) and Cesamet (nabilone), two anti-nausea and anti-vomiting pills using synthetic forms of tetrahydrocannabinol – better known as THC – the active psychoactive compound of cannabis. In 2016, the FDA approved Syndros, another synthesized cannabinoid-based drug that is used to treat AIDS-related anorexia.
The DEA had clbadified nabilone and liquid synthetic THC found in Syndros as Schedule II substances, while dronabinol is on the list of substances in Table III, according to NORML. This means that these synthesized compounds are, under the Controlled Substances Act, legal medical treatments.
Yet, experts say, none of these drugs have led to major shocks in the pharmaceutical world. "The approval of Epidiolex has no more impact on the medical cannabis industry than Marinol, especially if its use is limited to patients with pediatric epilepsy." "says Dennis Hunter, co-founder of CannaCraft, a California-based cannabis-manufacturing company.
This raises another variable: How comfortable will physicians be with prescribing Epidiolex for use not indicated on the label?
GW Pharmaceuticals' drug takes two rare and very specific epilepsies, which means that a relatively small number of people will have access to the drug. This means that the broader impact of the FDA's approval may, in part, depend on whether doctors use Epidiolex to treat other non-FDA-sanctioned diseases, experts say.
"The main area that will continue to advance the use of CBD products and the level of education in terms of how to prescribe it," says Scorsis Rolling stone.
Schultz tells Rolling stone that GW, and its US subsidiary, Greenwich Biosciences, have other CBD-based drugs under development or undergoing clinical trials that address a broader range of neurological and neurological disorders. muscle. Epidiolex, however, should only be prescribed for the two epileptic disorders for which it is approved, he says.
Then there is the price. Schultz tells Rolling stone that the company has not yet set a cost for Epidiolex, but, according to the New York Timesbadysts expect the drug to work between $ 2,500 and $ 5,000 a month. As the Time points out that it is much more money than most of the CBD therapeutic products out there.
If Epidiolex has such a high price, the drug may be out of reach for people it intends to help, says Armentano.
In the end, the implications of Epdiolex's FDA approval for the medical cannabis industry are still unclear, although state-regulated cannabis markets are likely to remain unchanged, say the experts. Rolling stone. There are just too many factors to consider.
But one thing is clear, Hunter says, "The approval of Epidiolex highlights the absurdity of clbadifying cannabis as an illegal substance."
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