For first time ever, FDA approves marijuana-derived medicine

AP  File 2017		GW Pharmaceuticals’ Epidiolex a medicine made from the marijuana plant

US health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use. The actual list price of Epidiolex has not been set, but has been estimated at $2,500 to $5,000 a month, significantly more expensive than other CBD-based medication made available through state-legal medical cannabis programs.

The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.

Made by GW Pharmaceuticals, the drug treats two rare types of epilepsy using CBD, a therapeutic compound in cannabis that's not linked with a high.

"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures".

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"This is an important medical advance", FDA Commissioner Dr. Scott Gottlieb said in a statement Monday. "But it's also important to note that this is not an approval of marijuana or all of its components". The new drug is anticipated to become available to patients later this fall.

Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.

The study also showed that Epidiolex is a safe treatment, with only seven patients dropping out of the trial due to side effects - six from the 20-mg group and one from the 10-mg group.

Epidiolex is created to treat two rare forms of childhood epilepsy.

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Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. "I really don't think [the FDA approval is] going to affect us much".

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts.

Epidiolex is also the first prescription created to treat children with Dravet syndrome, according to the FDA's announcement. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. The agency is expected to make this classification within 90 days.

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The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.

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