The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.
Several researchers are studying the potential of CBD to treat psychiatric conditions.
Based on the potential for abuse, the Drug Enforcement Administration (DEA) categorizes chemicals into five schedules, with Schedule 1 substances - like marijuana and heroin - considered the most deadly and deemed to have no medical benefits.
"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters. Epidiolex, which is produced by the United Kingdom-based company GW Pharmaceuticals, is meant to treat two forms of rare childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio. Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months. 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.
"Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality and most importantly, that these products have been proven safe and effective for patients", Gottlieb added.
The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. United Kingdom -based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis created to maximize a therapeutic component while minimizing components that produce euphoria.
Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved drugs.
The company has not said how much the drug will cost, but Wall Street analysts have predicted it could cost $25,000 per year.
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 was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision. Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.
The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.