The FDA May Approve Its First Cannabis-Based Drug This Week

The FDA May Approve Its First Cannabis-Based Drug This Week

Schedule 1 substances such as marijuana and heroin are considered to be the most deadly, and deemed to have no medical benefit at all.

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use. The CBD oil derived from the marijuana plant has been administered to relieve insomnia, anxiety and chronic pain, as well as to treat multiple sclerosis and Parkinson's disease, among conditions, wrote Harvard Medical School professor Dr. Peter Grinspoon.

The Drug Enforcement Administration (DEA) classifies marijuana or cannabis as a Schedule 1 substance - which means there is "no now accepted medical use and a high potential for abuse".

The FDA signed off on the use of Epidiolex, a drug from Britain's GW Pharmaceuticals, to treat two kinds of epilepsy.

"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life", said Doctor Billy Dunn, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in a statement accompanying a press release. Epidiolex contains only cannibidiol, one of hundreds of molecules found in the marijuana plant, and treats only two extremely rare forms of pediatric epilepsy affecting less than 45,000 children. The Drug Enforcement Administration is expected to reclassify CBD, allowing prescriptions of Epidiolex.

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems. "We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high-quality products".

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.

Some experts believe the anticipated approval will likely open the floodgates for product demand of other CBD products, and place further pressure on the FDA to move it along and approve other CBD-based medications.

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. "I really don't think it's going to affect us much".

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued. British drugmaker GW Pharmaceuticals expects the oral solution to hit the market this fall.

A reclassification is expected within 90 days, according GW Pharmaceuticals.

"This is clearly a breakthrough drug for an very bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.

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