GW Pharma's Epidiolex Becomes First CBD To Get DEA Rescheduling

Amid the controversies surrounding the legalization of cannabis and associated products, gradual advancements have been made this year.

As of Sept. 27, a specific type of cannabidiol, or CBD oil will be federally legal in the United States.

What Happened

The U.S. Drug Enforcement Administration announced plans to classify Epidiolex, the oral solution of pure plant-derived CBD, as a Schedule V drug, legal in the U.S. Epidolex was formerly classified as a Schedule I substance, along with heroin, cannabis and ecstasy.

Epidiolex has a tendency of firsts. After becoming the first FDA-approved cannabinoid-based therapy, it will now be the first drug of its kind to launch domestically, and would aid in treating Dravet and Lenox-Gastaut syndromes, as well as other seizure symptoms. These ailments affect roughly 20,000 U.S. patients.

Why It’s Important

Schedule V is classified as “drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes.”

Other drugs within this schedule are Lomotil, Motofen, Lyrica and Parepectolin. This new classification is lower than originally anticipated, as earlier plans demonstrated a Schedule IV ranking, with drugs such as Xanax, Ambien and Tramadol.

The new schedule ranking will allow for more exposure to the treatment and more approved research pertaining to the medical cannabis industry as a whole.

What’s Next

New Cannabis Ventures founder and author of the 420 Investor Alan Brochstein commented on the news.

"There was some concern about a slight delay and the remote possibility of a snafu," Brochstein told Benzinga. "Great news, but expected for the most part. Now, it's game on for the company."

Cantor Fitzgerald analyst Elemer Piros reiterated an Overweight rating and $211 price target for GW Pharma.

“With this final box checked off, GW Pharmaceuticals will prepare for the U.S. launch within the next six weeks," Piros wrote in a note. "During the last earnings call, the company announced it had completed the hiring of the U.S. sales team, with two national directors, eight regional managers, and 66 neurology account managers to target ~5,000 total physicians.”

GW Pharmaceuticals Plc. GWPH shares surged 6.4 percent to $173.63 at time of publication.

Related Links:

Morgan Stanley: DEA Likely To Reclassify GW Pharma's Cannabinoid Therapy For US Launch

Why GW Pharma's Epidiolex Results Could Shape The Future Of Cannabis-Based Therapeutics