The company released positive results for its first Phase 3 pivotal study for Epidiolex on Monday.
Investors have undoubtedly noted the surge in focus on marijuana companies these past few years. With many US states moving to legalize marijuana, and medicinal uses of cannabis on the rise, an incredible number of companies have come out of the woodwork.
Of those companies, there is one that’s ahead of the crowd, and most certainly ahead of the curve. GW Pharmaceuticals (NASDAQ:GWPH) released positive results for its first Phase 3 pivotal study for Epidiolex on Monday, and the results sent its share price through the roof.
In the study, Epidiolex “achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo.” The company’s study of Epidiolex in relation to Dravet syndrome is the first of four Phase 3 epilepsy trials for the drug, and GW hopes its study will confirm the therapeutic benefits of cannabinoids.
Founded in 1998, GW is developing a portfolio of cannabinoid prescription medicines that meet patient needs in a wide range of therapeutic indications. Epidiolex is a liquid formulation of pure plant-derived cannabinoid that is targeting various orphan pediatric epilepsy syndromes. The company been granted an Orphan Drug Designation for Epidiolex from the US Food and Drug Administration (FDA) for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. The drug also has a Fast Track Designation from the FDA.
Dravet syndrome is rare genetic epileptic dysfunction of the brain that is found in infants. Currently, there are no FDA-approved treatments for Dravet symdrome.
“Dravet syndrome is one of the most catastrophic types of epilepsy in children and safe and effective treatments are desperately needed,” said Mary Anne Meskis, executive director of the Dravet Syndrome Foundation.
GW’s Phase 3 study involved 120 patients, some of whom were given the drug; others were given a placebo to be taken with their existing medication over the course of 14 weeks. Results show that there was a 39-percent reduction in the frequency of seizures in patients taking Epidiolex vs. 13 percent in those taking the placebo.
What does this mean for cannabinoid-based products?
If GW can prove that Epidiolex works, it could become the first drug of its kind to be approved by the FDA.
“The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy,” said Orrin Devinsky, the company’s managing director, in a press release.
At the end of trading on Monday, GW’s share price had more than doubled, spiking 120.25 percent to end the day at $84.71.
Securities Disclosure: I, Vivien Diniz, hold no direct investment interest in any of the companies mentioned in this article.