This Cannabinoid Prescription Medicines Company Surged 15%: Here’s Why
GW Pharmaceuticals (NASDAQ: GWPH), a United Kingdom-based pharmaceutical company that focuses on developing and commercializing therapeutics from its proprietary cannabinoid product platform, surged higher by more than 15 percent on Monday.
GW announced it has achieved positive results in its second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
GW said that in its trial, patients who were given 20mg/kg/day of Epidiolex in addition to their current treatment saw a median reduction in monthly seizures of 42 percent. By comparison 17 percent of patients who were given a placebo to supplement their existing medication saw only a 17 percent improvement.
Similarly, patients who were given 10mg/kg/day of Epidiolex saw their monthly seizures drop by a median of 37 percent, compared to 17 percent who took a placebo.
The study consisted of 225 patients aged 2 through 55 with participated in the study Among the patients enrolled in the Phase 3 trial, 99 percent have opted to continue into an open-label extension trial. The company will communicate with the investment community further data in future publications and medical meetings.
GW’s announcement marks the second set of positive results in its Phase 3 trial of Epidiolex. Accordingly, the company plans on submitting a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2017.
“The positive outcome in this second trial of Epidiolex in patients with Lennox-Gastaut syndrome demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy,” stated Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center and principal investigator in the trial. “The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy.”
GW’s positive announcement helped boost shares of other pharmaceutical companies that explore and commercialize cannabinoid therapies.
For example, shares of Zynerba Pharmaceuticals (NASDAQ: ZYNE) gained more than 10 percent on Monday. The company’s ZYN002 is being explored in a Phase 2 STAR-2 trial.