Market Overview

GW Pharma's Epidiolex Hits Phase 3 Primary Endpoint For Treating Lennox-Gastaut Syndrome

GW Pharma's Epidiolex Hits Phase 3 Primary Endpoint For Treating Lennox-Gastaut Syndrome

GW Pharmaceuticals plc (NASDAQ: GWPH) revealed Epidiolex has achieved primary endpoint in treating Lennox-Gastaut syndrome. The positive results came from its randomized, double-blind and placebo-controlled final stage clinical study.

Earlier in June, the company disclosed favorable results from its first pivotal phase three study of Epidiolex for the treatment of seizures in connection with LGS. Similarly, in March too, the company released positive results in connection with Dravet syndrome.

Therefore, GW Pharmaceuticals expect to file a NDA to the FDA in the first half of next year.

Related Link: GW Pharmaceuticals Takeover Talk 'Seems A Bit Premature'

President and CEO of the Epilepsy Foundation, Philip Gattone, said, "We feel a tremendous sense of urgency to stop seizures, and believe that the pursuit of new therapies offers hope to individuals who have no currently available therapy to effectively stop their seizures. The Epilepsy Foundation will continue to be a champion for GW's efforts to pursue this innovative new therapy as studies progress."

The drug maker viewed that Epidiolex was well tolerated during the trial period. The adverse pattern of events was in line with the previously reported two Phase 3 studies. The company pointed out that one patient on 10mg/kg Epidiolex discontinued treatment citing an adverse event compared with six patients on 20mg/kg and one patient on placebo.

Following the news, the stock jumped $11.48, or 10.67 percent, to $119.07 in the pre-market trading on Monday.


Related Articles (GWPH)

View Comments and Join the Discussion!

Posted-In: EpidiolexBiotech News FDA Movers Trading Ideas General Best of Benzinga