The biopharmaceutical company GW Pharmaceuticals (GWPH), along with its U.S. subsidiary Greenwich Biosciences, announced the publication of its Phase 3 study of cannabidiol oral solution in patients with Lennox-Gastaut syndrome (LGS) in The New England Journal of Medicine.
Announcing positive results, GW CEO Justin Gover hailed the study’s publication as another landmark moment for the company and touted its results as further proof of the cannabidiol’s potential in the treatment of LGS.
“We are now in the latter stages of the FDA`s review of our New Drug Application and look forward to a decision from FDA in late June,” stated Gover. “If approved, we expect to make this important potential new medicine available to U.S. patients with LGS in the second half of the year.”
In a double-blind, placebo-controlled trial conducted at 30 clinical centers, researchers randomly selected 225 patients diagnosed with LGS, with an age range of 2 to 55 years, who had two or more drop seizures per week. The patients were divided into three groups. One group comprised of 76 patients would receive a 20mg dose of Epidiolex, the company’s proprietary cannabidiol-based medicine, twice a day for two weeks. The second group, which was comprised of 73 patients, would receive a 10mg of Epidiolex twice a day for two weeks,. The third group, which had 76 patients, was given a placebo.
During the 28-day baseline observation period, the combined average of drop seizures for all groups combined was 85. After treatment, the group treated with 20mg of Epidiolex experienced a 41.9% reduction in seizures, while the group that received a 10mg does experience a 37.2% reduction. The placebo group only saw a 17.2% reduction in drop seizures. Sides effects from taking Epidiolex included drowsiness, reduced appetite, and diarrhea; all of which were more pronounced in the group taking the higher dose. A total of six patients from the 20mg group and one patient from the 10mg had to withdraw from the study due to the side effect. Additionally, 14 patients who received Epidiolex had elevated liver aminotransferase concentrations.
News of the study’s positive results has created a surge in GW’s stock price at the open only to trim those gains as the morning went on. The stock is currently trading at an all-time high of $150.68 per share. It is nearing the average analyst price target of $155.50 according to Yahoo Finance.