Before Tilray (TLRY) and Canopy Growth (CGC) took over cannabis stock portfolios, GW Pharmaceuticals plc (Nasdaq: GWPH) was the darling of the group. However, the recent positive news from this cannabis biotech company’s epilepsy study serves to remind investors that great good comes from cannabis research.
On Monday, GW Pharma announced positive top-line results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of Epidiolex in the treatment of seizures associated with Dravet syndrome, a rare and severe form of childhood-onset epilepsy. The biotech company reported that in this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint of reduction in convulsive seizures for both dose levels (10 mg/kg per day and 20 mg/kg per day) with high statistical significance compared to placebo. The company said that both doses also demonstrated statistically significant improvements on all key secondary endpoints.
“The positive outcome in this second trial of Epidiolex in patients with Dravet syndrome further reinforces the effectiveness of this newly available medicine in this particularly difficult to treat, childhood-onset epilepsy,” stated Ian Miller, M.D., Director, Epilepsy and Neurophysiology Program at Nicklaus Children’s Hospital in Miami, FL and principal investigator of the trial. “The totality of data from the controlled clinical trials completed for Epidiolex have shown clinically meaningful seizure reductions and a consistent safety and tolerability profile.”
The drug was recently approved by the FDA and given a classification as a schedule five drug in September. Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.
“The positive results from this trial follow the recent FDA approval, DEA rescheduling and U.S. launch of EPIDIOLEX for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut Syndrome in patients two years and older. These data show an effective dose range in Dravet syndrome that is consistent with our FDA approved label, and which allows for dosing flexibility to address individual patient needs,” stated Justin Gover, GW’s CEO.
The average age of the patients in the study was nine years. The patients were having approximately 12 convulsive seizures a month and approximately 35 total seizures per month. On average, patients were taking three anti-epileptic drugs (AED), having previously tried and discontinued on average, four other AEDs.