London, England – The GW Pharmaceuticals (NASDAQ: GWPH) announced Monday a successful Phase 3 trial for the drug Epidiolex. The medication is a cannabidiol product that has proven to reduce the number of seizures in patients with Lennox-Gastaut syndrome (LGS). In March, GW Pharmaceuticals also revealed positive results in patients with Dravet syndrome.
The LGS, like Dravet syndrome, is a rare and severe type of childhood-onset epilepsy. The LGS syndrome produces different types of seizures, especially tonic and atonic, that cannot be treated with regular seizure medication.
The syndrome is usually detected around ages 3 to 5 years, and it can be caused by brain malformations, severe head injuries, inherited degenerative or metabolic conditions, or central nervous system infections. However, in about a quarter of children, the cause has not been identified.The disease can persist through childhood and adolescence to adult years. This condition can also affect intellectual development, the Epilepsy Foundation says.
GW Pharmaceuticals is a biopharmaceutical company that seeks to discover, develop and sell medications based on its proprietary cannabinoid product platform, GlobeNewswire reports. Medscape says on its website that Epidiolex comes in a liquid presentation of pure plant-derived cannabidiol, which is a non-psychoactive component of the cannabis plant. The Phase 3 clinical trial of its medicine Epidiolex, is a first randomized, double-blind, placebo-controlled trial to treat LGS.
The study consisted of 171 randomized patients between ages 2 to 55 years with a confirmed diagnosis of drug-resistant to one or more concomitant antiepileptic drugs. The average age for the trial was 15 years old, and 34 percent were 18 years and older.
The study was divided into two groups: 85 patients received an antiepileptic drug-placebo and the other 86 received 20mg/kg/day of Epidioplex.
The Phase 3 trial median baseline drop-seizure frequency per month was 74. Drop seizures involved the entire body, trunk or head that lead or could lead to a fall. Also, the drop seizures were defined as a tonic, atonic, and tonic-clonic. MedScape reports.
Treatment with Epidiolex had a median reduction of 44 percent in monthly drop seizures against the placebo treatment that only had a decrease of 22 percent. It had positive results: 86 percent of the patients receiving Epidiolex did not experience side effects. But 69 percent of patients receiving an antiepileptic drug as placebo suffered adverse effects.
According to GlobeNewswire, only 10 percent of the people on the drug’s group experienced the most common Epidiolex side effects, which were: somnolence, diarrhea, decreased appetite, vomiting, and fever. But 20 patients did experience severe adverse events compared to four patients on placebo. Twelve of those patients had to stop the Epidiolex treatment against one patient on placebo.
GW company is conducting a second Phase 3 trial, based on dose-ranging, for the treatment of Lennox-Gastaut syndrome. This second phase enrolled 225, and it will be divided into three new groups. One group will receive the same doses of Epidiolex as the group in the first trial (20 mg/kg/day), the second group will be given a reduced dose of 10mg/kg/day, and the third one other antiepileptic drugs as placebo.
Further data regarding the studies will be presented in future publications and medical meetings, GlobeNewswire says.
Source: Globe Newswire