Boston, MA 06/18/2014 (wallstreetpr) – GW Pharmaceuticals PLC-ADR (NASDAQ:GWPH), a company engaged in the commercialization of a cannabinoid prescription medicines range, announced that its preliminary data on Epidiolex provided promising efficacy signals in children with epilepsy treatment-resistant that includes Dravet syndrome patients. The stock market greeted this news by taking the stock to a year high on Tuesday. However, the stock is trading down in the pre-market activity on Wednesday.
Epidiolex
The company disclosed that a high proportion of patients have shown a reduction in frequency seizure of over 50% and a part of these patients were said to be seizure-free at the close of the 12 weeks treatment. This allows the company to advance Epidiolex to the next stage of a formal development program. GW Pharmaceuticals PLC-ADR (NASDAQ:GWPH) is looking forward to commencing a Phase 2/3 clinical study of Epidiolex in Dravet syndrome during the second half of 2014.
Available data of 27 patients indicated that two of them have already started treatment in 2013 with the balance 25 patients commencing treatment during the first quarter of the current year. The data on treatment effect were calculated based on the Food and Drug Administration’s or FDA’s endpoint recommendations for efficacy evaluation that compares percentage change in the average four week frequency seizure right through the 12-week treatment to frequency seizure in a four-week baseline period. A similar approach has also been used by the company in a responder analysis.
Market For Epidiolex
GW Pharmaceuticals PLC-ADR (NASDAQ:GWPH) said that there is massive unmet need of adult and pediatric treatment-resistant syndromes of epilepsy affecting about 750K Americans. Some of the severe epilepsy syndromes found in children were Dravet and Lennox-Gastaut where seizure frequency often persists in spite of more doses of multiple anti-epileptic drugs.
Commenting on the company’s epidiolex data, Neurology Professor Orrin Devinsky said that the first open-label trial with Epidiolex has offered encouraging results. He indicated that the medication was well tolerated and some children have demonstrated reductions in seizures.
As a result of the favorable news, shares of GW Pharmaceuticals PLC-ADR (NASDAQ:GWPH) reached a year high of $91.10 during the intra-day trading on Tuesday. However, the stock is trading down over 7% in the pre-market activity on Wednesday.
