GW Pharmaceuticals plc (GWPH - Free Report) announced that it has selected infantile spasms (IS) as the fourth target indication for the development of its lead cannabinoid candidate, Epidiolex. The company expects to initiate a two-part pivotal phase III study in the fourth quarter of fiscal 2016.
We note that Epidiolex is currently in phase III development for the treatment of a number of rare pediatric epilepsy disorders – Dravet syndrome, Lennox-Gastaut syndrome (LGS) and tuberous sclerosis complex (TSC). While positive data from the first phase III study in Dravet syndrome was announced in Mar 2016, first phase III study results in LGS are anticipated this month.
Additionally, GW Pharma announced that the FDA has granted orphan drug status to Epidiolex for the treatment of IS. Under the Orphan Drug Act, the FDA usually grants orphan drug status to drugs that are being developed for the treatment of a rare disease or condition affecting less than 200,000 patients in the U.S.
Per the company’s press release, every year there are about 2,000 to 4,000 new cases of IS in the U.S. and is usually associated with poor long-term overall prognosis. Considering the lack of treatment options for children suffering from IS, successful development and subsequent approval of Epidiolex will be a huge boost for both the eligible patient population and the company.
Epidiolex also enjoys orphan drug status from the FDA for the treatment of Dravet syndrome, LGS and TSC. Additionally, GW Pharma has received Fast Track status from the FDA and orphan status in the EU for Epidiolex for the treatment of Dravet syndrome.
Apart from Epidiolex, GW Pharma is evaluating additional development programs in other orphan pediatric seizure disorders.
GW Pharma currently is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Retrophin, Inc. (RTRX - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).
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