– Orphan Drug Designation Granted from FDA for Epidiolex for the Treatment of IS –
– Phase 3 Trial Expected to Commence in Q4 2016 –
LONDON, June 21, 2016 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the Company has selected infantile spasms (IS) as the fourth target indication for its Epidiolex orphan pediatric epilepsy development program. In addition, the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Epidiolex (cannabidiol or CBD) for the treatment of IS. GW expects to commence a two-part pivotal Phase 3 study in the fourth quarter of 2016.
Epidiolex is already being developed in three other orphan indications within the field of pediatric epilepsy – Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous
... read more at: http://www.globenewswire.com/news-release/2016/06/21/850173/0/en/GW-Pharmaceuticals-Announces-New-Planned-Epidiolex-Cannabidiol-or-CBD-Development-Program-in-Infantile-Spasms-IS.html