Flamel reaches agreement with FDA on FT218 Phase III pivotal trial protocol
Flamel Technologies announced that its Irish subsidiary, Flamel Ireland Holdings, has reached agreement with the FDA for the design and planned analysis of a Phase III clinical trial of FT218, a once nightly formulation of sodium oxybate utilizing the Company's proprietary drug delivery platform, Micropump. The agreement was reached through the Special Protocol Assessment, or SPA, process. A SPA is an acknowledgement by FDA that the design and planned analysis of the company's pivotal clinical trial of FT218 adequately addresses the objectives necessary to support a regulatory submission. The Phase III trial, titled "A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension, or FT218, for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy," recently commenced patient enrollment in Canada, with sites in Europe and the U.S. to be initiated near-term.