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Biotech / Medical : Avadel AVDL

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From: Paul Lee10/6/2016 7:37:28 AM
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Flamel Technologies Reaches Agreement With FDA on Protocol for Phase III Pivotal Trial of FT218



October 6, 2016

LYON, FRANCE--(Marketwired - Oct 6, 2016) - Flamel Technologies ( NASDAQ : FLML ) today announced that its Irish subsidiary, Flamel Ireland Holdings, has reached agreement with the U.S. Food and Drug Administration (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 (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 (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.

Mike Anderson, Chief Executive Officer of Flamel, remarked, "We are thrilled to announce that we have come to a much anticipated agreement with FDA on our SPA for a pivotal study of FT218, Micropump® sodium oxybate. This is a major milestone for the trial, as we move forward with site initiation in Europe and subsequently, the United States. We believe our once nightly formulation of sodium oxybate has the potential to offer significant improvements over the current standard of care, in addition to meaningful improvement in overall quality of life for patients suffering from narcolepsy."
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