Flamel Technologies' Irish subsidiary, Flamel Ireland Holdings, has reached agreement with the US 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.
Flamel CEO Mike Anderson said: "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."
About Sodium Oxybate
Sodium Oxybate is the sodium salt of gamma hydroxybutyrate, an endogenous compound and metabolite of the neurotransmitter gamma-aminobutyric acid (GABA).
It has been described as a therapeutic agent with high medical value; in Europe and the United States it is currently approved in a twice nightly formulation indicated for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy at doses up to 9g/night.
Micropump is a microparticulate system that allows the development of modified and/or controlled release of solid, oral dosage formulations of drugs.
Micropump allows the achievement of extremely precise pharmacokinetic profiles of single or combination of drugs, in a variety of formats (such as tablets, capsules, sachet, or liquids (LiquiTime), while preserving the targeted release rate over the shelf-life of the product.