Flamel Technologies SA announced that the first patient has been dosed in its Rest-On Phase III clinical trial of FT218, a once-nightly formulation of sodium oxybate utilizing the company’s proprietary Micropump technology, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.
Mike Anderson, Flamel CEO, says in a release, “This is an exciting milestone for Flamel. FT218 is our most important asset and has the potential to provide a number of benefits to narcoleptic patients, who suffer from debilitating quality of life issues. We are seeing significant interest in this trial from both physicians and patients alike, and are excited to continue the screening and enrollment process as more sites are initiated throughout Europe, Canada and the US.”
REST-ON is a 264 patient, double-blind, randomized, placebo controlled Phase III clinical trial to assess the efficacy and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The study will be conducted across 50 to 60 clinical sites throughout the United States, Europe, and Canada.