Flamel Technologies SA initiates Rest-On Phase III clinical trial of FT 218 to treat cataplexy in patients with narcolepsy.
Flamel Technologies SA announced that the first patient has been dosed in its Rest-On Phase III clinical trial of FT 218, 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.
REST-ON study 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 � 60 clinical sites throughout the U.S., Europe and Canada.
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