Flamel Technologies (NSDQ:FLML) said today that the 1st patient in its Rest-On phase III clinical trial was dosed with FT218, sodium oxybate, for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.The Lyon, France-based company developed the controlled-release oral formulation of sodium oxybate using its Micropump technology.
The randomized, double-blind trial has enrolled 264 patients to assess the safety and efficacy of a once nightly dosage of the oral suspension of sodium oxybate. The study will be conducted at 50-60 sites throughout the U.S., Europe and Canada, according to Flamel.
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