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.
“This is an exciting milestone for Flamel,” CEO Mike Anderson said in prepared remarks. “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 U.S.”
Shares in the company rose last month after the pharmaceutical company met expectations on Wall Street with its 3rd quarter results.
Flamel posted a loss of -$22.3 million on sales of $32.1 million for the 3 months ended Sept. 30, for bottom-line growth of 20% despite a sales loss of 32% compared with the same period last year.