Jun 09 2019
Flamel Technologies Announces Positive Results of a First-in-Man Clinical Trial With Micropump Sodium Oxybate
h in Blogs
Potential Elimination of the “Middle-of-the-Night Dose” Achieved; Current Study Continues to Allow for More Information on Higher Doses
LYON, FRANCE – Apr 7, 2014 – Flamel Technologies (NASDAQ: FLML) today announced that its First-in-Man (FIM) clinical study in healthy volunteers using its proprietary Micropump® technology applied to sodium oxybate has identified formulations that demonstrate the potential to eliminate the second nighttime dose for patients suffering from narcolepsy. The current dosing regimen for the standard of care, Xyrem® (sodium oxybate), in the United States is two equal, divided doses: the first dose at bedtime and the second dose 2.5 to 4 hours later. The elimination of the second dose for narcolepsy patients would not only provide more convenience, but may improve the benefit sodium oxybate provides as there will be no disruption to nighttime sleep. The potential for additional benefits, including improved safety, will be studied.