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April 7, 2014
07:36 EDTFLMLFlamel announces positive results of FIM clinical trial with Micropump
Flamel Technologies announced that its First-in-Man, or 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 achieved the objective of one single dose before bedtime for patients suffering from narcolepsy, eliminating the need for a second dose. The current dosing regimen for the standard of care, Xyrem, 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.
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