Sodium oxybate delivered via Micropump technology: Clinical trial data

Flamel reported data from a crossover trial in 14 evaluable healthy volunteers showing that sodium oxybate delivered with Flamel's Micropump drug delivery technology at a nightly dose of 4.5 g could eliminate the need for a second nighttime dose in patients with narcolepsy. The current dosing regimen for standard of care (SOC) for patients with narcolepsy with Xyrem sodium oxybate in the U.S. is the first dose at bedtime followed by a second dose 2.5-4 hours later. The trial showed that Micropump sodium oxybate had an onset of action that was similar to Xyrem and a peak plasma concentration (Cmax) that was lower than Xyrem. Additionally, mean blood concentration of sodium oxybate at hours 7 and 8 were similar between treatment groups. Flamel said the study will now evaluate higher doses of Micropump sodium oxybate. ...