Altasciences conducted novel endpoint research to determine the extent of next-day impairment of Flibanserin in cognition and alertness.
A randomized, double-blind, placebo-controlled, four-way crossover study was performed to evaluate the potential next-morning residual effects after bedtime dosing in 72 healthy premenopausal women. Treatment arms included a placebo administration group, a positive control zopiclone group, and two separate dosage groups of Flibanserin, which included 100 mg qhs or 200 mg qhs. Assessments were based on simulated driving, a Symbol Digit Coding Test (SDCT), and the Karolinska Sleepiness Scale (KSS).
Bedtime administration of Flibanserin (up to 200 mg) did not impair next-day cognitive function or driving performance, while improving symptoms of HSDD.
Altasciences was able to demonstrate that there was no impairment to driving the morning after nighttime dosing of Flibanserin in premenopausal women. The study was described as “reassuring” by the FDA.