033 Effects of Alcohol Administered with Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single Dose, Seven-Way Crossover Study

Abstract

Flibanserin is a serotonin 5-HT1A agonist and a 5-HT2A antagonist approved in the US and Canada for the treatment of HSDD in premenopausal women. Upon approval in the US, the FDA requested several postmarketing requirements, including an alcohol interaction trial. The purpose of this trial was to evaluate the safety of concomitant administration of flibanserin with relevant concentrations of ethanol due to concerns about the increased risk of severe hypotension and syncope. This postmarketing study was primarily designed to evaluate the pharmacodynamic effect of flibanserin 100 mg co-administered with varying doses of ethanol on dizziness, syncope, and hypotension in healthy premenopausal women. In this single-center, randomized, double-blind, single-dose crossover study, participants were randomly assigned to 1 of 12 sequence groups to receive each of 7 treatments: flibanserin 100 mg or placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or flibanserin 100 mg only. The primary endpoint was the proportion of subjects who experienced dizziness, syncope or hypotension. Secondary endpoints included subject’s self-assessment of drowsiness by a 100 mm visual analog scale (VAS). Safety endpoints included orthostatic vital signs. In compliance with the study site’s standard operating procedures, subjects were not permitted to stand for measurement of orthostatic vital signs if their supine blood pressures were <90/40 mmHg, or if they exhibited symptoms of possible hypotension after dosing.