140 The Impact of the Timing of Alcohol Consumption on the Safety and Tolerability of Flibanserin

Abstract

Flibanserin is approved for the treatment of HSDD in premenopausal women. In a previous alcohol-interaction study where alcohol was co-administered with flibanserin, an increased incidence of hypotension and syncope was observed. This study was designed to evaluate the impact of the timing of alcohol consumption on the safety and tolerability of flibanserin in healthy premenopausal women. This was a single-center, randomized, placebo-controlled, double-blind, 4-treatment crossover study (N=64). Subjects (mean age: 32.5 + 8.7) were randomized to either flibanserin 100mg or placebo in each of 2 Treatment Periods. On days 1-3 of each Treatment Period, subjects received daily doses of study drug to achieve a steady state. Following a standardized breakfast on days 4-10, subjects consumed either 0.4g/kg of alcohol administered with orange juice or orange juice alone 2, 4, or 6 hours prior to taking study drug at 1pm. Vital signs were subsequently monitored up to 10 hours. The primary endpoint was the proportion of subjects experiencing syncope or orthostatic hypotension-associated adverse events requiring medical intervention. Secondary endpoints included the proportion of subjects with hypotension (systolic bp < 90mmHg and/or diastolic bp < 60mmHg), symptoms of dizziness, lightheadedness, or faintness that resulted in no standing blood pressure, and the rates of syncope, orthostatic hypotension, dizziness, and somnolence.