Addyi (flibanserin) is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist.
Addyi is specifically indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty.
Addyi is supplied as a tablet for oral administration. The recommended dosage is 100 mg taken once daily at bedtime. Addyi should be dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression. Discontinue treatment after 8 weeks if no improvement is observed.
The FDA approval of Addyi was based on three 24- week, randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3). The three trials included premenopausal women with acquired, generalized HSDD of at least 6 months duration. In the clinical trials, acquired HSDD was defined as HSDD that developed in subjects who previously had no problems with sexual desire. Generalized HSDD was defined as HSDD that was not limited to certain types of stimulation, situations or partners. The subjects were treated with Addyi 100 mg once daily at bedtime (n = 1187) or placebo (n = 1188). These trials each had two co-primary efficacy endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire:
The change from baseline to Week 24 in the number of monthly SSEs (i.e., sexual intercourse, oral sex, masturbation, or genital stimulation by the partner). The SSEs were based on patient responses to the following questions: “Did you have a sexual event?” and “Was the sex satisfying for you?”
Studies 1 and 2 had a different sexual desire endpoint than Study 3:
In all three trials, Addyi resulted in statistically significant improvement compared to placebo in the change from baseline in monthly SSEs at Week 24. In Study 1 and 2, there were no statistically significant differences between Addyi and placebo for the eDiary sexual desire endpoint (change in baseline to Week 24). In contrast, in Study 3 there was statistically significant improvement in the change from baseline to Week 24 in sexual desire (using the FSFI Desire Domain) with Addyi compared to placebo.
Adverse effects associated with the use of Addyi may include, but are not limited to, the following:
Addyi comes with a boxed warning label:
Addyi (flibanserin) is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.
For additional information regarding Addyi or generalized hypoactive sexual desire disorder, please visit http://www.addyi.com/