Effects of Gepirone-ER on Sexual Function in Patients With Major Depressive Disorder.

Objective: To describe effects of gepirone extended-release (ER), an azapirone, on sexual function in patients receiving treatment for major depressive disorder (MDD).

Methods: Sexual function was assessed in 1,767 patients (67% women) across five Phase 3 randomized controlled clinical trials comparing gepirone-ER against placebo or active treatment with selective serotonin reuptake inhibitors (SSRIs) for treatment of MDD. All five trials assessed sexual functioning in the short term (8 weeks), with three including long-term extensions of 16, 20, or 44 weeks. Sexual function was assessed prospectively and throughout trials via clinical interview and well-validated survey measures.

Results: Across studies, gepirone-ER was equivalent to placebo on sexual side effects and treatment-emergent sexual dysfunction. Relative to SSRIs, gepirone-ER was associated with significantly better effect on sexual function across time points studied. Evidence from patients without sexual dysfunction at baseline demonstrates superiority of gepirone-ER over SSRIs in the first few weeks of treatment, when patients are most vulnerable to the negative effects of sexual side effects on medication nonadherence/ discontinuation. Importantly, these benefits were maintained across treatment.

Conclusions: Gepirone-ER was not associated with sexual dysfunction in patients with MDD. Rates of sexual side effects and treatment-emergent sexual dysfunction with gepirone-ER were comparable to those reported for placebo and lower than sexual side effects reported for active treatment with SSRIs.