Orenetide for the treatment of hypoactive sexual desire disorder: results of a randomized placebo-controlled trial

Hypoactive desire disorder (HSDD) is characterized by a distressing and prolonged deficiency of sexual desire. Currently, despite the high prevalence of HSDD in women, the potential of drug treatment for this problem is limited: there are only two pharmacologic treatments both with modest efficacy, approved in a limited number of countries. Desirix (INN Orenetide) - is an innovative peptide drug developed in Russia to restore sexual desire and concomitant functions in women with HSDD. Aim: This study aimed to conf irm the safety and eff icacy of Desirix (INN Orenetide) in premenopausal women with HSDD. Materials and methods: This randomized, double-blinded, placebo-controlled, multicenter, 12-week Phase III clinical trial in parallel arms was conducted at 19 sites within the Russian Federation (Russian CTA #688 dated 25.12.2017; ClinicalTrials.gov NCT03463707). The study enrolled 189 premenopausal women with diagnosed Lack or loss of sexual desire (ICD-10 code F52.0; equivalent to acquired generalized HSDD according to DSM-IV), aged 21-50 years. Participants were eligible if they had a regular menstrual cycle and low sexual desire for at least 24 weeks prior to screening. After 4 weeks of baseline assessment (screening period) participants were randomly assigned to receive Desirix (Orenetide, development code BP101) 2 mg/day nasal spray or identical placebo. 95/189 (50,3%) participants were randomized to Desirix (Orenetide) treatment arm, and 94/189 (49,7%) to placebo arm. After 4-weeks daily treatment period there was 8-weeks no-treatment follow-up. The primary efficacy outcome was the change in number of satisfying sexual events (SSEs) after 4 weeks of therapy compared to a baseline period. Secondary efficacy outcomes included changes in the number of SSEs in the follow-up period; changes in the number of sexual events leading to orgasm, total Female Sexual Function Index (FSFI) score, FSFI “desire” domain, total Female Sexual Distress Scale-Revised (FSDS-R) score, FSDS Item 13 (“[How often... you were] Bothered by low sexual desire?”) score and assessment of Patient Global Impression of Improvement, PGI-I) after treatment, and after 4 and 8 weeks of follow-up. The incidence and nature of adverse events (AEs) was recorded. Results: The primary efficacy endpoint was met as Desirix (Orenetide) had a higher mean change in the number of SSEs after 4 weeks of treatment with the mean treatment difference of 1,83 (95,9% CI: 0,28-3,39; р=0,02) compared to placebo. Desirix (Orenetide) significantly increased SSEs compared to placebo at the 4-week - 2,38 (95% CI: 0,62-4,13;р<0,01) and 8week - 2,37(95% CI: 0,70-4,05;р<0,01) follow-up visits. Greater changes in total FSFI score and for “desire”, “arousal” and “orgasm” domains, as well as PGI-I score were reported at all time-points in the Desirix (Orenetide) treatment arm (p<0,05 vs placebo). Desirix (Orenetide) effectively reduced the signs of distress on the FSDS-R scale, and increased in the mean number of sexual events leading to orgasm at 4 weeks of treatment and at 8 weeks of follow-up (p<0.05 vs placebo). Most AEs were mild, caused no trial discontinuations and no serious treatment-related AEs were reported. Conclusion: Desirix (Orenetide) medicine is an efficacious and safe treatment for HSDD in premenopausal women.

BP101, hypoactive sexual desire disorder, lack or loss of sexual desire, Desirix, Orenetide, BP101, premenopausal women