BP-101) for hypoactive sexual desire disorder (HSDD) in premenopausal women met the pre-specified pr29 Jul 2020 16:57
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Ovoca Bio plc's Libicore (BP-101) Meets Primary/Secondary Endpoints in Phase 3 Trial for Hypoactive Sexual Desire Disorder Ahead of Time
-- Phase 3 study of Libicore (BP-101) for hypoactive sexual desire disorder (HSDD) in premenopausal women met the pre-specified primary efficacy endpoint of improvement in number of sexually satisfying events:
o In the trial, Libicore (BP-101) showed a statistically significant increase in the number of satisfying sexual events (SSEs) versus placebo (difference in the mean increase in SSEs of 1.83 (95% CI of 0.28-3.39) at the tested daily dose of 2.52mg (p = 0.016)
-- Statistically significant results versus placebo also were seen in the key registration endpoints of:
o Female Sexual Function Index: Desire Domain (FSFI-D) showed a statistically significant mean increase of 1.14 (0.94-1.34) for Libicore (BP-101) vs. 0.58 (0.38 - 0.78) on placebo, p=0.0001; and,
o The Female Sexual Distress Scale - revised (FSDS-R) Item 13 showed a statistically significant mean reduction of -1.2 (-1.4 to -1.0) vs. -0.7 (-0.9 to -0.5), p=0.0019.
-- The pivotal clinical trial, evaluating the efficacy and safety of Libicore (BP-101) versus placebo was stopped early based on the achievement of pre-specified efficacy criteria.
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