Phase 3 Reconnect Studies
The Phase 3 Reconnect Studies were in premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD), either with or without arousal difficulties. HSDD is the single largest specific diagnosis in female sexual dysfunction (FSD). The 24 week double blind placebo controlled studies have completed. Both Phase 3 Reconnect Studies of Vyleesi™ for HSDD in premenopausal women met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.
Details of the Phase 3 Reconnect Studies
The Phase 3 Reconnect Studies consisted of two double blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg Vyleesi delivered via an autoinjector pen to placebo. Each trial randomized over 600 patients into an active treatment or placebo arm with a 24 week evaluation period.
There are two co-primary endpoints in the Reconnect Studies, which measure change in the Female Sexual Function Index, or FSFI, desire domain (FSFI-D) and improvement in the degree of bothersomeness of HSDD as assessed by question 13 of the revised Female Sexual Distress Scale, or FSDS, questionnaire (FSDS-DAO Item 13).
The FSFI-D showed a statistically significant increase for Vyleesi compared to placebo in both trials:
- Study 301: Mean change of 0.54 vs. 0.24, median change of 0.60 vs. 0.00, p=0.0002; and,
- Study 302: Mean change of 0.63 vs. 0.21, median change of 0.60 vs. 0.00, p<0.0001.
The FSDS-DAO Item 13 showed a statistically significant reduction in distress related to low sexual desire for Vyleesi compared to placebo in both trials:
- Study 301: Mean change of -0.73 vs. -0.36, median change of -1.0 vs. 0.0, p<0.0001; and,
- Study 302: Mean change of -0.71 vs. -0.42, median change of -1.0 vs. 0.0, p=0.0053.
Women in the trials had the option, after completion of the trial, to continue in an open-label safety extension study for a period of 12 months. All patients in the open-label safety extension study received Vyleesi, and the safety extension study was completed in the second quarter of calendar year 2017. This data will be used to support the long term safety of Vyleesi used as an “on-demand” treatment for HSDD.
We are continuing to analyze data from the Reconnect Studies, and expect to present additional results at future sexual medicine and women’s health conferences and in peer reviewed journal publications.
With our licensee, AMAG Pharmaceuticals, Inc., a New Drug Application was filed in the first quarter of 2018 with the Food and Drug Administration (FDA) to support approval of Vyleesi as an “on-demand” treatment for premenopausal women with HSDD. The FDA has set a goal date for completion of review of the New Drug Application of March 23, 2019.