Dare Bioscience announces completion of end-of-Phase 2 meeting with U.S. FDA

Dare Bioscience announced the successful completion of an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, FDA, supporting advancement of Sildenafil Cream, 3.6% for the treatment of female sexual arousal disorder (FSAD) to a Phase 3 clinical study. The Company also provided an update on focus areas for 2024. The Company and the FDA aligned on key elements of the Phase 3 program to support a New Drug Application filing, including confirming that: FSAD is acceptable as an indication. The trials can be conducted in a premenopausal FSAD-only population. 12-weeks of blinded treatment to assess efficacy may be acceptable, provided that the trials are adequately powered for efficacy assessment. This is a shorter period of blinded treatment than the 24 weeks recommended in 2016 draft FDA guidance for developing drugs for the treatment of low sexual interest, desire and/or arousal in women. Additionally, the FDA indicated that feedback is forthcoming on the following: Primary and secondary patient reported outcome endpoints which will be used in Phase 3 pivotal trials and support potential product registration and labeling. Additional information on data that may be needed in an NDA submission to appropriately qualify any ingredient for the vaginal route of administration. Dare has also requested clarification on the safety database (size and duration of exposure) required for an NDA submission.