Daré Bioscience Announces Positive End-of-Phase 2 Meeting with FDA on Development of Sildenafil Cream, 3.6% in Female Sexual Arousal Disorder and Provides Company Focus Areas for 2024

There are no FDA-approved treatments for female sexual arousal disorder

SAN DIEGO, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the successful completion of an end-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA), supporting advancement of Sildenafil Cream, 3.6% (Sildenafil Cream) 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.

Progressing Towards Sildenafil Cream Phase 3 Pivotal Study

The Company and the FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) 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 (other than sildenafil) for the vaginal route of administration.

Daré has also requested clarification on the safety database (size and duration of exposure) required for an NDA submission.

“We are pleased to have had a positive EoP2 meeting with the FDA as we work towards aligning on the Phase 3 program for Sildenafil Cream, which has the potential to address the significant unmet need associated with arousal disorder, which impacts approximately 10 million women in the U.S.,” said Dr. Andrew Goldstein, M.D., Medical Advisor for Daré Bioscience. “Given that there are currently no FDA-approved products for FSAD, we appreciate the FDA’s guidance and support and look forward to finalizing the Phase 3 protocol as we work to advance this product candidate into its first Phase 3 clinical study.”