Daré announces Phase 3 plans for Sildenafil Cream for FSAD; protocol submission in Q1 2025

Dare Bioscience, Inc.

Will submit Phase 3 protocol and statistical plan to FDA in Q1 2025; target mid-2025 to start the study.
A second confirmatory Phase 3 study will be required for NDA submission.
Phase 3 co-primary endpoints are arousal sensations and associated distress, same as Phase 2b RESPOND study.
Sildenafil Cream has potential to be first FDA-approved pharmacological treatment for FSAD (no current approved options).
Market research estimates ~10M U.S. women distressed by FSAD symptoms actively seeking solutions.

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