Dare Bioscience (DARE) and its partner Strategic Science & Technologies said Monday they will submit a protocol and statistical analysis plan to the US Food and Drug Administration in Q1 for a phase 3 study of sildenafil cream, 3.6%, an investigational treatment for female sexual arousal disorder.
The companies said they plan to launch a phase 3 study of the topical drug in mid-2025.
The plan reflects FDA feedback for safety and efficacy, the company said.
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