08:50 AM EST, 12/16/2024 (MT Newswires) -- 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.