Daré Bioscience to present Phase 1 sildenafil cream data showing dramatically lower systemic exposure
Daré Bioscience will present results from a Phase 1 study of its 3.6% topical sildenafil cream at the SMSNA Annual Fall Scientific Meeting in Orlando on October 9, 2026. The open‑label, single‑dose trial in healthy men compared the cream to a 50 mg oral dose and found plasma concentrations about 187‑fold lower and AUC about 33‑ to 34‑fold lower, with only mild adverse events and no serious events. The data support the company’s plan to develop the cream for female sexual arousal disorder and to seek FDA approval via the 505(b)(2) pathway.
Why it matters
The company says the lower systemic exposure could make the topical formulation a safer option for women with FSAD, potentially facilitating regulatory approval and market entry. Investors may view the data as a positive step toward a first‑in‑class treatment for a condition with no approved drugs.
Key facts
- 1The study will be presented at the SMSNA Annual Fall Scientific Meeting in Orlando, Florida, October 8‑11, 2026. globenewswire.com
- 2Annie Thurman, MD, FACOG, will present the data on Friday, October 9, 2026. globenewswire.com
- 3At a 71 mg topical dose, mean maximum plasma concentration was approximately 187‑fold lower than after a 50 mg oral dose. globenewswire.com
- 4Systemic exposure (AUC) was approximately 33‑ to 34‑fold lower for the topical dose versus oral. globenewswire.com
- 5All treatment‑emergent adverse events were mild; no serious adverse events, severe events, deaths, or discontinuations occurred. globenewswire.com
- 6Daré is pursuing FDA approval through the 505(b)(2) regulatory pathway while also offering a compounded version of the product. globenewswire.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.