Daré's Sildenafil Cream shows lower plasma levels in Phase 1

• Sildenafil Cream, 71 mg produced a mean maximum plasma concentration roughly 187-fold lower than the 50 mg oral dose.
• The oral sildenafil group reached a mean maximum plasma concentration of 238,000 pg/mL.
• Topical dosing groups showed mean maximum plasma concentrations ranging from 969 to 1,274 pg/mL.
• The Phase 1 study enrolled 62 participants in an open-label, single-dose, randomized, parallel-group design.
• All 14 treatment-emergent adverse events were mild, and no serious adverse events were reported.

Phase 1 Results

Sildenafil Cream, 71 mg, produced an AUCinf approximately 34-fold lower than the oral dose.

Daré's Sildenafil Cream shows lower plasma levels in Phase 1

AUClast for the topical dose was approximately 33-fold lower than oral sildenafil.

Relative bioavailability across topical dosing groups ranged from 2.55% to 3.20%.

Study Design

The study was designed as a safety and pharmacokinetic evaluation in healthy men without erectile dysfunction and did not assess efficacy or erectile response.

Researchers evaluated sildenafil and its active metabolite, N-desmethyl sildenafil.

Adverse Events

Seven of the 14 treatment-emergent adverse events occurred in five participants who received oral sildenafil.

All treatments were well tolerated, with all 14 treatment-emergent adverse events classed as mild and none serious.

Next Steps

The 71 mg dose in 2 grams of cream was subsequently tested in a Phase 2b study of Sildenafil Cream, 3.6%, in premenopausal women for treatment of female sexual arousal disorder.

Sildenafil Cream, 3.6%, has previously been clinically evaluated in women with female sexual arousal disorder.

Results from the Phase 1 study were published in Sexual Medicine.

Company

David Friend, PhD, serves as Chief Scientific Officer of Daré Bioscience.

Sabrina Martucci Johnson serves as President and Chief Executive Officer of Daré Bioscience.