Daré Bioscience Reports Phase 1 Sildenafil Cream Data Showing Lower Systemic Exposure

(RTTNews) - Daré Bioscience, Inc. (DARE) announced the peer-reviewed publication of Phase 1 clinical data evaluating its proprietary Sildenafil Cream, 3.6% in healthy adult men, with results showing substantially lower systemic exposure compared with a 50 mg oral dose of sildenafil.

The study, published in Sexual Medicine, evaluated the safety and systemic pharmacokinetics of topical Sildenafil Cream administered at 36 mg and 71 mg doses, with and without condom use, compared with oral sildenafil.

The 62-participant study found that topical treatment resulted in mean maximum plasma sildenafil concentrations ranging from 969 to 1,274 pg/mL across the four topical dosing groups, compared with 238,000 pg/mL for the oral sildenafil group.

At the 71 mg topical dose, mean maximum plasma concentration of sildenafil was approximately 187-fold lower than following the 50 mg oral dose.

Systemic exposure measured by AUClast and AUCinf was approximately 33-fold and 34-fold lower, respectively.

Phase 1 Study Results

The randomized, open-label study enrolled 62 healthy men who received a single dose of topical Sildenafil Cream or a 50 mg oral sildenafil tablet.

The study evaluated safety and pharmacokinetics of sildenafil and its active metabolite, N-desmethyl sildenafil.

All 14 treatment-emergent adverse events reported during the study were mild. Seven events occurred in five participants who received oral sildenafil.

No serious or severe adverse events, deaths or treatment discontinuations due to adverse events were reported.

Relative bioavailability of sildenafil following topical administration ranged from 2.55% to 3.20%, indicating substantially lower systemic exposure than the oral formulation.

The study was designed to assess safety and pharmacokinetics in healthy men without erectile dysfunction and did not evaluate efficacy or erectile response.

Sildenafil Cream Development

Daré's proprietary Sildenafil Cream, 3.6% is being developed as a localized delivery approach for sexual arousal concerns in women.

The 71 mg sildenafil dose administered in 2 grams of cream was subsequently evaluated in a Phase 2b study in premenopausal women with female sexual arousal disorder.

The company said the Phase 1 findings provide additional clinical evidence characterizing the pharmacokinetic profile of its topical formulation and support continued development in women's sexual health.

Near-term Catalysts

The key catalyst for Daré is continued development of Sildenafil Cream, 3.6% for female sexual arousal disorder, supported by the published Phase 1 safety and pharmacokinetic findings.

The peer-reviewed publication adds to the clinical evidence for the company's localized sildenafil delivery approach, while the company remains focused on developing treatments for women's health.

DARE has traded between $0.69 and $3.78 over the past year. Currently, the stock is trading at $0.71, up 0.69%.