Sildenafil Cream for Women Brings Safety Data to SMSNA

Daré Bioscience took the stage in Orlando this month with new Phase One results for its experimental Sildenafil Cream for Women, presenting safety data at the annual fall meeting of the Sexual Medicine Society of North America that the company says strengthens the case for the first drug developed for female sexual arousal disorder.

The presentation, delivered Friday by the company's medical director Dr. Annie Thurman during the Innovations in Sexual Medicine Abstracts session, centered on an open label, single dose, randomized study comparing the topical formulation against the standard oral pill. The meeting, held in Orlando from October eighth through the eleventh, is the main annual gathering for physicians who specialize in sexual medicine. The findings were recently published in Sexual Medicine, the official journal of the International Society for Sexual Medicine, according to the company, and the full announcement is available from GlobeNewswire.

At the trial's seventy-one milligram topical dose of the Sildenafil Cream for Women, peak sildenafil concentration in the blood came in roughly one hundred eighty-seven times lower than after a fifty milligram oral tablet, while total drug exposure over time ran about thirty-three to thirty-four times lower, the company reported. Every treatment-emergent side effect in the study was mild. There were no serious adverse events, no severe events, no deaths, and no participants stopping treatment because of side effects.

The study enrolled healthy men and measured only safety and how much of the drug entered the bloodstream; it did not test whether the cream improves sexual function. Daré says the numbers matter because that same dose is the one it tested in its Phase Two b trial of Sildenafil Cream for Women in premenopausal women with female sexual arousal disorder, a condition for which no drug has yet won approval from the Food and Drug Administration.

What the women's trial showed

In the two hundred-woman Phase Two b trial, the Sildenafil Cream for Women significantly increased reported arousal sensation and reduced sexual distress in a central subgroup of participants, with efficacy results published in Obstetrics and Gynecology and safety results in the Journal of Sexual Medicine. The cream was well tolerated, with no difference in side effects compared with the placebo cream, according to the company.

The exposure gap helps explain why. Oral sildenafil can lower blood pressure and cause headache, flushing, nausea, and dizziness; in the women's trial those effects did not appear, most likely because so little of the drug reached the bloodstream, lead author Dr. Thurman has said, as reported by Urology Times. Daré describes female sexual arousal disorder as the clinical counterpart of erectile dysfunction in men: a persistent inability to maintain sufficient genital arousal during sex, often linked to reduced blood flow, that frequently causes real distress or strain in relationships. Company market research estimates roughly ten million women in the United States are actively looking for help with its symptoms.

Why the pipeline matters

Women's sexual health has received a fraction of the research attention given to men's. Viagra reached the market in the late nineties, and nearly three decades later women with an analogous condition still have no approved drug option of their own. Patients are routinely told their choices are limited to therapy, lubricants, or waiting for the problem to pass. That is the gap the Sildenafil Cream for Women is being developed to fill.

The new peer-reviewed numbers give Daré something the program lacked before: published evidence that a targeted cream can deliver sildenafil where it is needed without routing most of it through the body. The cream remains investigational. The company has said it plans to pursue Phase Three trials following feedback from regulators, which could make the Sildenafil Cream for Women the first approved treatment for the condition. Its earlier securities filing said two confirmatory studies would be needed to support an eventual new drug application.

For the millions of women living with the condition, each public milestone for the Sildenafil Cream for Women narrows a gap that has sat open since the late nineties. Whether regulators decide the benefit is strong and consistent enough will be settled in the trials ahead.