Female sexual arousal disorder (FSAD) is the inability to reach or maintain a sufficient physical response to sexual stimulation. An estimated 16% of women ages 21 to 60, or approximately 10 million women in the U.S., are distressed from experiencing symptoms of low or no sexual arousal and are seeking a solution to improve their condition. To put the market opportunity for an FDA-approved FSAD treatment in context, the prevalence of complete erectile dysfunction (ED) in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.
Still, there are currently no FDA-approved therapies for FSAD. Orally administered sildenafil received FDA approval in 1998 for the treatment of erectile dysfunction in men and is marketed under the brand name Viagra®. Given the underlying pathophysiologic similarities of ED and FSAD, using sildenafil to direct blood to the genitals before sexual activity could provide a potential improvement in genital arousal response and overall sexual experience for women as it does in men.
Our localized, proprietary formulation of sildenafil cream, 3.6% (topical cream, sildenafil), has been designed specifically for women. The targeted application of this cream to the genital tissue is designed to increase local blood flow without the associated systemic exposure and side effects, leading to an improvement in overall sexual experience and response.
In a previous study of sildenafil cream, 3.6% in women with FSAD (n=31), the product candidate increased measurable blood flow to the genital tissue when compared to placebo. The planned Phase 2 trial will evaluate the product candidate’s efficacy compared to placebo to relieve symptoms of FSAD in women with the condition when used by the women in their home setting.
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