Alprostadil Shows Efficacy in Female Sexual Arousal Disorder

Emma Hitt, PhD

May 25, 2012

May 25, 2012 (Atlanta, Georgia) — A new formulation of alprostadil cream 0.4% (Femprox, Apricus Biosciences Inc), administered topically, significantly improved symptoms of female sexual arousal disorder (FSAD) in pre- and postmenopausal women, according to the findings of a randomized, placebo-controlled, phase 3 study.

Irwin Goldstein, MD, director, Sexual Medicine, Alvarado Hospital, San Diego, California, and colleagues presented their findings here at a moderated poster session at the American Urological Association (AUA) 2012 Annual Scientific Meeting.

"Female sexual arousal disorder is the second most common sexual health concern, affecting 26% of adult women," Dr. Goldstein told Medscape Medical News, "and about 1 in 5 are distressed by the condition, although research in women's sexual health is limited and more is needed."

No product is currently approved to treat FSAD, a persistent or recurring inability to attain or maintain adequate sexual excitement that causes personal distress, note the manufacturers of the formulation on their Web site.

Femprox has been formulated to contain the skin-penetration enhancer dodecyl 2-(N,N-dimethylamino)-propionate, which, according to the researchers, loosens tight junctions of skin cells, thereby enhancing delivery of alprostadil. Alprostadil leads to vasodilation, smooth muscle relaxation, and increased blood flow when applied to female sexual organs.

A total of 387 women were given 10 identical doses of 500 mcg, 700 mcg, or 900 mcg of alprostadil cream or placebo to be used during an 8-week treatment period that was preceded by a 4-week nontreatment baseline period.

Response was measured through the number of satisfactory sexual events (SSEs). Participants were also monitored using the Female Sexual Function Index (FSFI), the Global Assessment Questionnaire (GAQ), and the Female Sexual Distress Scale (FSDS).

SSEs improved with the alprostadil cream at all doses, with a significant improvement (P = .0002) observed with the highest (900 mcg) dose (46.3%, 43.5%, and 53.9% for 500 mcg, 700 mcg, and 900 mcg, respectively, compared with 33.1% in the placebo group). The 900-mcg dose also resulted in significant improvements in FSFI, GAQ, and FSDS scores compared with women receiving placebo.

The best efficacy for the cream was observed in patients aged 45 years or younger, Dr. Goldstein and colleagues noted in the poster. In addition, more patients aged 46 years or older reported mild to moderate local adverse events with the 900-mcg dose.

According to Dr. Goldstein, there are no Food and Drug Administration–approved agents for women with sexual dysfunction, although several female arousal gels are available over the counter. "The current placebo-controlled trial showed that the active drug versus placebo increased in a safe and effective manner female sexual function using validated measures of female sexual function," he said.

"Women who have female sexual arousal disorder will now have a safe and effective treatment option to improve their sexual function," Dr. Goldstein added. "This medication may benefit a subset of women who are bothered by decreased sexual arousal and whereby enhancing genital arousal will result in improved sexual function."

James A. Simon, MD, a clinical professor at George Washington University in Washington, DC, and president and medical director of James A. Simon, MD, PC, Women's Health & Research Consultants, told Medscape Medical News that "whether a woman would be willing to apply the cream to the genital area (clitoris and G-spot) rather than take a pill [off-label: Viagra, Levitra, or Cialis] remains a significant impediment to use of this preparation."

He added that this study was conducted entirely or primarily in China, and "it is not clear whether women of other cultures (ie, those in North America) would respond similarly or that the interpretation of the rating instruments used (FSFI, GAQ, and FSDS) would be the same."

According to Dr. Simon, FSAD is an important gynecologic problem across the lifespan that increases in older menopausal women. "It may be genital (ie, a vascular condition) or subjective (the sense that there is no arousal even if objectively there is). In the former case, Femprox would be an important addition to the available clinical armamentarium."  

The study was funded by Apricus. Dr. Simon has disclosed no relevant financial relationships.

American Urological Association (AUA) 2012 Annual Scientific Meeting. Abstract #1498. Presented May 22, 2012.

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