Little Blue Pill

It’s the three-word phrase that revolutionized erectile dysfunction and generated worldwide awareness of a condition affecting some 30 percent of men. Nearly two decades after the FDA approved sildenafil for E.D., there’s another little pill making waves in the field of sexual dysfunction … only this time, it’s pink.

Flibanserin & HSDD

Manufactured by Sprout Pharmaceuticals to treat Hypoactive Sexual Desire Disorder, or HSDD, flibanserin failed to receive FDA approval in 2010 and again in 2014. In February, Sprout filed a new application for use in pre-menopausal women. Originally created by German pharmaceutical company Boehringer Ingelheim to treat depression, flibanserin switched gears when trial participants reported an increase in sexual desire.

In 2014 the drug was sold to Raleigh-based Sprout, which touts the non-hormonal treatment as the first-in-class, first-in-disease treatment for HSDD – a lacking libido in an otherwise healthy person. And while the “little pink pill” has failed to receive FDA approval, it’s succeeded in sparking a heated debate about women’s sexual dysfunction.

“Women’s sexual health is really misunderstood,” said Brooke Faught, MSN, WHNP-BC, IF, clinical director of the Women’s Institute for Sexual Health. WISH, a division of Urology Associates, treats women struggling with decreased desire, diminished arousal and orgasmic potential, and pain with intercourse, among other sexual and pelvic floor conditions.

“People still believe sexual dysfunction in women isn’t a medical entity because women with a low libido can still have intercourse, where men with erectile dysfunction can’t,” Faught said. “They don’t understand how debilitating it can be.”

Increasing Awareness

Faught, who trained at a similar clinic in Philadelphia, was brought on to enhance women’s health services at WISH 10 years ago. She now treats patients from across the U.S. and internationally from her Nashville practice. And while the concept of women’s sexual dysfunction was once a blush-inducing novelty in the American South, Faught said the Nashville community has embraced the condition as a real problem affecting a reported 43 percent of women.

That’s thanks, in part, to awareness campaigns like “Even the Score,” which work to promote women’s sexual health equity. “If you’re a man with sexuality issues, you can take a ‘magic pill,’” Faught said. “But for those women who’ve become accustomed to not having sex, many experience changes in vaginal tissue and then are suddenly expected to jump on the bandwagon again. Many are suffering in silence.”

Like men, women go through various stages in their sexual lives, with no age limit as to when they’ll quit having sex. Faught treats patients in their 90s still eager to make the most of their love lives. And clinics like WISH are often the sole place women feel comfortable discussing such intimate concerns.

“I have patients in my office in tears, all day, every day,” said Faught. “Women in general are just super complicated when it comes to addressing and dealing with sexual dysfunction, as so many things play a role when it comes to arousal and libido. The pathway is complicated.” That’s because – unlike men – the woman’s primary sexual organ is the brain.

Diagnosis & Treatment

Hormones clearly play a large role in sexual health, but while testosterone patches and gels have helped women in Europe, they’ve yet to be approved in the United States. Faught said many sexual health providers turn to compounded test products but admits that keeping testosterone levels in normal ranges long-term can be tricky. Menopause, breastfeeding, diabetes or thyroid problems, prescription medications and long-term use of birth control pills also can cause dysfunction.

“Treatment is really individualized, and there’s no ‘one size fits all’ protocol,” explained Faught, who said a solution is rarely as simple as low testosterone. ”I most often see biological causes, although there are still many women in crummy relationships or with a history of sexual abuse.”

Recommended treatment can range from general counseling or sex therapy to a change in depression, cholesterol or blood pressure medications, which can decrease sexual sensation. Patients often need encouragement to simply lay a healthier foundation: drink more water, eat healthier and exercise. “There’s no magic pill, even if something were to be approved,” Faught said.

The Future of Flibanserin

Critics of flibanserin say HSDD is a made-up condition to benefit big pharma … essentially, the emotional connection women typically need to enjoy sex can’t be replaced by a pill. Similarly, some worry men might pressure or force their partners to take such a pill to increase their own sexual fulfillment. Regardless of the reasons, the FDA still needs more convincing.

“The FDA says we need more data, more proof that it’s needed,” Faught said. “They want to see an overwhelming efficacy with the medication.”

In an emailed statement to Nashville Medical News from the FDA, the agency said they “cannot discuss any drug application that is still under regulatory consideration. Currently, the FDA continues to work with the company to determine whether the drug’s benefits could outweigh its risks.” Side effects of flibanserin, which works on neurotransmitters, include nausea, anxiety, insomnia and dizziness.

The missive went on to say, “The FDA’s regulatory decision-making on any drug product is a science-based process that carefully weighs each drug in terms of its risks and benefits. The agency evaluates drugs based on science and strongly rejects claims of gender bias. The FDA strives to protect and advance all important areas of women’s health, including disorders of female sexual function.”

In June, Faught will head to D.C. to help advocate for women’s sexual health. While the topic might be slow moving, it is moving thanks to voices like Faught’s.

In 2012, the FDA identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention. The agency subsequently held a two-day meeting last October to advance their understanding of female sexual dysfunction.

“We are committed to working with companies to develop safe and effective treatments for female sexual dysfunction, as we do for all areas of unmet medical needs,” said the FDA in a statement. 

Faught is crossing her fingers for a 2015 approval on flibanserin. “The concern is if it doesn’t go through, pharmaceutical companies will give up on the issue altogether, as so much money has already gone into marketing and awareness for this issue with no financial return,” she said.

RELATED LINKS:

WISH Clinic: www.wishnashville.com

Even the Score: http://eventhescore.org

Sprout Pharma: http://sproutpharma.com