Local News

Raleigh-based company seeking FDA approval for 'female Viagra'

Posted September 9, 2014 8:22 a.m. EDT
Updated September 9, 2014 8:55 a.m. EDT

— More than 20 drugs are available to treat male sexual dysfunction, but never before has there been a pill for women.

Sprout, a Raleigh-based pharmaceutical company, is hoping its little pink pill will be the first.

Forty-three percent of women suffer from some kind sexual dysfunction, with many suffering low desire. The biggest culprit is hypo-active sexual desire disorder.

Sexual stimulation deactivates parts of the brain involved with information analysis, or the day-to-day tasks, to allow women to focus on the sexual experience. Women with HSSD can’t shut down the daily distractions.

Enter Flibanserin, the little pink pill that has shown promising results in tests.

“It works on key chemicals in the brain to increase desire and decrease the stress,” Cindy Whitehead, chief operating officer of Sprout, said. “(Women) want to want. They had a desire before, and they lost that, and it’s really causing profound stress either for them personally or in their relationship dynamic.”

Sprout purchased the rights to Flibanserin three years ago and has been working since then to get it approved by the Food and Drug Administration.

On average, women in clinical trials doubled the number of satisfying sexual events and reported a 50 percent increase in sexual desire.

The FDA denied approval of the drug last year, saying it wanted to see additional work. Several prominent women’s groups and Congressmen, including Rep. David Price, of North Carolina’s 4th District, responded by writing letters to the FDA in support of the drug.

Price says the FDA needs to approve Flibanserin.

“I don’t know what reason there could possibly be for treating male sexual dysfunction and not female sexual dysfunction, assuming that we have a medication here that is safe,” Price said.

Sprout is appealing the FDA’s ruling, and the company is finishing two studies focused on drug interactions and side effects. The most common side effects are fatigue, nausea and dizziness.

Sprout will resubmit for approval in December. If the FDA gives the company the go-ahead, the drug could be ready for the public by the middle of 2015. Capitol Broadcasting, parent company of WRAL, is an investor in Sprout Pharmaceuticals.

“Hopefully, if we’re able to do that, we break down a barrier and a variety of treatment options come forth, because women deserve those as well,” Whitehead said.