RALEIGH: Drug maker seeks FDA approval for 'female Viagra' - WFSB 3 Connecticut

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Pink pill may be miracle drug for women with low sex drives

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Located at North Hills in Raleigh, Sprout Pharmaceuticals is the developer of flibanserin, a non-hormonal drug that treats sexual dysfunction in pre-menopausal women. Located at North Hills in Raleigh, Sprout Pharmaceuticals is the developer of flibanserin, a non-hormonal drug that treats sexual dysfunction in pre-menopausal women.
Flibanserin is a non-hormonal drug that treats sexual dysfunction in pre-menopausal women. Flibanserin is a non-hormonal drug that treats sexual dysfunction in pre-menopausal women.
RALEIGH, N.C. -

A Triangle company is leading the charge to provide groundbreaking treatment for millions of women in the United States who are plagued by a low sex drive.

One in every 10 women suffer from what is known as hypoactive sexual desire disorder, a sexual dysfunction that is characterized by a lack of sexual fantasies and desire for sexual activity due to an inability to turn off life's distractions.

According to Even the Score, a women's sexual health advocacy group, there are 26 FDA-approved treatments marketed for male sexual dysfunction. Yet, while 10 percent of women have HSDD, there's hasn't been a medical treatment option for them.

"It's surprising that more women than men suffer from sexual dysfunction, and yet there isn't a single medical treatment option," said Sprout Pharmaceuticals CEO Cindy Whitehead.

That's where Sprout's little pink pill comes in.

Located at North Hills in Raleigh, Sprout is the developer of flibanserin, a non-hormonal drug that treats sexual dysfunction in pre-menopausal women.

"Sex is complex," Whitehead explained. "We all bring our background in the bedroom; we bring our relationship dynamic in the bedroom. But we all bring biology into the bedroom."

Flibanserin is known as the "female Viagra," but there are some big differences. While Viagra is used on an as-needed basis, flibanserin is taken daily.

"It works on key chemicals in the brain to basically increase desire and decrease distress," Whitehead said. "So it has a positive effect on the positives, and a negative effect on the negatives."

Research into flibanserin has lasted 12 years, and more than 11,000 women have been involved in clinical trials.

Barbara Gattuso, who suffers from HSDD, is among those who have participated in clinical trials. While she enjoyed life in San Diego, she said she knew something was missing.

"I have a wonderful husband, marriage, but no desire for sex," Gattuso said. "You feel awful, worthless, like you're contributing to [the] possible breakup of marriage or [your] husband going elsewhere."

Just two weeks after she started taking flibanserin, Gattuso said she noticed significant changes.

"I had desire," she said. "I would wake up in the middle of the night and have desire -- I felt like I was 20 years old again."

She laughed, "What''s the cliché? Happy wife, happy husband."

While flibanserin has undergone 15 times as many clinical trials as the typical drug, the miracle pill for millions of women may still be a ways from going into full production.

Sprout submitted its application to the Food and Drug Administration in March 2013, but it was denied approval in September because the agency said it wanted more tests. The FDA's main concern is the side effects, which include dizziness, nausea, fatigue and sleepiness.

Part of the new trials will be to see how the drug interacts with other drugs and how it impacts driving abilities. Sprout said 9.8 percent of women experience sleepiness while on flibanserin 100mg.

Sprout hopes to re-submit by the end of the year with approval potentially by the end of 2015. Until then, the company said it will remain focused on running more trials and raising more funding to gain that approval.

"If there's something available, why are we being denied the choice to take the medication?" asked Gattuso. "Why are we being denied the opportunity to have pleasure in our life?"

If the drug receives approval, Sprout expects to hire for about 300 jobs in the Triangle alone.

Amid controversy over claims by drug companies and groups like Even the Score that the FDA has failed to approve drugs to treat female sexual dysfunction, the agency plans to host a public meeting and scientific workshop on the topic on Oct. 27 and 28 at its White Oak Campus in Silver Springs, Md.

Click Here for information on how to register for the meeting. Registration closes Oct. 20.

Copyright 2014 WNCN. All rights reserved.

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