Washington, Feb 23:
A US-based pharmaceuticals firm is all set to resubmit the world’s first female sex drug for the US Food and Drug Administration’s (FDA) approval.
The once-daily, non-hormonal pill called flibanserin developed by North Carolina-based Sprout Pharmaceuticals, once approved, will be the first prescription of its kind to treat women with Hypoactive Sexual Desire Disorder (HSDD) or low sex drive, the firm said in a press release.
“The FDA has devoted significant resources to understand HSDD and the need for medical treatment. I believe that the FDA’s efforts to bring together panels of patients and clinical experts will prove to be a significant step in bringing about a solution for women with HSDD to market,” said Cindy Whitehead, CEO of Sprout Pharmaceuticals.
“This year, I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution,” Whitehead continued.
While the FDA has approved medications for women that ease sex-related pain post-menopause, it has not yet approved a more general sex aid, like erectile dysfunction drugs available for men.
“The brain plays an important role in regulating a woman’s sexual desire and one of the root causes of persistent and recurrent low sexual desire, or HSDD, stems from an imbalance of neurotransmitters in the brain,” added Stephen Stahl, adjunct professor of psychiatry from the University of California in San Diego.
Flibanserin is believed to work by correcting this imbalance and providing the appropriate areas of the brain with a more suitable mix of brain chemicals to help restore sexual desire, he said.
The flibanserin safety profile has been well characterised in clinical trials over 11,000 women.
In all trials, flibanserin demonstrated a statistically significant difference compared to placebo on three key endpoints – an increase of sexual desire, a decrease in distress from the loss of sexual desire and an increase in the frequency of satisfying sex.
The most common side effects observed were dizziness, nausea and sleepiness, the release added.
The resubmission comes after Sprout received a complete response letter from FDA for flibanserin in 2013.
The firm appealed FDA’s decision, and at the request of the agency completed a phase one pharmacokinetic study and a phase one driving study.
Results from these studies were included in the re-submission package.
Having HSDD basically means a woman who is otherwise healthy has a lacking libido or a lack of sexual desire.
Studies show that about 10 to 20 percent of women face this problem globally and some say HSDD outnumbers men with sexual problems. IANS