THE PHARMACEUTICAL COMPANY attempting to bring the first female ‘Viagra’ product have been told by the US Food and Drug Administration (FDA) that more studies are needed as some women taking the pill experience sleepiness.

Sprout Pharmaceuticals have been instructed to resubmit their drug application for “Flibanserin” – the first potential medical treatment to treat a women’s lagging libido – after they complete two additional drug interaction studies which will include 25-50 healthy volunteers.

The new studies aim to identify if there is any possible driving impairment, as 9.8 per cent of women experience sleepiness, while on 100 milogrammes of the drug.

The drug hopes to treat pre-menopausal women who have Hypoactive Sexual Desire Disorder (HSDD) with a once-daily treatment.

Sexual fantasies

HSDD is described as a female sexual dysfunction whereby women have a “persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity” that causes distress for many.

Flibanserin is believed to work on key neurotransmitters in the brain that affect sexual desire. More specifically, it is thought that the drug corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine – both responsible for sexual excitement and decreasing serotonin which is responsible for sexual inhibition.

Satisfying

In clinical studies, Flibanserin was evaluated for its ability to “increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss,” said the Sprout Pharmaceuticals.

“We are encouraged by the FDA’s response and view it as a significant step toward the approval of Flibanserin,” said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals.

“With data in over 11,000 patients to date, we are confident that further supporting the predictable risk/benefit profile of Flibanserin will result in women having the first ever treatment for the most common form of female sexual dysfunction. We are committed to working closely with the Agency to finally provide pre-menopausal women affected by HSDD with a medical treatment option,” she said.

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