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FDA approves first female sexual disorder drug

The ‘little pink pill’ has had a difficult path to market and comes with safety warnings


Sprout Pharmaceuticals' Addyi has become the first drug to be approved in the US for reduced sexual desire in women.

The 'little pink pill' - which contains the non-hormonal drug flibanserin - finally got the go-ahead from the FDA at the third attempt, ending a marathon development effort marked by rejections by the agency in 2010 and 2014.

The FDA has approved the drug for generalised hypoactive sexual desire disorder (HSDD) in premenopausal women and said this is the first time that a drug has been approved for sexual disorders in either men or women.

It is designed to work on serotonin receptors in the prefrontal cortex of the brain to restore 'normal' sexuality to women who feel their libido has become reduced. In trials, women taking the drug reported an increase in satisfying sexual events, improved sexual desire and reduced levels of distress related to low sexual desire.

As predicted after Addyi cleared an FDA advisory committee in June by a vote of 18 to six, the labelling for the drug contains a boxed warning about the risks of severe low blood pressure and fainting in patients who drink alcohol or have reduced liver function.

The warning also extends to women who use other drugs that are moderate or strong inhibitors of the drug metabolising enzyme - a group which includes certain antibiotics and antifungals, HIV drugs and blood pressure drugs, amongst others.

In these cases, metabolism of Addyi can be reduced and blood levels of the drug will increase markedly.

This profile means that Sprout has had to develop a Risk Evaluation and Mitigation Strategy (REMS) to make sure the new drug is used safely, including training and certification of prescribers and dispensers.

"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies, said Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research (CDER).

"Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment," she added.

The drug was originally developed by Germany's Boehringer Ingelheim, but was after it became clear the regulatory route to approval was uncertain. Sprout acquired rights to the programme in 2011.

Sprout is staying tight-lipped on its sales projections for the product - and as yet there is no word on pricing - but there does seem to be a core of women anticipating Addyi's US launch, which is set for October.

More than 40,000 women added their names to a petition urging the FDA to approve the drug, according to a recent report in the New York Times.

Article by
Phil Taylor

19th August 2015

From: Regulatory



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