Tuesday, August 18, 2015

“Female Viagra” Finally Approved by FDA

FDA officials finally approved the first-ever prescription drug intended to treat women suffering from a lack of sexual desire. That is correct – Women Viagra exists, and will be appearing on the market late October.

Sprout Pharmaceuticals Inc. will sell the drug, flibanserin, under the name Addyi for women who have not yet gone through menopause and suffer from low libido, according to a statement from the regulatory agency.

However, the FDA put restrictions on who can prescribe the drug to address serious side effects such as fainting if combined with certain other drugs or alcohol. Additionally, doctors will not be able to prescribe it unless they complete an online certification test.

How does it work?

Addyi acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs. In fact, it was originally studied as a treatment for depression before being repurposed into a libido drug. It is not entirely clear why the drug increases sexual desire but researchers point to its ability to increase dopamine — a brain chemical associated with appetite — while lowering serotonin — another chemical linked with feelings of satiation.

Who will take this drug?

The FDA approved Addyi for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.

Surveys estimate that between 5.5 million to 8.6 million U.S. women have the condition, or roughly 8 to 14 percent of women ages 20 to 49. Because so many other factors affect sexual appetite, there are a number of alternate causes, doctors must rule out before diagnosing the condition, including relationship problems, medical conditions and mood issues caused by other medications like sleeping aids and painkillers.

The diagnosis is not universally accepted and many psychologists argue that low sex drive should not be considered a medical condition.

The rumors are this decision was controversial, why?

The drug followed a long, contentious path to approval, including two previous rejections by the FDA. For years, two opposing sides have argued over the fate of the drug.

On one hand, drugmakers and some medical experts argue that women need FDA-approved medications to treat sexual disorders, which they consider serious medical problems. On the other side, consumer-safety advocates have said the drug's side effects are too risky, and there are those who question whether low libido is a medical condition.

On top of this debate, Sprout Pharmaceuticals enlisted outside politicians and women's groups to lobby the FDA to approve the drug.

Does the drug work?

Experts usually describe Addyi's effect as "modest." In company studies, women taking flibanserin reported a slight increase in sexually satisfying events each month. Their answers to separate questionnaires indicated they experienced a slight increase in desire and a slight decrease in stress.

While FDA scientists describe these effects as "small," they were significant enough to meet FDA effectiveness standards.

In clinical trials, women who took Addyi recorded a median increase of 0.5 to one more satisfying sexual events each month than those who got a placebo. Women began the trials experiencing two to three satisfying sexual events a month. Some women experienced as many as six to eight more satisfying sexual events each month.

Addyi’s label will advise women to stop taking the pill if they do not respond after eight weeks.

What are the side effects?

About 10 percent of patients in Sprout's studies experienced the most common problems: dizziness, fatigue and nausea. The drug will also bear a boxed warning that women should not drink alcohol or take certain types of other medications, including antifungal drugs, because of an interaction that can cause low blood pressure and fainting.

How much will it cost?

Sprout says women who have health insurance will pay between $30 and $75 for a month's supply of Addyi, depending on their coverage terms.

History of Research

The search for a pill to treat women's sexual difficulties has been something of a holy grail for the pharmaceutical industry. It was pursued, and later abandoned, by Pfizer, Bayer and Procter & Gamble, among others. All drugs that act on blood flow, hormones and other biological functions, were proved being ineffective.

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