UPDATED: FDA to Decide on Approval for Women's Libido Drug, Flibanserin

UPDATED: FDA to Decide on Approval for Women's Libido Drug, Flibanserin
August 19, 2015

The "little blue pill" has been on the market for years, and this week the U.S. Food and Drug Administration (FDA) will decide if it will be joined by a pink counterpart.

Flibanserin, manufactured by Sprout Pharmaceuticals of Raleigh, NC, is a drug designed to treat low libido in women, often incorrectly referred to as the "female Viagra." The drug is seeking FDA approval for a third, after being denied twice since 2010, CNBC reports.

The result could be different this time after gaining the support of Even the Score, a group that advocates for women's sexual health equity. Dozens of women filled FDA hearing rooms over the past year to testify about the great benefit a libido aid could have had for their marriage.

"It's important to put the patient voice at the center of the discussion," Sprout CEO Cindy Whitehead told CNBC in an interview.

In June, an FDA advisory panel voted to recommend approval of flibanserin, provided that Sprout take certain steps to limit the pill's risks.

The decision has its share of doubters, however. Critics say that Sprout hasn't made any changes to the science behind flibanserin since the last FDA rejection, and are leaning solely on its publicity campaign. Open letters from about 200 health professionals argue that the drug is little better than a placebo and doesn't warrant the risk posed by the side effects.

"Approving flibanserin will not only unleash an unsafe drug onto the U.S. market, but will send a message to industry that pressuring the FDA through public relations campaigns can get a drug approved," wrote Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center. Fugh-Berman questioned whether the subjects in the flibanserin study were truly experiencing a medical issue, as opposed to natural fluctuations in libido caused by aging or other external factors.

An FDA analysis revealed that women who experienced two to three "satisfying sexual events" per month before taking the drug were increasing that total by an average 0.5 to 1 per month after beginning use of flibanserin.

Fugh-Berman noted that flibanserin can cause serious side effects: increased risk of fainting, low blood pressure, dizziness and sleepiness. She also contends that the drug has the sedative power of four alcoholic drinks.

On its website, Even the Score criticizes the FDA for approving Viagra and other drugs that improve men's sex lives, while no approved drugs exist for women. The FDA counters by saying that Viagra is a treatment for erectile dysfunction (which only requires improved blood flow), not low libido. Unlike Viagra, which men take before sex, women would take flibanserin every day for the rest of their sex lives.

UPDATE: On Tuesday, flibanserin won approval from the FDA. Whitehead says that the pill should hit the market by Oct. 17, 2015 under the brand name Addyi.