Coverage: Women’s libido pill gains regulatory approval

In a big, and potentially controversial, move Tuesday, the Food and Drug Administration approved for the first time a pill designed to boost women’s libidos.

The New York Times’ Andrew Pollack summed up the decision:

The first prescription drug to enhance women’s sexual drive won regulatory approval on Tuesday, clinching a victory for a lobbying campaign that had accused the Food and Drug Administration of gender bias for ignoring the sexual needs of women.

The drug — Addyi from Sprout Pharmaceuticals — is actually the first drug approved to treat a flagging or absent libido for either sex. Viagra and other drugs available for men are approved to help achieve erections, or to treat certain deficiencies of the hormone testosterone, not to increase desire.

Advocates who pressed for approval of Addyi, many of them part of a coalition called Even the Score, said that a drug to improve women’s sex lives was long overdue, given the many options available to men.

“This is the biggest breakthrough for women’s sexual health since the pill,” said Sally Greenberg, executive director of the National Consumers League.

But critics said the campaign behind Addyi had made a mockery of the system that regulates pharmaceuticals and had co-opted the women’s movement to pressure the F.D.A. into approving a drug that was at best minimally effective and could cause side effects like low blood pressure, fainting, nausea, dizziness and sleepiness.

In announcing the approval, Dr. Janet Woodcock, a senior F.D.A. official, said the agency was “committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

The F.D.A. decision on Tuesday was not a surprise since an advisory committee of outside experts had recommended by a vote of 18 to 6 in June that the drug be approved, albeit with precautions required to try to limit the risks and ensure that it was not overused.

The Wall Street Journal’s Thomas Burton discussed the pill’s effectiveness, writing:

An FDA analysis also found that women taking Addyi and hormonal contraceptives “tended to have a higher incidence of adverse events” compared with those on a contraceptive and placebo. The FDA’s analysis of the drug’s safety found “serious risks of hypotension and syncope,” meaning low blood pressure and fainting.

To measure the drug’s effectiveness, the FDA looked at users’ self-reports of “satisfying sexual events,” which initially were at a median average of about two to three a month per person. Addyi users had a median increase, compared with placebo users, of 0.5 to one such event a month, an FDA analysis found.

As to whether this conveys a perceivable benefit to those taking the drug, Cindy Pearson, executive director of the National Women’s Health Network, said women in the study had “about one more time a month where they’re happy. That’s pretty crummy.”

Jason deBruyn of the Triangle Business Journal discussed criticisms about the pill faced by the Raleigh, North Carolina-based company, Sprout Pharmaceuticals, which produces it:

Although the company has critics, they have backers as well, including Even The Score, a campaign for women’s sexual health equality. These groups point out that there are 26 approved drugs for male sexual disorders, but none for disorders in women. Approximately one in three women in the United States suffers from low sexual desire, and one in 10 women, or about 16 million women total, is distressed by it, according to Sprout.

Still, critics’ concerns are at least partly rooted in previous behavior, when the Whiteheads ran afoul of the FDA’s rules.

The Whiteheads previously operated Slate Pharmaceuticals, which produced testosterone pellets marketed under the name Testopel. The FDA ruled that advertising and marketing for Testopel was “misleading” on several fronts, including that they overstated the efficacy of the drug while minimizing important risk information, omitted material facts and presented misleading convenience claims, according to an FDA warning letter dated March 24, 2010.

“We are extremely concerned by the breadth and scope of violations reflected in your promotional materials,” FDA wrote in its warning letter. “The presentations seen throughout the cited pieces suggesting that Testopel is safer and more effective than has been demonstrated are very problematic from a public health perspective given the limited indication of the drug and its risk profile.”

Critics fear the same could happen with Addyi, especially given its list of side effects. An Associated Press report highlighted some of those concerns.

Toni Clarke and Ransdell Pierson of Reuters detailed the strict warnings that will come attached to the pink pill:

Addyi will come with a prominent “boxed warning” about side effects, including among people with liver impairment or who take Addyi with alcohol or with medicines known as CYP3A4 inhibitors that include certain steroids.

Originally developed by Germany’s Boehringer Ingelheim under its chemical name flibanserin, it was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks. Sprout acquired the drug, conducted additional studies and resubmitted the application. In 2013, the FDA rejected it again.

The rejection sparked a lobbying campaign by Sprout, aided by some women’s groups who accused the FDA of gender bias because it had approved Viagra for men – a charge the FDA vigorously rejected.

The FDA approved Addyi despite a rocky relationship in recent years with the founders of Sprout.

The chief executive of Sprout, Cindy Whitehead, co-founded the company with her husband Robert Whitehead in 2011 after selling another small drugmaker they had founded called Slate Pharmaceuticals which had received repeated warnings from the FDA about its marketing tactics.

Slate marketed an implantable testosterone pellet for men with low levels of the male sexual hormone, called Testopel.

In one FDA warning letter, issued on March 24, 2010, the FDA said Slate had improperly inferred on its Testopel website and in a video that the testosterone product could help patients with depression, erectile dysfunction, diabetes and HIV.

The Whiteheads could not be reached for comment late on Tuesday about Addyi’s approval and their earlier encounters with the FDA.

Anna Edney of Bloomberg wrote about Sprout Pharmaceuticals potential competition:

About 2 million women are currently seeking treatment for the disorder and more are expected to come forward once Addyi is on the market, said Carl Spana, CEO of Palatin Technologies Inc., which is developing its own female sex-drive treatment.

Palatin is in the final stages of testing its drug bremelanotide for use as needed, like Viagra, while Addyi is taken every night before bed. Palatin estimates the market for low female sexual desire treatments could total $1.3 billion a year, based on the 2 million women known to be affected.

Palatin could bring bremelanotide to market in early 2018, Spana said. The company has had talks with larger drugmakers, which he declined to name, that would likely license bremelanotide for sale.