Women May Get New Drug for Low Sex Drive—and More Controversy

(Bloomberg) -- U.S. health regulators approved a second drug to treat low sexual desire in women, adding another option to an area of medicine that’s become better known for controversy than for blockbuster sales.

The drug, bremelanotide, will be marketed by Amag Pharmaceuticals Inc. under the brand name Vyleesi, the FDA said in an email. It’s a shot that comes in an auto-injecting pen that premenopausal women would use about 45 minutes before sex. Sprout Pharmaceuticals Inc.’s Addyi, a pill taken daily, became the first female libido drug to gain Food and Drug Administration clearance in 2015.

Palatin Technologies Inc., which developed the new drug, will receive as much as $300 million from an agreement that gives Amag the rights to sell it. Amag shares gained as much as 12% in late trading after the market closed in New York. Palatin rose as much as 65%.

Amag says Vyleesi will appeal to women who don’t want to take a drug every day. Women in clinical trials used the shot on average three times a month, according to Chief Executive Officer William Heiden. A spokeswoman for the company said it plans to start selling the drug in September and will announce its price closer to the launch.

Vyleesi’s path to market was smoother than Addyi’s, which has a modest effect on sexual desire and faced public detractors who doubted whether women need a drug for the condition.

In clinical trials, the FDA said about 25% of patients treated with Vyleesi benefited from an increase in sexual desire score, compared with about 17% who took a placebo. About 40% of patients in clinical trials experienced nausea, most commonly in those who used the drug, and 13% needed medications to treat the side effect, the FDA said in a statement.

“There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events,” according to the FDA statement.

The FDA didn’t call on its advisers to debate the drug’s merits publicly, and Amag hasn’t yet published full clinical trial results. The agency often holds advisory meetings when a new type of drug like Vyleesi is coming to market, but not always.

Vyleesi aims to treat a condition known as hypoactive sexual desire disorder, which is low libido that causes distress. About 6% to 10% of women of child-bearing age could be characterized as having HSDD, said Sharon Parish, a professor of clinical psychiatry at Weill Cornell Medical Center who treats women with the condition.

The shot works by increasing dopamine, a chemical in the brain related to sexual responsiveness, said David Portman, director emeritus at the Columbus Center for Women’s Health Research in Ohio, who helped Amag with studies of the drug.

“A significant number of women haven’t sought treatment,” Portman said. “Having more options is a way for women to come in to providers and ask what treatment is right for them.”

Not Enough

In clinical trials, Sprout’s Addyi offered meaningful help for about 10% more patients than a placebo. Some women’s health advocates said that wasn’t enough, given that side effects include fainting and extreme sleepiness. Addyi originally carried a ban on alcohol consumption, which has since been eased. Vyleesi doesn’t carry any similar limits on alcohol.

It’s unclear how many women could be helped by Vyleesi without the full clinical trial results being published. About 20% of women dropped out of trials, Portman said, including 8% who discontinued due to nausea.

Addyi has seen a jump in its sales this year as startups selling sexual-wellness drugs online, including Hers, take off. Total prescriptions for the pill increased more than 400% in May compared with the same month last year, totaling 3,000, according to data compiled by Bloomberg Intelligence. By contrast, a million Viagra prescriptions for men are sold every month.

“That market was totally created by marketing beforehand and women didn’t flock to that at all,” said Adriane Fugh-Berman, director of PharmedOUT at Georgetown University Medical Center, a program that supports evidenced-based prescribing. “I don’t think they’ll flock to this either. They’re smarter than that.”

Facing Backlash

After the FDA rejected Addyi for its modest effect in 2013, the agency faced a backlash from doctors and researchers who claimed the agency was sexist. Women, many brought in by the pill’s maker, Sprout, flocked to the FDA’s headquarters two years later to argue for Addyi’s approval as the agency gathered outside experts in a public meeting to consider the drug.

“In this case specifically, I think women really need the FDA not only to do a careful vetting but to share the summary of that vetting with them,” said Cindy Pearson, executive director of the National Women’s Health Network. The group urged women not to use Vyleesi until more is known about its safety and effectiveness.

Amag started an unbranded social media campaign called “unblush” on Instagram and Facebook earlier this year to talk about hypoactive sexual desire disorder. Heiden, the CEO, said one of its promoted posts had 2.8 million views and that 80,000 people clicked through to get more information. The campaign will transition to a branded one now that Vyleesi is approved, Heiden said.

The Waltham, Massachusetts-based company doesn’t plan to do television ads because its target audience isn’t watching much TV, he said.

To contact the reporters on this story: Anna Edney in Washington at aedney@bloomberg.net;Cynthia Koons in New York at ckoons@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet, Timothy Annett

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