The Food and Drug Administration's approval Tuesday of the first-ever drug to increase sexual desire in women is being viewed by some as a major victory for gender equality, and for patients with a complex disorder that is often overlooked.
But with the arrival of Sprout Pharmaceuticals' drug Addyi come questions about how physicians approach health issues that involve women's low sexual desire.
Supporters say the attention focused on Addyi's approval has helped highlight hypoactive sexual desire disorder (HSDD), a condition that affects between 5% and 10% of women, according to Dr. Holly Thomas, an assistant professor of medicine at the University of Pittsburgh.
“I think it was the right move on the part of the FDA to approve the drug, given that the treatment options have been somewhat limited for women,” Thomas said.
The once-a-day pill is prescribed to increase sexual desire, as well as to improve satisfaction in sexual activity for women diagnosed with HSDD. The disorder is characterized by low sexual desire over a prolonged period that causes distress and cannot be attributed to other factors, such as a co-existing medical or psychiatric condition, or another prescription's side effects.
Treatment for the condition, which some doctors even dismiss as being a medical problem, has been limited. Some physicians prescribe testosterone creams to boost libido.
Addyi was previously used as an antidepressant, which won't come as a surprise to those who say female sexual desire involves the brain more than the genitals.
The medication, generically known as flibanserin, acts on chemicals in the brain that affect mood and appetite.
An FDA advisory panel recommended the drug for approval in June by a vote of 18-6, despite clinical trial results that showed women taking flibanserin reported having an average of .5 to 1 additional sexually satisfying event per month, with between 8% and 13% experiencing improvement over those who took a placebo.
Potential side effects include low blood pressure, temporary loss of consciousness and drowsiness; those risks are increased when women drink alcohol or take certain drugs, including birth control pills.
Because of the added risks to those who drink, the FDA has added a box warning to the drug, and it can only be prescribed by physicians who are certified under the agency's risk-evaluation and mitigation-strategy program, which requires doctors to undergo training on how to counsel patients about the importance of abstaining from alcohol while taking the drug.
An analysis of flibanserin, published in JAMA in July, found that, in its latest regulatory review, Sprout presented no additional data to prove the drug's effectiveness. http://jama.jamanetwork.com/article.aspx?articleid=2389384
The article noted the launch of an advertising campaign after the drug received its second rejection in 2013 called “Even the Score,” which framed the debate over the drug's approval as one of gender equality.
On its website, the ad campaign, which lists more than a dozen women's health advocacy groups, as well as Sprout as supporters, claimed there have been no FDA-approved drugs to treat women's sexual dysfunction, while the agency has approved 26 treatments for men.
“We believe that women have the right to make their own informed choices concerning their sexual health; that gender equality should be the standard in access to sexual dysfunction treatments; and that the approval of safe & effective treatments for low desire should be a priority for the FDA,” the site stated.
Opponents say the drug's approval, most notable because of a large-scale lobbying campaign spearheaded by Sprout, along with a number of health-advocacy groups, sets a bad precedent that they fear could lead other pharmaceutical firms to employ similar tactics for drugs that show marginal benefit but have real safety risks.
“The FDA has crossed a bridge that they cannot now go back on,” said Cynthia Pearson, executive director for the National Women's Health Network, a not-for-profit advocacy organization based in Washington, D.C. “It signals to other companies that if you get turned down, your data are insufficient, and safety questions aren't answered, rather than following a rigorous science-based course to finally win approval, you can go another route.”
Yet others feel the FDA followed the right course of action in approving Addyi when looked at from the perspective that, despite lobbying campaign concerns, the drug has been proven to show improvement in some women who took it, compared to those who took a placebo. Since its labeling warns of its potential side effects, the onus to ensure safety in taking the drug falls on physicians and patients, said Dr. Walid Gellad, associate professor of medicine at the University of Pittsburgh and co-director of the Center for Pharmaceutical Policy and Prescribing.
“This is about drug approval, and the drug met its endpoint, and is statistically superior to placebo,” said Gellad, who was one of JAMA article's authors. “You can make an argument on both sides on whether the drug's efficacy is enough, depending on how bad you think the condition is you're treating.”