U.S. women will soon have another drug option designed to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours.
The medication OK’d Friday by the Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. The other drug is a daily pill.
The upside of the new drug “is that you only use it when you need it,” said Dr. Julia Johnson, a reproductive specialist at UMass Memorial Medical Center who was not involved in its development. “The downside is that it’s a shot — and some people are very squeamish.”
The drug’s developer, Amag Pharmaceuticals, could also face some of the same hurdles that have plagued the lone pill previously approved for the condition, including unpleasant side effects and limited insurance coverage. The company declined to release price information.
The FDA approved the new drug, Vyleesi (pronounced vie-LEE’-see), for premenopausal women with a disorder defined by a persistent lack of interest in sex, causing stress. The most common side effect in company studies was nausea. The approval was based on women’s responses to questionnaires that showed increases in sexual desire and decreases in stress related to sex. The women didn’t report having more sex, the original goal for the drug.
“Women are not desiring more sex. They want better sex,” said Dr. Julie Krop, Amag’s chief medical officer.
Flushing, injection site reactions and headache are other common side effects.
Women with high blood pressure or heart disease should not take the drug because increases in blood pressure were observed after injections, the FDA said. It also could interfere with oral naltrexone, a drug for people with alcohol and opioid dependence, the FDA said.
Because so many factors affect sexual desire, doctors must rule out other causes before diagnosing the condition, including relationship issues, medical problems and mood disorders. The condition, known as hypoactive sexual desire disorder, is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.
Still, the pharmaceutical industry has long pointed to surveys — some funded by drugmakers — suggesting that it is the most common female sexual disorder in the nation, affecting roughly 1 in 10 women. Amag estimates nearly 6 million U.S. women meet the criteria for the drug.
Cynthia Pearson, executive director of the National Women’s Health Network, urged women to avoid using the drug “until more is known about its safety and effectiveness.” She noted in a statement that Amag had not yet published full clinical trial results.
The search for a pill to treat women’s sexual difficulties was once a top priority for many of the world’s biggest drugmakers, including Pfizer, Bayer and Procter & Gamble. Those companies and others studied and later abandoned drugs acting on blood flow, testosterone and other targets.
Vyleesi acts on receptors for a brain-stimulating hormone called melanocortin, which is associated with sexual arousal and appetite in both men and women.
Waltham, Massachusetts-based Amag plans to pitch the drug to consumers through social media, including a website called unblush.com that tells women that low sex drive “is nothing to blush about.”
Topic: US Approved New Drug to Boost Women's Sex Drive (Read 19754 times)
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March 12, 2018, 07:27:32 AM