Flushing, injection site reactions and headache are other common side effects of the new FDA-approved drug called Vyleesi.
Vyleesi, a new drug to boost low sex drive in women has been approved in the US by the Food and Drug Administration. Women can given the drug to themselves in the thigh or abdomen that raises their sexual interest for several hours.
The drug developed by Amag Pharmaceuticals is considered to act on receptors for a brain-stimulating hormone called melanocortin, which is associated with sexual arousal and appetite in both men and women.
While on the positive side, the drug is to be used “only when you need it”, on the downside, “its a shot” causing side effects like nausea. Dr Julia Johnson, a reproductive specialist at UMass Memorial Medical Center who was not involved in its development said, “The downside is that it’s a shot — and some people are very squeamish.”
The FDA-approval came in the backdrop of premenopausal women (with a disorder defined by a persistent lack of interest in sex, causing stress) responses to questionnaires that showed increases in sexual desire and decreases in stress related to sex. However, the women didn’t report having more sex which was the original goal for the drug.
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 reportedly. It also could interfere with oral naltrexone, a drug for people with alcohol and opioid dependence, the FDA further 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.
Interestingly, 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.
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.” But the company declined to release price information.
Amag’s campaign has some of the hallmarks that helped launch the first female libido drug, Addyi, a once-a-day pill approved in 2015. The FDA decision followed a contentious four-year review that included a lobbying effort funded by Addyi’s maker, Sprout Pharmaceuticals, which framed the lack of female sex drugs as a women’s rights issue.
Women taking Addyi showed a slight uptick in “sexually satisfying events” per month and improved scores on psychiatric questionnaires. Those results were only slightly better than what women taking a placebo reported, but they were significant enough to meet FDA effectiveness standards.
ALSO READ: Why Addyi, billed as ‘female Viagra’, is not really a wonder drug
The pink pill — originally developed as an antidepressant — was ultimately approved with a bold warning that it should not be combined with alcohol, due to risks of fainting and dangerously low blood pressure.
Most insurers refused to cover the drug, citing lackluster effectiveness, and many women balked at the $800-per-month price. Last year, Sprout slashed the price to $400. It was prescribed just 6,000 times last year, according to investment analyst data.
UMass’s Johnson said drugs should not be the first choice for treating women’s sexual problems. Instead, she recommends counselling to help women “separate all the stresses of life” from their sex life.
“But if that doesn’t work, having a medication that may help is worth trying,” Dr Johnson said.
(With inputs from AP)
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