The medicine has to be administered as an injection into the thigh or abdomen with an auto-injector at least an hour before sexual activity.
Vyleesi is clearly not the female equivalent of Viagra but the US Food and Drug Administration has approved a second drug that will be marketed as improving the sexual desire in a woman.
Vyleesi has been approved to be prescribed to premenopausal women with a disorder defined by a persistent lack of interest in sex, causing stress. Hypoactive Sexual Desire Disorder (HSDD) is characterised by low or no libido.
“A place for women to speak up and get answers about low sexual desire that frustrates us,” the website declares.
Viagra was approved for medical use in the US and Europe back in 1998 and drug companies have been feverishly working on a female version. Addyi, manufactured by Sprout Pharmaceuticals and approved in August 2015, was marketed as the female version of Viagra, a Pink Viagra – but that comparison was quickly dismissed.
“Unfortunately, Addyi did not meet the expectations of most women. It did not match the extremely strong supremacy of Viagra. The drug comes with certain limitations; for instance, it cannot be taken with alcohol and it has to be taken on a daily basis,” writes My Health Click.
One positive of Vyleesi “is that you only use it when you need it,” Dr Julia Johnson, a reproductive specialist at UMass Memorial Medical Centre in Worcester, Massachusetts, who was not involved in the development of Vyleesi, told AP News.
“The downside is that it’s a shot — and some people are very squeamish,” Johnson said.
The sex drug has to be injected into the abdomen or thigh at least an hour before sexual activity.
The medication acts on the receptors of melanocortin, a brain-stimulating hormone associated with sexual arousal and libido in all genders.
The drug has to be administered as an injection into the thigh or abdomen with an auto-injector at least an hour before sexual activity. Like Viagra, Vyleesi should not be taken more than once in any 24-hour period. Also, it should not be taken more than 8 times per month.
Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress, the US FDA stated in its approval.
“Women are not desiring more sex. They want better sex,” said Dr Julie Krop, Amag’s Chief Medical Officer.
Possible side effects of Vyleesi include nausea, flushing, injection site reactions and headache.
The drug is not recommended for women with high blood pressure or heart disease and it is also contraindicated for use with oral naltrexone, a drug for people with alcohol and opioid dependence, the FDA said.
Cynthia Pearson, Executive Director of the National Women’s Health Network, urged women to avoid using Vyleesi “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.
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.”
Amag’s campaign is similar to the one 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 increase in “sexually satisfying events” per month and improved scores on psychiatric questionnaires. Those results were only slightly better than those taking a placebo reported, but they were significant enough to meet FDA effectiveness standards.
Most insurers refused to cover the drug, citing lacklustre effectiveness, and many women baulked at the A$800-per-month price. Last year, Sprout slashed the price to A$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 sexual problems. Instead, she recommends counselling to help “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,” she said.
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