“Female Viagra” Gets Approved By The FDA

A new drug acclaimed as being the new “female Viagra” was approved by the US Food and Drug Administration (FDA) on Friday, June 21.

While it may prove to be a welcome answer for some women suffering Hypoactive Sexual Desire Disorder (HSDD), its approval has not escaped controversy.

Vyleesi, manufactured by AMAG Pharmaceuticals and known scientifically as bremelanotide, is the second drug approved to treat low sexual desire in females, after the 2015 launch of the drug Addyi.

The newly approved drug – Vylessi – differs from Addyi because it is administered via injection at least 45 minutes before sexual activity, as opposed to a daily pill.

hand holding pills

Addyi has proven disappointing in both sales and efficacy; even more concerning is that the FDA continues to warn patients about the safety concerns regarding the drug; however, they relaxed some labelling restrictions this year.

With Vyleesi set to be available in September, experts are arguing that female desire is over-medicalised and that alternative methods may be a better and safer way to boost it.

Dr. Anne Katz, a Canadian sexuality counsellor, says, “Desire is a complex issue that, as the science has shown, is not something that is an easy fix. Addyi is a failure. I suspect this one will be too.”

The FDA’s own data – which was used to make its decision to approve Vylessi – doesn’t sound very impressive either. After trials involving 1,200 women with HSDD, about 25 per cent of patients who took Vylessi reported an increase in their sexual desire. Only slightly more than 17 per cent of patients who took a placebo and described the same effect.

Woman on man in bed

The modest results highlight what Dr. Katz and many other experts have suggested, that female desire is more complicated than merely addressing biological anomalies, and is intricately related to several other reasons including life circumstances, stress, interpersonal relationships, and other factors.

In addition to showing only minor improvements in sexual desire, it is worth noting that 40 per cent of the participants experienced nausea after taking the drug, and 18 per cent of women dropped out of the trial, of which 8 per cent stopped because of nausea. While approximately 1 per cent of participants reported darkening in their gums and parts of their skin, which didn’t resolve in around half of the women even after they stopped taking the drug.

The drug is not suited to people with high blood pressure or cardiovascular disease. Another downside is that patients are not advised to use Vyleesi more than once a day or more than eight times a month. Perhaps many women will find that is sufficient; however, it is restrictive for those who want to have sex more regularly.

Female Libido Pills

Not a lot is known about how “female Viagra” works, but, not all experts are unenthusiastic about the potential of Vyleesi. Dr. Leah Millheiser, director of the Female Sexual Medicine Program at Stanford Health Care, argues,  “The argument that this is not a biological issue, this is a lifestyle issue, is completely misguided.”

Millheiser says that her research on Hypoactive Sexual Desire Disorder (HSDD) shows that women with the condition do indeed experience changes in brain activity free of other contributing factors. She says that biological and lifestyle factors must both be addressed.

But, the debate around HSDD and the drugs billed as Viagra for women doesn’t look like it will go away anytime soon.

While Millheiser agrees that Vyleesi’s clinical trial results aren’t great, she says even a small improvement can positively impact some patients. On the other side of the argument, others believe the drug is an opportunistic attempt from big pharma to capitalise on an issue that goes much deeper.