Headache? There's a Pill for That!

"It's a mismatch of models."
"They want the car repair model: 'Hello, doctor, I've got this carburetor that doesn't work in my car. Could you fix it for me without talking to me?' It's laughable."
Leonore Tiefer, sex therapist, New York

"[The debate over HSDD -- hypoactive sexual desire disorder -- is] an old argument that there's no point in having any more."
"Lighting a candle and having a glass of wine isn't helpful for these women, just as going to see a funny movie isn't helpful for someone who's depressed."
Dr. Sharon Parish, sexual medicine, New York-Presbyterian Hospital

"[What women diagnosed with HSDD need] is not medical treatment, but a thoughtful exploration of what creates desire between them and their partners."
Emily Nagoski, sex educator, author

"We're not trying to prescribe a one-size-fits-all desire."
"It's about empowering women to have the choice and the ability to restore their desire where they think it's been robbed."
Dr. Julie Krop, chief medical officer, AMAG Pharmaceuticals

The FDA has approved Vyleesi, a new medication for pre-menopausal women with female hypoactive sexual desire disorder, or HSDD. (Peter Cade/Getty Images)

A marketed treatment for hypoactive sexual desire disorder in women is in the marketplace, one that the U.S. Food and Drug Administration approved in 2015. In pill form, it is called Addyi. When it was introduced debate followed whether sexual desire was to be considered a medical issue at all. Since then, Addyi has languished in sales, largely because women may not drink alcohol before taking it. Although its introduction to the marketplace caused a huge furore, when it became known it came with severe restrictions, its sales fizzled.

Now another drug formula, bremelanotide, has now been approved by the FDA, and a similar storm of controversy has erupted. AMAG Pharmaceuticals, which produces this new drug called Vyleesi has high hopes of a wild sales coup, similar to that seen when Viagra for erectile dysfunction in men was introduced to the consumer market. Bremelanotide has an effect similar to Addyi, absent many of its side effects.

"Sexual disorder" of low sex drive is a common condition, with an estimated one in ten women reporting HSDD. But not everyone can use the drug; it is definitely not recommended for women with high blood pressure or heart disease. And while stress is certainly known to play a part in low  sex drive, we live in a stressful world. The drug doesn't come cheap and insurers are not known to cover it.

Its price originally was set at $800 monthly but as a result of women balking at that price, it was slashed down to $400. The drug stimulates hormones called melanocortin, associated with sexual arousal and appetite for both genders. It now joins once-a-day Addyi as the second female libido medication on the market.And one wonders how many women will appreciate that Vyleesi must be injected, not swallowed.

As for its efficacy, despite that many doctors claim the drug would represent a solution to a real need for thousands of women, its demonstrated effects have been recognized as relatively modest. By many others, its creation and marketing is considered as yet another instance of pharmaceutical overreach with its on-demand therapy for HSDD.

AMAG claims that desire is governed by a compromise between excitatory and inhibitory neurons, that women with HSDD are imbalanced toward inhibition, so that bremelanotide, targeting an excitatory receptor, melanocortin 4, has the effect of moderating the situation, reducing distress and increasing desire. Self-administered through a tiny needle slipped under the skin of the thigh or abdomen, the drug underwent clinical trials with over 1,200 women.

Bremelanotide decreased distress by one point from baseline on a four-point scale and at the other end, in desire increase, the results were more modest, the median patient experiencing an improvement of a mere .6 from baseline on a scale ranging from 1.2 to 6. That level of improvement, according to AMAG is sufficient to achieve real benefit for women with HSDD.

A doctor must rule out every other possible cause of a woman's waning sex drive; whether relationship-associated, or the side effects of another medication, or the impact of a surgery -- before the woman can be diagnosed with HSDD, and bremelanotide prescribed. And then, only 25 percent of women using the drug responded well to its effects.

As for probable and potential side effects, the most common is nausea, reported in 40 percent of women -- as well as vomiting, flushing, injection site reactions and headaches. Leading one to doubt the value of its usefulness; not much going for it, after all...

"We’re obviously thrilled about being able to bring another option to patients."
"These women have suffered significantly, pretty much in silence, for a stigmatized condition, and many of them have not known that it’s a treatable medical condition."
Dr. Julie Krop, chief medical officer, AMAG

Oh, and according to psychologist Lori Brotto, director of the University of British Columbia's sex health laboratory, no  definitive scientific proof exits that low sexual desire in women is caused by aberrant brain chemistry. Good evidence exists, however, that the mind-body nexus provides the key to female sexuality, and having a physiological explanation for a condition may lead many people to search out help for a problem that might otherwise have been dismissed.

This image provided by Amag Pharmaceuticals in June 2019 shows packaging for their drug Vyleesi. The medication OK'd Friday, June 21, 2019 by the U.S. 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. (Amag Pharmaceuticals via AP)