An as-needed injectable treatment offers women another option for treating low libido, but it may not work for every woman.
Women have another FDA-approved drug that promises to boost their sex drive, bringing the total number of medications to exactly… two.
The drug called Vyleesi was developed by AMAG Pharmaceuticals Inc. The company plans to sell the drug at $899 for a pack of four injectors, according to Reuters.
There is no information available yet on whether the drug will be covered by health insurance. But Reuters reports that some plans cover Addyi, the first female low libido drug on the market. This daily pill was approved in 2015.
Women inject the new drug themselves in the thigh or abdomen using an auto-injector. The medication works for several hours and only has to be used when women need it.
“Bremelanotide, or Vyleesi, is the first option available to women that allows them to treat their symptoms on an as-needed basis,” said Dr. Elizabeth Kavaler, a urology specialist at Lenox Hill Hospital in New York City who wasn’t involved in the drug’s development. “The injection is self-administered 45 minutes before the desired effect occurs.”
The Food and Drug Administration (FDA) approved bremelanotide on Friday for premenopausal women with hypoactive sexual desire disorder (HSDD). This condition is defined by a low level or absence of interest in sex, causing distress or relationship difficulty.
AMAG conducted two clinical trials with over 1,200 women to study how well bremelanotide worked. Women were randomly assigned to use either the drug or an inactive placebo.
In addition, over a third of women treated with bremelanotide had decreases in self-reported distress related to low sex drive. However, this was only slightly higher than the number of women in the placebo group who saw improvements.
Women using the drug had a similar number of satisfying sexual events during the study as women who took the placebo.
Bremelanotide doesn’t enhance sexual performance, said the FDA.
The most common side effects of bremelanotide were nausea, vomiting, flushing, headache, and reactions at the site of injection.
The FDA reported that about 40 percent of women in the clinical trials experienced nausea, sometimes severe enough that they needed a medication to treat it.
Blood pressure also increased in women using bremelanotide, although it usually returned to normal within 12 hours. However, women with unmanaged high blood pressure or cardiovascular disease shouldn’t use the drug.
Bremelanotide may also interfere with naltrexone, a drug taken by mouth to treat opioid or alcohol dependence. People taking naltrexone shouldn’t use bremelanotide.
The drug activates melanocortin receptors in the body. These are known to be involved in
Kavaler said, “The results of this study are promising, and so far, this is the safest option for women that is available, with the benefit of being used only when needed.”
Previous studies estimate that between 8 and 19 percent of pre- and postmenopausal women have hypoactive sexual desire disorder. The exact cause isn’t always known.
“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” said Dr. Hylton V. Joffe, a director in the FDA’s Center for Drug Evaluation and Research, in a news release.
“Today’s approval provides women with another treatment option for this condition.”
The Associated Press reports that AMAG plans on promoting the drug through social media, including on a website called unblush.com that’s aimed at raising awareness of hypoactive sexual desire disorder.
This marketing is similar to what was used to launch Addyi.
The FDA recently raised concerns about this once-a-day pill, saying that it’s not safe to take with alcohol. As a result, sales of the drug have stagnated. The AP reports that Addyi was only prescribed 6,000 times last year.
Whether or not Vyleesi shares a similar fate remains to be seen.
“We will not truly understand the market for a medication like this until it becomes available and women learn about it,” said Kavaler.
Low libido in women can have a number of causes, with treatment depending on what’s behind the loss of interest in sex. Some women may benefit from medication or hormone therapy, while others may see better results with counseling.
Although the drug may not work for every woman, its presence on the market — and AMAG’s marketing efforts — may encourage more women to talk to their doctors about this topic.
“The availability of Vyleesi can provide an opportunity for physicians to ask their female patients about their sexual satisfaction and desire,” said Kavaler. “Having an option to offer women gives doctors confidence to bring this delicate subject up with our patients.”