Effects of female libido drug unknown, advocacy group warns

June 24, 2019

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A women’s health organization is concerned about the safety and effectiveness of bremelanotide (Vyleesi) after FDA approved it to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.

Santilli

The National Women’s Health Network (NWHN) is urging women to avoid using Vyleesi (AMAG Pharmaceuticals) until more is known about its safety and effectiveness.

"Women simply do not have enough information to make an informed decision about whether the drug is safe and effective. The FDA did not call on their advisers to review the drug publicly, and the sponsor has not yet published full clinical trial results,” NWHN said in a statement.

However, FDA said in a statement that its approval was based on 2, 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD. In the trials, around 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire), compared to about 17% of those who took placebo.

In addition, around 35% of the patients treated with Vyleesi had a decrease of one or more in their distress score (scored on a range of zero to four, with higher scores indicating greater distress from low sexual desire), compared to about 31% of those who took placebo. There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events and Vyleesi does not enhance sexual performance, FDA noted.

“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. Today’s approval provides women with another treatment option for this condition,” said Hylton V. Joffe, MD, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

AMAG estimates that Vyleesi could produce has $1 billion in revenue, John Santilli, president of Market Access Intelligence, told FormularyWatch, while GlobalData estimates that the drug will produce $810 million in sales in 2024. “It is estimated that perhaps 1% of HSDD patients will use it. AMAG estimates that the prevalence of HSDD among premenopausal women to be 10%,” Santilli said.

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Still, the uptake of the drug is expected to be low in the first couple of years, Santilli noted.

And the limited data published on the drug leaves many important questions unanswered, according to NWHN. “For example, it appears that hundreds of women enrolled in the pivotal trials were not included in the company’s presentation of the results. What happened to those women?,” NWHN said.

FDA approved flibanserin, the first drug in this class, without requiring its sponsor to fulfill all of the required safety studies-and despite minimal effectiveness, Cynthia A. Pearson, executive director of NWHN, told FormularyWatch. “Without a public presentation of the data, we don't know if the FDA has succumbed to pressure and approved another bad drug.”

FDA noted that the common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions, and headache. In the clinical trials, Vyleesi increased blood pressure after dosing, which usually resolved within 12 hours. “Because of this effect, Vyleesi should not be used in patients with high blood pressure that is uncontrolled or in those with known cardiovascular disease. Vyleesi is also not recommended in patients at high risk for cardiovascular disease,” FDA said.

In addition, when naltrexone is taken by mouth, Vyleesi may significantly decrease the levels of naltrexone in the blood. “Patients who take a naltrexone-containing medication by mouth to treat alcohol or opioid dependence should not use Vyleesi because it could lead to naltrexone treatment failure,” FDA noted.