The U.S. Food and Drug Administration has approved bremelanotide (Brand Name: Vyleesi) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Bremelanotide is supposed to increase women’s libido, and is injected with a pen about 45 minutes ahead of time. Approval of Bremelanotide has been granted to AMAG Pharmaceuticals. It will be available in US by September 2019. Bremelanotide does not enhance sexual performance.
Bremelanotide is the 2nd drug approved by USFDA for HSSD after Flibanserin. The drug flibanserin, sold as Addyi by Sprout Pharmaceuticals, was approved in August 2015. However, in the wake of both fanfare and controversy, the drug has not been not widely used, in part because women couldn’t take it with alcohol and health care providers had to be specially certified to prescribe it.
“Based on our data, we don’t have an interaction with alcohol, so we don’t believe there will be a restriction,” Dr. Julie Krop, chief medical officer of AMAG Pharmaceuticals, said of Vyleesi.
Another difference between the drugs is that Addyi, an oral tablet, is taken once daily, whereas patients can take bremelanotide as needed, Krop added.
HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship or the effects of a medication or other drug substance. Acquired HSDD develops in a patient who previously experienced no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.
“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. Approval provides women with another treatment option for this condition,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.
Bremelanotide activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown. Patients inject Bremelanotide under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity and may decide the optimal time to use Bremelanotide based on how they experience the duration of benefit and any side effects, such as nausea. Patients should not use more than one dose within 24 hours or more than eight doses per month. Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.
The effectiveness and safety of Bremelanotide were studied in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD. Most patients used Bremelanotide two or three times per month and no more than once a week. In these trials, about 25% of patients treated with Bremelanotide 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. Additionally, about 35% of the patients treated with Bremelanotide 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.
The most common side effects of Bremelanotide are nausea, vomiting, flushing, injection site reactions and headache & rarely darkening of the gums and parts of the skin, including the face and breasts, which did not go away in about half the patients after stopping treatment.
Bremelanotide is contraindicated patients with high blood pressure that is uncontrolled or in those with known cardiovascular disease. Bremelanotide is also not recommended in patients at high risk for cardiovascular disease.
In patients taking naltrexone orally for alcohol or opioid dependence, Bremelanotide may significantly decrease the levels of naltrexone in the blood leading to treatment failure.
In 2012, the FDA identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention. The FDA held a two-day meeting in October 2014 to advance the agency’s understanding of female sexual dysfunction. During the first day of the meeting, the FDA solicited perspectives directly from patients about their condition and its impact on daily life. In 2016, the FDA published a draft guidance titled “Low Sexual Interest Desire and/or Arousal in Women: Developing Drugs for Treatment,” to assist companies developing drugs for the treatment of these conditions.