New Rx for Women Gets Green Light Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) has approved a medication for low sexual desire in women.

This new medication is called Vyleesi (bremelanotide). The FDA approved it to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

This medication is specifically intended for HSDD, which is low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

  • A co-existing medical condition
  • A psychiatric condition
  • Problems within a relationship
  • The effects of a medication or other drug substance

Bremelanotide is for acquired HSDD, which means that there were no issues with sexual desire in the past.

The way in which bremelanotide improves sexual desire is unknown, but the FDA noted that the medication works on the melanocortin receptors.

This new medication is available as an injection to be given under the skin of the stomach or thigh at least 45 minutes before sexual activity. Taking more than one dose in 24 hours or more than eight doses in a month is not recommended.

The drug label indicates that the treatment is to be discontinued if there is no improvement in sexual desire after eight weeks of treatment.

Common side effects may include nausea and vomiting, flushing, injection-site reactions and headache.

Nausea is a very common side effect, according to the FDA. In fact, based on clinical trial data, about 40 percent of patients experienced nausea (usually with the first injection). Thirteen percent of women needed medications to treat nausea tied to Vyleesi.

Because this medication increased blood pressure after dosing during clinical trials, those with uncontrolled high blood pressure and those with known heart disease should not use this medication.

The FDA granted Vyleesi’s approval to AMAG Pharmaceuticals.

Ask your health care provider any questions you may have.

Written by Anyssa Garza, PharmD, BCMAS



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