BioPlus Specialty Pharmacy (BioPlus), one of the nation’s leading innovative specialty pharmacies, announces that it will be one of only two specialty pharmacies to dispense the newly approved medication Vyleesi™ (bremelanotide injection). Vyleesi, from AMAG Pharmaceuticals, Inc., earned approval from the U.S. Food and Drug Administration (FDA) on June 21, 2019 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Vyleesi is the first as-needed treatment option for this patient population that can be self-administered in anticipation of sexual activity. HSDD is characterized by low sexual desire that causes distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or other drug substance. HSDD affects approximately 1 in 10 premenopausal women. Vyleesi is self-administered with an autoinjector at least 45 minutes before anticipated sexual activity. Patients should not administer more than one dose within 24 hours or 8 doses per month.
“BioPlus is ready to dispense Vyleesi to eligible to patients,” shares David DuRoss, Senior Vice President of Trade for BioPlus. “With our extensive history and expertise with specialty pharmaceuticals, we’re proud that BioPlus was selected as a specialty pharmacy for this new medication. Our pharmacists are available 24/7, putting us in a unique position to guide patients through starting treatment,” he adds.
The FDA approval of this medication was based on two identical pivotal trials of approximately 1,200 women demonstrating that Vyleesi improved desire and reduced distress related to HSDD as measured by validated patient-reported outcome instruments. At the end of the core six-month studies, women were given the option to continue in an open-label extension study for an additional year. Approximately 80% of the women who completed the six-month studies chose to volunteer for the open label extension in which all the women received Vyleesi. In the pivotal trials, the most common adverse events were nausea, flushing, injection site reactions, headache, and vomiting. The majority of these events were reported to be transient and mild-to-moderate in intensity. Vyleesi also caused small, transient increases in blood pressure and decreases in heart rate, as well as darkening of the skin in some women. Women who are pregnant, or have uncontrolled hypertension, known heart disease or are taking oral naltrexone-containing products intended to treat opioid or alcohol addiction should not use this medication. Women who can become pregnant should use effective birth control during treatment with Vyleesi.
About Vyleesi™ (bremelanotide injection)
Vyleesi is approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The prefilled Vyleesi autoinjector is self-administered into a woman’s abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day. Vyleesi is thought to possess a novel mechanism of action. While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system.
For Full Prescribing Information please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9146ae05-918b-483e-b86d-933485ce36eb&audience=consumer