The Food and Drug Administration (FDA) has approved Vyleesi (bremelanotide injection; AMAG) for the treatment of premenopausal women with acquired, generalized, hypoactive sexual desire disorder (HSDD) as 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 with the relationship; or the effects of a medication or drug substance.
The approval of Vyleesi, a melanocortin receptor agonist, was based on data from 2 double blind, placebo controlled, randomized parallel group phase 3 trials (RECONNECT) involving 1247 premenopausal women. In these studies, patients were randomized 1:1 to either Vyleesi 1.75mg subcutaneous (SC) injection or placebo with a 24-week evaluation period. Both trials met the pre-specified endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient reported outcome instruments.
After the trial ended, 80% of patients chose to continue in an open label safety extension study for an additional 52 weeks. The most commonly reported adverse reactions in clinical trials included nausea (40% of patients experienced and 13% required medication to treat), flushing, injection site reactions, headache, and vomiting.
Vyleesi is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease as it may increase blood pressure (BP) and reduce heart rate after each dose. In clinical studies, treatment with Vyleesi induced maximal increases of 6mmHg in systolic BP (SBP) and 3mmHg in diastolic BP (DBP) that peaked between 2-4 hours after dosing; there was a corresponding reduction in heart rate up to 5 beats per minute. BP and heart rate returned to baseline usually within 12 hours post-dose.
Vyleesi is administered by subcutaneous injection by the patient via a prefilled single-dose autoinjector pen (1.75mg/0.3mL) at least 45 minutes prior to anticipated sexual activity; the duration of efficacy after each dose is unknown and only 1 dose should be administered in a 24 hour period to minimize the risk of pronounced BP effects. Treatment should be discontinued if no improvement in sexual desire and associated distress is noted after 8 weeks.
Vyleesi is expected to be available in September 2019 through select specialty pharmacies.
For more information visit vyleesi.com.