AMAG Pharmaceuticals’ Vyleesi™ was Approved
The U.S. Food and Drug Administration (FDA) approved AMAG Pharmaceuticals’ (AMAG) product Vyleesi (bremelanotide injection); a melanocortin receptor agonist for premenopausal women having acquired, generalized hypoactive sexual desire disorder (HSDD)
To be a candidate for Vyleesi a woman’s low sexual desire must not be the outcome of a co-existing medical or psychiatric condition, problems within the relationship or the side effect of medications. The condition Vyleesi is approved to treat is of neurobiological origin supported by brain imaging studies.
When study participants were shown visual sexual stimuli there was a difference in brain activation patterns between women with HSDD compared to women without HSDD.
The FDA approval of Vyleesi is based upon clinical trial data demonstrating that the product met the pre-specified co-primary efficacy endpoints of improvement in desire and reductions in distress. It is to be noted that upon completion of the trial women had the option to continue, in a voluntary open-label safety extension study, for an additional 12 months. Nearly 80% of patients who completed the Phase 3 trials elected to remain in the open-label portion of the study where they all received Vyleesi.
The Most Common Adverse Events of Vyleesi™
Nausea, flushing, injection site reactions, and headache. The majority of events were reported to be transient and mild-to-moderate in intensity. In clinical trials Vyleesi caused small, transient increases in blood pressure and is contraindicated in women with uncontrolled high blood pressure or known cardiovascular risk.
While the exact mechanism of action of Vyleesi is unknown the product is believed to bind to melanocortin receptors in the central nervous system. Vyleesi has no known alcohol restrictions. The prefilled Vyleesi autoinjector pen 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.
Vyleesi™ Contraindications, Warnings and Precautions:
- Vyleesi transiently increases blood pressure and reduces heart rate after each dose. Patients should be advised that these changes usually resolve within 12 hours.
- Vyleesi is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease and not recommended in patients suffering either.
- Consider the patient’s cardiovascular risk before initiating Vyleesi and, periodically during treatment, ensure blood pressure is well-controlled.
- To minimize the risk of more pronounced blood pressure effects patients should not take more than one Vyleesi dose within 24 hours.
- Patients should not use more than 8 Vyleesi doses per month.
Other Adverse Effects of Vyleesi™
Focal Hyperpigmentation was reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva, and breasts. At higher risk of developing focal hyperpigmentation are those with darker skin and with daily dosing. Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of Vyleesi. Consider discontinuing Vyleesi if hyperpigmentation develops.
Nausea was reported by 40% of patients who received up to 8 monthly doses requiring anti-emetic therapy in 13% of patients and leading to premature discontinuation for 8% of patients. Nausea improves for most patients with the second dose. Consider discontinuing Vyleesi or initiating anti-emetic therapy for persistent or severe nausea.
Vyleesi™ Drug Interactions
Vyleesi may slow gastric emptying and impact absorption of concomitantly administered oral medications. Vyleesi may significantly decrease the systemic exposure of orally-administered naltrexone. Avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction.
Discontinue Vyleesi if pregnancy is suspected. Advise patients to use effective contraception while taking Vyleesi. There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vyleesi during pregnancy. Pregnant women exposed to Vyleesi, and healthcare providers, are encouraged to call the Vyleesi Pregnancy Exposure Registry at 1-877-411-2510.
We believe that the time has come for the premenopausal women with the HSDD condition to be treated. So the FDA approval of Vyleesi is offering a new specific treatment option for these women who did not have any.
AMAG had in-licensed Vyleesi from the small firm Palatin Technologies (PTN). In addition to a $60 million payment obligation to Palatin following the product approval, AMAG will pay Palatin tiered royalties on annual net sales of Vyleesi ranging from the high-single digits to the low double-digits. AMAG will also pay Palatin on escalating annual net sales thresholds, the first of which is $25 million, triggered at annual net sales of $250 million.
Palatin Stock was trading this morning at $1.48 UP $0.14. The firm’s market CAP is $300.53 million.
AMAG Pharmaceuticals stock was trading this morning at $9.29 UP $0.28. The firms market CAP was $312.68.
It is difficult to speculate on the sales revenues; we have to first learn about the number of premenopausal women who live with the HSDD condition, the percentage of women who have the condition but cannot take the product because of other conditions and those who would refuse to take the product because of adverse effects or other reasons.
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