The First FDA-Approved As-Needed Treatment for Premenopausal Women Experiencing Distress or Interpersonal Difficulty Due to Low Sexual Desire
1 in 10 Premenopausal Women in the U.S. (Approximately 6 Million Women) Suffer From HSDD
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 within the relationship, or the effects of a medication or other drug substance.
“HSDD has been recognized as a medical condition since the 1970s, yet it has been widely underdiagnosed and undertreated,” said
HSDD is thought to have a neurobiologic basis which is supported by brain imaging studies. When study participants were shown visual sexual stimuli, there was a difference in the brain activation patterns between women with HSDD compared to those women without HSDDi.
“Today's approval underscores AMAG’s commitment to women’s health and dedication to raising awareness and improving education about HSDD,” said
In the pivotal trials, the most common adverse events were 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.
AMAG is committed to working with payers and healthcare professionals to help ensure women with HSDD have access to Vyleesi. The product will be commercially available in September through select specialty pharmacies. To raise healthcare provider awareness of Vyleesi, AMAG will leverage its existing women’s and maternal health sales force of approximately 125 sales representatives calling on U.S. obstetrics, gynecologists and sexual medicine specialists, and will also offer patients the ability to connect with a physician through a telemedicine option. Patients and providers can learn more about HSDD and Vyleesi at www.vyleesi.com and sign up to receive information about how to obtain Vyleesi as soon as it is available.
AMAG in-licensed Vyleesi from
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 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. While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system. Vyleesi has no known alcohol restrictions.
Vyleesi (bremelanotide injection) Important Safety Information
VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease.
Warnings and Precautions
Transient Increase in Blood Pressure and Decrease in Heart Rate: VYLEESI transiently increases blood pressure and reduces heart rate after each dose. Advise patients that these changes usually resolve within 12 hours. VYLEESI is not recommended in patients at high risk for cardiovascular disease. Consider the patient’s cardiovascular risk before initiating VYLEESI and periodically during treatment and 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.
Focal Hyperpigmentation: Reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva and breasts. Patients are at higher risk of developing focal hyperpigmentation if they have 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: 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.
Most common adverse reactions (incidence >4%) are nausea, flushing, injection site reactions, headache, and vomiting.
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.
Advise patients to 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.
For full Prescribing Information, please see package insert.
VYLEESI is indicated 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.
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
Limitations of Use
- VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men.
- VYLEESI is not indicated to enhance sexual performance.
Vyleesi is protected by a number of U.S. and foreign patents and applications that are owned by
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. For additional company information, please visit www.amagpharma.com.
Forward-Looking Statements This press release contains forward-looking information about AMAG within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, the belief that HSDD is underdiagnosed and undertreated; beliefs about the size of the potential population for Vyleesi and the behaviors of such potential patients; beliefs about low sexual desire in women, including the causes; the belief that HSDD is the most common female sexual dysfunction condition; the anticipated access to Vyleesi; the timing for commercial availability and plans to leverage AMAG’s sales force and provide patient access to physicians are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, the ability of AMAG to successfully execute on its commercialization plans and the level of market adoption for Vyleesi; the likelihood that healthcare providers, patients and/or healthcare payers will support the commercialization and use of Vyleesi; the risk that AMAG has over-estimated the size of the market for Vyleesi; as well as those risks identified in AMAG’s filings with the
AMAG Pharmaceuticals® and the logo are registered trademarks of AMAG Pharmaceuticals, Inc. Vyleesi™ is a trademark of AMAG Pharmaceuticals, Inc. and Makena® is a registered trademark of AMAG Pharma USA, Inc.
AMAG Pharmaceuticals Contacts:
i Arnow B, et al. (2009) “Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study” Neuroscience; 158(2):484-502; Bianchi-Demicheli, Francesco et al. (2011) “Neural Bases of Hypoactive Sexual Desire Disorder in Women: An Event-Related fMRI Study”
Source: AMAG Pharmaceuticals, Inc.