AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that the
U.S. Food and Drug Administration (FDA) has approved Vyleesi™
(bremelanotide injection), a melanocortin receptor agonist, to
treat acquired, generalized hypoactive sexual desire disorder
(HSDD) in premenopausal women. The Vyleesi autoinjector is the
first treatment for this patient population that can be
self-administered as needed 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 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 Anita H. Clayton, M.D., Chair, Department of Psychiatry &
Neurobehavioral Sciences, University of Virginia School of
Medicine, VA. “Women with HSDD often avoid situations that could
lead to intimacy, the impact of which goes far beyond the bedroom
and can often result in anxiety, loss of vitality, self-esteem
issues and relationship stress. It is important that women
suffering with this condition have a choice of treatment options
available to them.”
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 Julie Krop, M.D., chief medical officer at AMAG.
“While HSDD is the most common female sexual dysfunction condition,
it is largely under-recognized. I want to thank the thousands of
women who participated in the clinical trials to support the
approval of Vyleesi. Their participation in the trials helped to
pave the way for a novel treatment option that offers hope to the
nearly six million premenopausal women who have suffered in silence
from HSDD—empowering them to reclaim their sexual desire.”
The FDA approval of Vyleesi is based upon data from
approximately 1,200 women in two pivotal, double-blind placebo
controlled Phase 3 trials (RECONNECT). In both clinical trials,
Vyleesi met the pre-specified co-primary efficacy endpoints of
improvement in desire and reductions in distress as measured by
validated patient-reported outcome instruments. 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 percent of patients who completed the Phase 3 trials
elected to remain in the open-label portion of the study, where all
of these patients received Vyleesi.
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 Palatin Technologies, Inc. in
February 2017. Under the terms of the agreement, the approval of
Vyleesi by the FDA triggers a $60 million payment obligation to
Palatin. In addition, 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 sales milestones
based on escalating annual net sales thresholds, the first of which
is $25 million, triggered at annual net sales of $250
million.
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
ContraindicationsVYLEESI is contraindicated in
patients who have uncontrolled hypertension or known cardiovascular
disease.
Warnings and PrecautionsTransient
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.
Adverse ReactionsMost common adverse reactions
(incidence >4%) are nausea, flushing, injection site reactions,
headache, and vomiting.
Drug InteractionsVYLEESI 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.
PregnancyAdvise 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.
IndicationVYLEESI 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 Palatin Technologies, Inc. Certain
of the patents include claims directed to the Vyleesi drug
composition and methods of use thereof with terms expiring in 2020,
and other patents include claims directed to methods of treating
female sexual dysfunction by subcutaneous administration of
compositions that include Vyleesi with terms expiring in 2033.
About AMAGAMAG 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 U.S.
Securities and Exchange Commission (SEC), including its Annual
Report on Form 10-K for the year ended December 31, 2018, its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019
and subsequent filings with the U.S. Securities and Exchange
Commission (the “SEC”), which are available at the SEC’s website at
www.sec.gov. Any such risks and uncertainties could materially and
adversely affect AMAG’s results of operations, its profitability
and its cash flows, which would, in turn, have a significant and
adverse impact on AMAG’s stock price. AMAG cautions you not to
place undue reliance on any forward-looking statements, which speak
only as of the date they are made. AMAG disclaims any
obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements.
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: Investors: Linda
Lennox908-627-3424
Media: Sarah Connors 781-296-0722
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