AMAG Pharmaceuticals Announces the Publication of the Phase 3 Vyleesi™ (Bremelanotide Injection) Data in Obstetrics & Gynec...
October 11 2019 - 8:00AM
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced that the data
from its two pivotal, double-blind placebo-controlled Phase 3
trials (RECONNECT) and its voluntary open-label one year extension
studies were published in Obstetrics & Gynecology (the
Green Journal). These publications are currently available
online and will appear in the November print issue. In both
randomized placebo-controlled clinical trials, Vyleesi™
(bremelanotide injection) met the pre-specified co-primary efficacy
endpoints of improvement in desire and reduction in associated
distress as measured by validated patient-reported outcome
instruments. These endpoints are the hallmark symptoms of
hypoactive sexual desire disorder (HSDD). The RECONNECT data from
approximately 1,200 women was the basis for the June 2019 U.S. Food
and Drug Administration approval of Vyleesi, the first and only
as-needed treatment for premenopausal women with acquired,
generalized HSDD.
"As a health care provider, I see first-hand how distress from
low sexual desire significantly impacts my patients' lives," said
Anita H. Clayton, M.D., Chair, Department of Psychiatry &
Neurobehavioral Sciences, University of Virginia School of
Medicine, VA. "I'm excited that this publication will raise
awareness of HSDD as well as potential treatment options."
While patients were still blinded to their treatment assignment,
they were asked via a validated, questionnaire
(GAQ-3), "Compared to the start of the study (prior to taking
the study drug or placebo) to what degree do you think you have
benefited from treatment?" Nearly 60 percent of
patients taking Vyleesi reported feeling “better” to “very
much better” compared to 36 percent of patients in the placebo
group. Among those who completed the placebo-controlled,
double blind portion of the study, approximately 80 percent of
those women chose to continue to the voluntary open-label extension
phase where all patients received study drug. Data from this
52-week open-label extension showed sustained efficacy for patients
who had received study drug in the initial study and no new safety
signals were observed. Additionally, patients who began taking
study drug during the extension phase for the first time showed
similar improvements in desire and reductions in associated
distress to those seen during the randomized portion of the study
in patients treated with study drug.
“The RECONNECT data support the consistent efficacy and
long-term safety profile of Vyleesi,” said Julie Krop, M.D., Chief
Medical Officer at AMAG. “AMAG is excited to be able to provide
this important new therapy to patients and is committed to raising
awareness of HSDD and making Vyleesi available to the approximately
6 million premenopausal U.S. women who suffer from this condition.
I would like to thank the many women who made this possible
by participating in our clinical trials.”
In the pivotal trials, the most common adverse events were
nausea, flushing, injection site reactions, headache and vomiting.
The majority of events were reported to be transient and
mild-to-moderate in intensity. In the clinical trials, Vyleesi
caused small, transient increases in blood pressure, and is
contraindicated in women with uncontrolled high blood pressure or
known cardiovascular disease.
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. Women should not inject more than one dose of Vyleesi
within 24 hours of their last dose and should not inject more than
eight doses of Vyleesi within a month. While the exact mechanism of
action is unknown, Vyleesi is believed to bind to, and exert its
effects via, melanocortin receptor agonism in the central nervous
system.
The most common side effects of VYLEESI include nausea,
flushing, injection site reactions and headache. Do not use
VYLEESI if you are pregnant, or have uncontrolled hypertension,
known heart disease or are taking oral naltrexone-containing
products intended to treat opioid or alcohol addiction. Although
less common, Vyleesi may also cause vomiting or darkening of the
skin on certain parts of the body (focal hyperpigmentation)
including the face, gums (gingiva) and breast. Women who can become
pregnant should use effective birth control during treatment with
VYLEESI.
For additional product information, including full prescribing
information, please visit www.vyleesi.com
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, beliefs about the size of the potential population for
Vyleesi; statements about AMAG’s ability to make Vyleesi available
to millions of women suffering with HSDD; statements about the
publication’s ability to raise awareness of HSDD or Vyleesi and the
belief that Vyleesi binds to melanocortin receptors in the central
nervous system and that those receptors are associated with sexual
dysfunction 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 quarters ended March 31, 2019
and June 30, 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.
AMAG Pharmaceuticals Contacts: Investors: Linda
Lennox908-627-3424
Media: Sarah Connors 781-296-0722
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