AMAG Pharmaceuticals Presents New Data on Bremelanotide and Hypoactive Sexual Desire Disorder at the ISSWSH/ISSM Joint Meetin...
March 07 2019 - 08:00AM
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that new
and encore data related to bremelanotide and Hypoactive Sexual
Desire Disorder (HSDD) will be presented at the upcoming
International Society for the Study of Women's Sexual Health
(ISSWSH)/ International Society for Sexual Medicine (ISSM) Joint
meeting taking place in Atlanta, Georgia on March 7-10.
"AMAG’s significant presence at this year's ISSWSH/ISSM Joint
Meeting underscores our deep commitment to raising awareness and
understanding of HSDD, which is estimated to affect approximately
one in ten premenopausal women in the United States,” said Julie
Krop, M.D., chief medical officer and executive vice president of
development at AMAG. “Women with this condition have low sexual
desire or libido which often causes them to avoid intimacy, leading
to self-esteem issues and stress in relationships. Despite the high
prevalence of HSDD, there is a lack of awareness of this medical
condition and an urgent need for safe and effective therapies.”
HSDD is characterized by low sexual desire and associated
distress, and is thought to result from an imbalance in certain
chemicals in the brain that affect sexual excitation or inhibition.
In neuroimaging studies, women with HSDD show different brain
responses to erotic stimuli compared to women with no HSDD. HSDD
often negatively impacts women’s emotional health, intimate
relationships, and overall quality of life.
“The ISSWSH/ISSM Joint Meeting attracts sexual health leaders
from around the world so it is a great opportunity to present our
data and engage in a dialogue on our findings,” continued Dr. Krop.
“At this year’s meeting, we'll share data summarizing the current
clinical approach to the diagnosis and treatment of HSDD based on
data we collected from medical chart reviews. We’ll provide
additional data from our phase 3 clinical program for
bremelanotide, an investigational drug which is under review with
the U.S. Food and Drug Administration (FDA) and has a June 23, 2019
PDUFA date. This data includes a poster on patient experiences
with the drug during the phase 3 trials and an original oral
presentation on the consistent efficacy of bremelanotide
independent of baseline testosterone levels.”
The safety and efficacy of bremelanotide has not been
established by FDA.
Research Podium Session
- Bremelanotide for Hypoactive Sexual Desire Disorders in the
RECONNECT Studies: Analysis of Baseline Free Testosterone Level
Quartile Subgroups (#029); Clayton et al.; Sunday, March 10,
8:40-8:50 a.m. EST
Research Poster Sessions
- Women’s Experiences With Bremelanotide Administered, On Demand,
for the Treatment of Hypoactive Sexual Desire Disorder (#080);
Koochaki et al.; Saturday, March 9; 6:00-7:30 p.m. EST
- Describing the Clinical Approach to Diagnosis and Treatment of
Patients With Hypoactive Sexual Desire Disorder (#086); Parish et
al.; Saturday, March 9; 6:00-7:30 p.m. EST
Symposium
- There's Something Missing: Understanding Her Journey with HSDD;
Speakers, Brooke M. Faught, DNP, WHNP-BC, NCMP, IF, Director of the
Women’s Institute for Sexual Health (WISH), Division of
Urology Associates and Risa Kagan, MD, FACOG, CCD, NCMP
Clinical Professor, Department of Obstetrics, Gynecology and
Reproductive Sciences, UCSF, Sutter East Bay Physicians Medical
Group; Saturday, March 9, 2019, 12:30 p.m. - 1:30 p.m.
EST
About Bremelanotide Bremelanotide, an
investigational product candidate, is being developed for the
treatment of hypoactive sexual desire disorder (HSDD) in
pre-menopausal women. Bremelanotide is designed to be used in
anticipation of a sexual encounter, and is thought to possess a
novel mechanism of action that impacts the excitatory neural
pathways in the brain to restore sexual desire.
Bremelanotide has been studied in more than 30 clinical trials
with over 2,500 women. AMAG’s New Drug Application to the FDA was
supported by clinical data from two large double-blind
placebo-controlled Phase 3 studies in which bremelanotide met the
pre-specified co-primary efficacy endpoints of improvement in
desire and decrease in distress associated with low sexual desire
as measured by validated patient-reported outcomes. Women in the
trials had the option, after completion of the trial, to continue
in an open-label safety extension study for an additional 12
months. Nearly 80 percent of patients elected to remain in the
open-label portion of the study, and all of these patients received
bremelanotide.
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. Bremelanotide
has no known alcohol interactions.
Bremelanotide 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
bremelanotide 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 bremelanotide 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 StatementsThis
press release contains forward-looking information about AMAG
Pharmaceuticals, Inc. 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, statements regarding the prevalence
of HSDD in the U.S. and the lack of awareness about the condition
and statements about the potential cause of HSDD and how it impacts
women’s lives, 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, those risks
identified in AMAG’s filings with the U.S. Securities and
Exchange Commission (the “SEC”), including its Annual Report
on Form 10‐K for the year ended December 31, 2018 and
subsequent filings with the SEC, including Current Reports on
Form 8-K, 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® is a registered trademark of AMAG
Pharmaceuticals, Inc.
AMAG Pharmaceuticals Contacts: Investors: Linda
Lennox908-627-3424
Media: Sarah Connors 781-296-0722
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