"At ACOG this year we will share new subgroup analyses from our pivotal bremelanotide trials as well as data looking at ferumoxytol in women with AUB," said
BremelanotideResearch Podium Session
“Bremelanotide for Hypoactive Sexual Desire Disorder: Contraceptive Subgroups Efficacy Analysis,”
Bremelanotide Research Poster Session “Efficacy of Bremelanotide Across Hypoactive Sexual Desire Disorder Duration Subgroups,” Sheryl A Kingsberg, PhD,
Bremelanotide is an investigational drug in development for the treatment of HSDD in pre-menopausal women. HSDD is a condition characterized by low sexual desire that causes marked distress or interpersonal difficulty. Approximately 1 in 10 pre-menopausal women in
Feraheme Research Poster Session
“Sustained Improvements in Anemia and Fatigue of AUB after a Single Course of Ferumoxytol: 6-month Follow-up,”
In February of 2018, the
About bremelanotide injection
Bremelanotide, an investigational product candidate, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The PDUFA date for bremelanotide is
Bremelanotide has been studied in more than 30 clinical trials with over 2,500 women. AMAG’s New Drug Application (NDA) to the
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 is protected by a number of U.S. and foreign patents and applications that are owned by
About Feraheme® (ferumoxytol injection)
Feraheme received marketing approval from the
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products.
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product. Feraheme may cause clinically significant hypotension. Excessive therapy with parenteral iron can lead to excess storage of iron and possible hemosiderosis. Administration of Feraheme may transiently affect the diagnostic ability of magnetic resonance imaging. The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.
Feraheme is protected in the U.S. by seven issued patents covering the composition and dosage form of the product, the last of which expires in
For additional product information, including full prescribing information and the boxed warning, please visit www.feraheme.com.
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.
This press release contains forward-looking information about
Such risks and uncertainties include, among others, the risk that bremelanotide will not be approved on a timely basis, or at all and 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® and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa is a registered trademark of
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Source: AMAG Pharmaceuticals, Inc.