NORTH CHICAGO, Ill.,
Oct. 6, 2016 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global biopharmaceutical company, in cooperation
with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced
that new data from two replicate Phase 3 studies evaluating the
efficacy and safety of Elagolix, an investigational, orally
administered gonadotropin-releasing hormone (GnRH) antagonist, in
premenopausal women with endometriosis, will be presented at the
upcoming 72nd American Society for Reproductive Medicine
Scientific Congress & Expo (ASRM), October 15-19, in Salt
Lake City. Additional data highlighting the economic and
healthcare burden associated with endometriosis will also be
presented.
"Endometriosis affects an estimated one in 10 women,1
and physicians and their patients are seeking alternative options
to help relieve symptoms of this disease," said Rob Scott, M.D., Vice President, Development and
Chief Medical Officer, AbbVie. "The data highlight the efficacy and
safety profile of Elagolix in the treatment of pain associated with
endometriosis, and underscore AbbVie's efforts to help address the
needs of women suffering from endometriosis."
AbbVie Posters:
- Elagolix, An Oral Gonadotropin-Releasing Hormone (GnRH)
Antagonist, For The Management Of Endometriosis-Associated Pain:
Safety And Efficacy Results From Two Double-Blind, Randomized,
Placebo-Controlled Studies; Taylor H, et al.; Abstract
#P440; Poster Session; Wednesday, October, 19, 2016; 7:00AM – 8:45AM
MDT
- Use Of Elagolix For The Management Of
Endometriosis-Associated Pain: Secondary Efficacy Results From Two
Randomized, Placebo-Controlled Studies : Surrey, et al.;
Abstract #P434; Poster Session; Wednesday, October, 19, 2016;
7:00AM – 8:45AM MDT
- The Effect Of Elagolix On Bone Mineral Density: Safety
Results From Two Randomized, Placebo-Controlled Studies In Women
With Endometriosis-Associated Pain; Archer et al.;
Abstract #P455; Poster Session; Wednesday, October, 19, 2016;
7:00AM – 8:45AM MDT
- Incremental Costs of Healthcare and Work Loss Attributed to
Endometriosis in a Cohort of Commercially Insured Women;
Soliman et al.; Abstract #P432; Poster Session; Wednesday,
October, 19, 2016; 7:00AM –
8:45AM MDT
- Incidence of Comorbidities Among Women with Endometriosis: A
Retrospective Matched Cohort Study; Soliman et al.;
Abstract # P457; Poster Session; Wednesday, October, 19, 2016;
7:00AM – 8:45AM MDT
AbbVie Oral Presentations
- The Effect Of Elagolix On The Endometrium: Safety Results
From Two Randomized, Placebo-Controlled Studies In Women With
Endometriosis-Associated Pain; Diamond et al.; Abstract
#O232; Oral Session; Wednesday, October, 19, 2016; 11:15AM – 12:45PM
MDT
- The Impact of Elagolix on Quality of Life in Women with
Endometriosis-Associated Pain: Results From Two Randomized,
Placebo-Controlled Studies Using the Endometriosis Health Profile
Questionnaire; Taylor H et al.; Abstract #O229; Oral
Session; Wednesday, October, 19, 2016; 11:15AM – 12:45PM
MDT
- Direct and Indirect Costs Associated with
Endometriosis-Related Surgery Among Employed Women in the US;
Soliman et al.; Abstract #O230; Oral Session; Wednesday,
October, 19, 2016; 11:15AM –
12:45PM MDT
About Endometriosis
Endometriosis occurs when the
cells that normally line the uterus begin to grow outside of the
uterus, leading to chronic pelvic pain, pain with intercourse and
heightened pain with menses.2 These growths are called
lesions and can occur on the ovaries, the fallopian tubes, or other
areas near the uterus, such as the bowel or bladder.3,4
There is no cure for endometriosis and the associated pain is
currently managed with oral contraceptives, progestins, danazol,
nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH
agonists, many of which are not specifically indicated for the
treatment of endometriosis. In more extensive cases, surgical
interventions (e.g., laparotomy or laparoscopy) are often pursued,
and may not be curative for all individuals.5
About Elagolix
Elagolix, a gonadotropin-releasing
hormone (GnRH) antagonist, is an orally administered, short-acting
molecule that blocks GnRH signaling by binding to GnRH receptors in
the pituitary gland. Administration results in rapid, reversible,
dose-dependent inhibition of luteinizing hormone (LH) and
follicle-stimulating hormone (FSH) secretion, leading to reduced
ovarian production of the sex hormones, estradiol and progesterone.
Elagolix is currently being investigated in diseases that are
mediated by sex hormones, such as uterine fibroids and
endometriosis. To date, Elagolix has been studied in over 40
clinical trials totaling more than 3,000 subjects. Phase 3 trials
of Elagolix for the management of uterine fibroids are ongoing.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott Laboratories. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most
complex and serious diseases. Together with its wholly-owned
subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people
worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com. Follow @abbvie on Twitter
or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this
news release may be forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995. The words
"believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2015 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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1 World
Endometriosis Society: Facts About Endometriosis:
http://endometriosisfoundation.org/Facts-about-endometriosis.pdf.
Accessed October 10, 2016.
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2 Mayo
Clinic. Diseases and Symptoms: Endometriosis Fact Sheet.
http://www.mayoclinic.org/diseases-conditions/endometriosis/basics/symptoms/con-20013968.
Accessed February 1, 2016.
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3 MM,
Silverberg K, Olive DL. Endometriosis and Adenomyosis. IN: Copeland
LJ, Jarrell JF, eds. Textbook of Gynecology. 2nd ed. Philadelphia,
PA: WB Saunders; 2000:687-722.
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4 The
American College of Obstetricians and Gynecologists. ACOG Education
Pamphlet AP013: Endometriosis. Washington, DC: September 2008. ISSN
1074-8601.
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5 Mayo
Clinic. Diseases & Conditions: Endometriosis Fact Sheet.
http://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/treatment/txc-20236449.
Accessed February 1, 2016.
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SOURCE AbbVie