NORTH CHICAGO, Ill.,
Jan. 8, 2015 /PRNewswire/
-- AbbVie (NYSE: ABBV), in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), announced positive top-line
results from the first of two ongoing Phase 3 clinical trials,
designed to evaluate the efficacy and safety of elagolix in
premenopausal women with endometriosis. Results from the trial show
that after six months of treatment, both doses of elagolix (150 mg
once daily and 200 mg twice daily) met the study's co-primary
endpoints (p<0.001) of reducing scores of non-menstrual pelvic
pain (NMPP) and menstrual pain (or dysmenorrhea), associated with
endometriosis, at month three, as well as month six, as measured by
the Daily Assessment of Endometriosis Pain scale.
Endometriosis is associated with a multitude of symptoms, some
of the most common of which include pain related to menstruation as
well as chronic pelvic pain throughout the menstrual cycle, and is
a leading cause of infertility. The World Endometriosis Research
Foundation estimates that endometriosis affects one in ten women
during their reproductive years, representing approximately 176
million women worldwide.
"Endometriosis is a condition in which the tissue that normally
lines the inside of a woman's uterus grows outside the uterus, and
is often associated with severe, and at times, debilitating pain,"
said Michael Severino, M.D.,
Executive Vice President, Research and Development and Chief
Scientific Officer, AbbVie. "The positive results from this trial
represent a significant milestone in the development of elagolix as
a potential new treatment option for patients suffering from
endometriosis."
The observed safety profile of elagolix in this Phase 3 trial
was consistent with observations from prior studies. Among the most
common adverse events (AEs) were hot flush, headache, nausea and
fatigue. While most AEs were similar across treatment groups,
some, such as hot flush and bone mineral density (BMD) loss were
dose-dependent. Overall discontinuation rates were similar across
treatment groups and discontinuations specifically due to AEs were
5.9 percent, 6.4 percent, and 9.7 percent for placebo, 150 mg once
daily and 200 mg twice daily, respectively.
The top-line results are from a six-month, group-level analysis.
Patients in the trial will continue on in either post-treatment
follow-up or a blinded six-month extension study. AbbVie intends to
present detailed results from this trial at a future medical
conference.
Trial Design
The Phase 3 trial (M12-665) is a 24-week,
randomized, double-blind, placebo-controlled study designed to
evaluate the safety and efficacy of elagolix in 872 women, age 18
to 49, with moderate-to-severe endometriosis-associated pain. It is
being conducted at approximately 160 sites in the United States, Puerto Rico and Canada.
A second Phase 3, randomized, multinational, double-blind,
placebo-controlled trial (M12-671) evaluating elagolix in patients
with moderate-to-severe endometriosis-related pain is ongoing and
results are expected in late 2015.
About Elagolix
Elagolix, currently being investigated
in patients with pain from endometriosis, inhibits gonadatropin
releasing hormone (GnRH) receptors in the pituitary gland and
ultimately reduces circulating sex hormone levels. To date,
elagolix has been studied in over 40 clinical trials totaling more
than 3,000 patients. A Phase 2b trial of elagolix for the treatment
of uterine fibroids is also ongoing.
Elagolix is the proposed International Nonproprietary Name
(INN).
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. AbbVie employs
approximately 25,000 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 2013 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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SOURCE AbbVie