NORTH CHICAGO, Ill.,
Jan. 28, 2016 /PRNewswire/
-- AbbVie (NYSE: ABBV), in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), today announced the initiation of
the first of two planned Phase 3 clinical studies evaluating the
safety and efficacy of Elagolix alone or in combination with
add-back therapy compared to placebo. These studies are designed to
assess the change in menstrual blood loss utilizing the alkaline
hematin method, comparing baseline to month six of treatment.
Additional secondary efficacy endpoints are being evaluated;
including assessing changes in fibroid volume, monthly blood loss
and hemoglobin levels. Bone mineral density will also be
assessed.
"There are limited, non-surgical treatment options for women
suffering from heavy menstrual bleeding associated with uterine
fibroids. AbbVie is eager to further explore Elagolix's potential
to address this unmet need," said Michael
Severino, M.D., executive vice president, research and
development and chief scientific officer, AbbVie.
The Elagolix Phase 3 uterine fibroid clinical development
program is part of AbbVie's pipeline and includes two replicate,
randomized, parallel, double-blind, placebo-controlled clinical
trials. Each trial is expected to enroll approximately 400 subjects
for an initial six-month placebo-controlled dosing period, after
which, subjects who are eligible will have an option to continue
for an additional six-month dosing period in a safety and efficacy
extension study. AbbVie will make a $15MM milestone payment to
Neurocrine Biosciences upon enrollment of the first patient.
Uterine fibroids (also called leiomyomas or myomas) are
noncancerous muscle tissue tumors of the uterus.1
Fibroids are most common in women aged 30-40 years but can occur at
any age.1 They can range in size from nearly
undetectable to bulky masses that can distort the
uterus.2 Fibroids can be asymptomatic but in some women
cause symptoms such as: longer, more frequent, or heavy menstrual
bleeding; menstrual pain; vaginal bleeding at time other than
menstruation; pain in the abdomen or lower back; pain during sex;
difficulty urinating; frequent urination; constipation or rectal
pain.1
About Elagolix
Elagolix is an orally administered
gonadotropin-releasing hormone (GnRH) antagonist that 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
endometriosis-associated pain are also 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 2014 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.
1American Congress of Obstetricians and Gynecologist.
Frequently Asked Questions about Gynecologic Problems Uterine
Fibroid Fact Sheet.
http://www.acog.org/Patients/FAQs/Uterine-Fibroids. Accessed
January 25, 2016.
2 Mayo Clinic. Diseases and Conditions: Uterine
Fibroids.
http://www.mayoclinic.org/diseases-conditions/uterine-fibroids/basics/symptoms/con-20037901.
Accessed January 25, 2016.
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SOURCE AbbVie