– All Three Core Efficacy Studies in FORWARD Pivotal Program Now Underway –
“Our FORWARD pivotal program has strong momentum with all three of our
planned core efficacy studies underway, and each incorporates
state-of-the-art study design elements to reduce the impact of placebo
response commonly observed in depression trials,” stated Elliot Ehrich,
M.D., Chief Medical Officer of
FORWARD-5 is a phase 3, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of ALKS 5461 as adjunctive treatment in approximately 500 patients with MDD. This study, along with the two other core efficacy studies already underway, FORWARD-3 and FORWARD-4, incorporates sophisticated design features to ensure rigorous patient selection, monitoring and evaluation. Data from these three core efficacy studies are expected in 2016.
Further information about the initiated FORWARD studies can be found at www.clinicaltrials.gov.
About the Phase 3 FORWARD Clinical Program
The FORWARD (Focused On
Results With
A Rethinking
of Depression) pivotal program for
ALKS 5461 includes three core phase 3 efficacy studies, as well as nine
supportive studies to evaluate the long-term safety, dosing,
pharmacokinetic profile and human abuse liability of ALKS 5461. The
three core efficacy studies utilize state-of-the-art methodologies to
reduce the impact of clinically meaningful placebo response and are
expected to randomize a total of approximately 1,500 patients with MDD
who have had an inadequate response to standard therapies. The primary
efficacy endpoint for the three core efficacy studies will be the change
from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS)
scores.
About ALKS 5461
ALKS 5461 is a proprietary, oral investigational medicine for the
treatment of major depressive disorder (MDD). ALKS 5461 acts as a
balanced neuromodulator in the brain and represents a new approach with
a novel mechanism of action for treating MDD. In
About MDD
According to the DSM-5® (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 16.1 million people in the U.S. suffer from MDD in a given year,2,3 the majority of whom may not adequately respond to initial antidepressant therapy.1
About
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including, but not
limited to, statements concerning: the therapeutic value, development
plans and commercial potential of ALKS 5461. The company cautions that
forward-looking statements are inherently uncertain. Although the
company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and they are necessarily subject to a high degree of
uncertainty and risk. Actual performance and results may differ
materially from those projected or suggested in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others: whether preclinical and clinical
results for ALKS 5461 will be predictive of future clinical study
results; whether future clinical trials for ALKS 5461 will be completed
on time or at all; potential changes in cost, scope and duration of the
FORWARD pivotal program for ALKS 5461; whether ALKS 5461 could be shown
ineffective or unsafe during clinical studies; and those risks described
in the
DSM-5® is a registered trademark of the
1 Rush AJ et al (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).
2 U.S. Census.
3 Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun; 62 (6): 617-27.
Source:
Alkermes plc
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For
Media:
Jennifer Snyder, +1 781-609-6166