–– FORWARD Phase 3 Studies Designed to Provide Basis for New Drug Application ––
The FORWARD pivotal program will evaluate the safety and efficacy of
ALKS 5461 in patients suffering from MDD who have had an inadequate
response to commonly prescribed drugs, including selective serotonin
reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake
inhibitors (SNRIs).
“With a novel mechanism of action and Fast Track designation from the
About the Phase 3 FORWARD Clinical Program
The FORWARD (Focused On Results With A Rethinking of Depression) pivotal program for ALKS 5461 will include 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 will 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 the Phase 2 Study Results for ALKS 5461
In
About ALKS 5461
ALKS 5461 is a proprietary investigational oral medicine for the
treatment of MDD. ALKS 5461 has a novel mechanism of action in the
treatment of depressive symptoms based on modulation of the opioid
system in the brain, employing a balanced combination of agonist and
antagonist components that act on opioid receptors, and includes a novel
opioid modulator, samidorphan, discovered by
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,1,2 the majority of whom may not adequately respond to initial antidepressant therapy.3
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, 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: clinical trials of the company’s
products may be unsuccessful or not initiated or conducted in a timely
manner; its products may not show sufficient therapeutic effects or
acceptable safety profiles; adverse decisions by regulatory authorities;
existing clinical and preclinical data with respect to its products may
not be indicative of future clinical or commercial results; the
company’s inability to manufacture successfully its products; and those
risks described in the
DSM-5® is a registered trademark of the
1 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.
2 U.S. Census.
3 Rush AJ et al (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).
Source:
Alkermes
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