- Program to Begin in Early 2014 –
The company and the
“We prepared a robust and innovative clinical trial plan and are pleased
with the FDA’s positive feedback that enables us to move directly into
the ALKS 5461 phase 3 program in early 2014,” said
About ALKS 5461
ALKS 5461 is a proprietary investigational medicine with a novel
mechanism for the treatment of major depressive disorder (MDD). The
mechanism of action for ALKS 5461 in the treatment of depressive
symptoms is based on modulation of the opioid system in the brain,
employing a balanced combination of agonism and antagonism of opioid
receptors. ALKS 5461 consists of buprenorphine, a partial agonist, and
ALKS 33, a potent mu-opioid antagonist, and is designed to be a
once-daily, non-addictive medicine. Early clinical development of ALKS
5461 was funded through a grant from the
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 timing of the phase 3 development program for
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: phase 3 development of
ALKS 5461 may not be commenced or completed in a timely manner or at
all, due to factors including, but not limited to, protocol design,
regulatory and institutional review board approval, the rate of patient
enrollment and compliance with good clinical practices; adverse
decisions by regulatory authorities may occur; the company may be unable
to manufacture successfully ALKS 5461; 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:
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