–– Significantly Improved Depression Scores in 142-Patient
Study Testing Novel Mechanism of Action for
–– Company Plans to Initiate Pivotal Development Program ––
–– Data to be Presented at
“The improvements in depressive symptoms observed in patients treated
with ALKS 5461 in this study were clinically meaningful and among the
most robust I have seen in a phase 2 study for depression in the past
two decades. This promising candidate could provide a valuable new
treatment approach for this serious and chronic disease,” stated
The phase 2, randomized, double-blind, multicenter, placebo-controlled
study assessed the efficacy and safety of two doses of ALKS 5461 when
administered once daily for four weeks as adjunctive treatment in 142
patients with MDD who had an inadequate response to a stable dose of
either a selective serotonin reuptake inhibitor (SSRI) or a
serotonin-norepinephrine reuptake inhibitor (SNRI). Patients received
one of two dosing regimens of oral ALKS 5461 or placebo for a treatment
period of four weeks. The study utilized a sequential parallel
comparison design, a design developed ten years ago by Drs. Fava and
Schoenfeld at
“ALKS 5461 has the potential to be a novel therapy with a unique
mechanism of action for depression and validates our expertise with
opioid modulators,” stated
About ALKS 5461
ALKS 5461 is the combination of ALKS 33 and buprenorphine and is designed to be a non-addictive opioid modulator. ALKS 33 is an oral opioid modulator that builds on Alkermes’ scientific expertise in opioid biology and pharmacology, as well as the company’s clinical and commercial knowledge in the field of addiction and central nervous system disorders.
About MDD
According to the DSM-IV-TR® (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision), 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 of ALKS 5461; the clinical
development of ALKS 5461, including the results of meetings with
regulatory authorities and the product’s clinical development timeline;
and the timing of the company’s planned presentation of phase 2 data of
ALKS 5461. You are cautioned 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 the company will initiate a pivotal development
program for ALKS 5461; whether future clinical trials for ALKS 5461 will
be completed on time or at all; potential changes in cost, scope and
duration of the ALKS 5461 clinical development program; whether ALKS
5461 could be shown ineffective or unsafe during clinical studies, and
whether the company will not be permitted by regulatory authorities to
undertake new or additional clinical studies for ALKS 5461; and those
risks described in the
DSM-IV-TR® 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
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For
Media:
Jennifer Snyder, +1 781-609-6166