— Phase 3b Study Designed to Further Evaluate ALKS 5461’s Potential Benefits on Mood Domains Regulated by Endogenous Opioid Modulation —
— Company Reiterates Plans to Submit New Drug Application to
“Opioid modulation represents a new mechanism for the treatment of
depression that may provide benefits beyond those observed with
traditional antidepressants. Along with the clinical community, we are
looking forward to further exploring ALKS 5461’s potential in regulating
domains such as social connection, resilience and anhedonia. Study 217
includes scales and endpoints to help elucidate ALKS 5461’s potential
effects on these specific mood domains where opioid modulation may yield
singular benefit,” stated Elliot Ehrich, M.D., Executive Vice President,
Research and Development of
Study 217 is a phase 3b, multinational, randomized, double-blind, placebo-controlled clinical trial that will evaluate the efficacy, safety and tolerability of ALKS 5461 as adjunctive treatment in patients with MDD. The 11-week, 2-stage study will randomize up to 325 patients and incorporates design features informed by the FORWARD pivotal program to help ensure rigorous patient selection, monitoring and evaluation. The primary objective of the study is to assess ALKS 5461’s ability to improve depressive symptoms, as measured by MADRS-6 and MADRS-10. Specific scales to evaluate additional potential benefits of ALKS 5461 included in study 217 are the Connor-Davidson Resilience Scale (CD-RISC), Snaith-Hamilton Pleasure Scale (SHAPS), Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Brief Pain Inventory-Short Form (BPI-SF), and the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.
About ALKS 5461
ALKS 5461 is a
proprietary, investigational, once-daily oral medicine that acts as a
balanced neuromodulator in the brain and represents a novel mechanism of
action for the adjunctive treatment of MDD. ALKS 5461 consists of
samidorphan and buprenorphine, and is designed to rebalance brain
function that is dysregulated in the state of depression. 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 17 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, as amended, including, but not limited to,
statements concerning: the therapeutic value and commercial potential of
ALKS 5461, and the development and regulatory plans and timelines,
including the timing of submission of the NDA, for 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 expressed or implied 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 and commercial potential of 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; whether the preclinical and clinical
results of ALKS 5461 will meet the regulatory requirements for approval;
whether regulatory submissions may occur or be submitted in a timely
manner; and those risks and uncertainties described under the heading
“Risk Factors” in the company’s Annual Report on Form 10-K for the year
ended
DSM-5® is a registered trademark of the American Psychiatric Association.
1 Kessler RC et al (2005) Archives of General
Psychiatry, Jun; 62 (6), pp. 617-27.
2 U.S. Census.
3 Rush
AJ et al (2007) Am J. Psychiatry, 163:11, pp. 1905-1917
(STAR*D Study).
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Source:
Alkermes plc
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Eva Stroynowski, +1 781-609-6823
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