–– Safety and Tolerability Profile of ALKS 5461 Confirmed in FORWARD-1 Study, a Supportive Study in the FORWARD Phase 3 Pivotal Program ––
–– Dosing Regimen Confirmed; Efficacy Data Showed Statistically Significant Improvements in Depression Scores Beginning at Week One and Continuing Through Eight-Week Treatment Period ––
Data from the 66-patient study showed that ALKS 5461 was generally well tolerated in both of the two titration schedules evaluated – one-week and two-week dose escalation schedules. The most common adverse events in the study were nausea, constipation and dry mouth. These findings were consistent with the safety and tolerability profile seen in the 142-patient phase 2 study completed in 2013. Additionally, the exploratory efficacy analyses showed that ALKS 5461 significantly reduced depressive symptoms from baseline starting at Week One and continued to the end of the treatment period at Week Eight in patients who received either of the two titration schedules. The observed changes from baseline were clinically meaningful and statistically significant (p<0.001). These data support the one-week titration schedule being utilized in the core phase 3 efficacy studies in the FORWARD program.
“This successful study achieved multiple objectives and provided further
confirmation of the tolerability and antidepressive effects of ALKS 5461
in patients failing to achieve adequate clinical response to standard
therapy,” stated Elliot Ehrich, M.D., Chief Medical Officer of
Data from the randomized, double-blind, parallel-arm study showed that
both titration schedules of ALKS 5461 were generally well tolerated, and
there were no serious adverse events reported in the study. The most
common adverse events in the study were nausea, constipation and dry
mouth.
FORWARD-1 Study Design
The FORWARD-1 study evaluated the safety, tolerability and efficacy of two titration schedules of ALKS 5461 administered once daily as adjunctive treatment in 66 patients with MDD who had an inadequate response to commonly prescribed drugs for depression, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Patients were assigned to either a one-week or two-week titration schedule of oral ALKS 5461, for a total treatment period of eight weeks. The primary objective of the study was to evaluate the safety and tolerability of the two titration schedules for ALKS 5461. Efficacy endpoints, including the change in Montgomery–Åsberg Depression Rating Scale (MADRS) total score from baseline and the Clinical Global Impression–Severity Scale (CGI-S) score at Week Eight, were assessed in exploratory analyses. All participants in the double-blind portion of the study were eligible to continue in an open-label phase and receive ALKS 5461 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of ALKS 5461.
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 is the change from
baseline in Montgomery–Åsberg Depression Rating Scale (MADRS) scores.
Further information about the FORWARD studies can be found at www.clinicaltrials.gov.
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,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, tolerability,
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 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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Rebecca Peterson, +1 781-609-6378
or
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Media:
Jennifer Snyder, +1 781-609-6166