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–– Once-Daily ALKS 5461 Significantly Improved Depression Scores in Patients With Inadequate Response to Standard Antidepressant Therapies ––
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“We designed ALKS 5461 to have a novel mechanism of action for the
treatment of MDD, a serious disease where new therapeutic options are
highly sought after as millions of patients in the U.S. do not respond
to standard courses of antidepressant therapy,” said
“ALKS 5461 embodies our dedication to developing novel and safe CNS
medicines that address compelling unmet needs faced by large numbers of
patients,” said Richard Pops, Chief Executive Officer of
In the study, ALKS 5461 2mg/2mg met the prespecified primary endpoint of significantly reducing depression scores compared to placebo, as measured by 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) scores (p=0.018). ALKS 5461 2mg/2mg also demonstrated statistically significant reductions in 10-item MADRS (MADRS-10) scores compared to placebo (p=0.026). The 1mg/1mg dose of ALKS 5461 showed improvement in depressive symptoms in the study, but did not separate significantly from placebo.
The most commonly reported adverse events for ALKS 5461 in the FORWARD-5
study were nausea, dizziness and fatigue. These findings are consistent
with those observed in previously reported studies of ALKS 5461.
About the FORWARD-5 Study
FORWARD-5 was a phase 3, randomized, double-blind, multicenter, placebo-controlled, sequential parallel comparison design (SPCD) study that evaluated the safety, tolerability and efficacy of two dose levels of ALKS 5461 (2mg/2mg and 1mg/1mg) as adjunctive treatment in 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). The study randomized 407 subjects.
The study was conducted in two sequential stages: Stage 1 was 5 weeks in duration, Stage 2 was 6 weeks. In Stage 1, the average change from baseline depression scores was calculated for weeks 3 through 5. For Stage 2, the average change was calculated for weeks 3 through 6. The results of Stages 1 and 2 were then averaged. Depression scores were assessed using the 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) and MADRS-10. MADRS-6, a subscale of the MADRS-10 assessment tool for depression, focuses on the core symptoms of depression.
About the 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 additional supportive studies to evaluate the long-term safety, dosing, pharmacokinetic profile and human abuse potential of ALKS 5461. FORWARD-5 is the third phase 3 efficacy study to read out from the FORWARD program. Results from FORWARD-3 and FORWARD-4 were announced in
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 treating MDD. ALKS 5461 consists of samidorphan and buprenorphine, and is designed to rebalance brain function that is dysregulated in the state of depression. In
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
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, development and regulatory plans, and commercial potential 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 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 in Item 1A under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the fiscal year ended
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).
Eva Stroynowski, +1 781-609-6823
Sandy Coombs, +1 781-609-6377
Jennifer Snyder, +1 781-609-6166