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Positive Phase II Results With Opioid Receptor Modulator in Patients With Major Depression
Positive results have been announced from a phase II study of ALKS 5461 (Alkermes PLC), a new drug compound for patients with major depressive disorder (MDD) who have shown an inadequate response to standard therapies for clinical depression. According to the drug’s developer, ALKS 5461 modulates opioid receptors in the brain and is designed as a nonaddictive, oral, once-daily treatment.
Preliminary data showed that ALKS 5461 significantly reduced depressive symptoms compared with placebo across a range of standard measures, including the study’s primary outcome measure — the Hamilton Depression Rating Scale (HAM-D17) (P = 0.026) — as well as the Montgomery–Åsberg Depression Rating Scale (MADRS) (P = 0.004) and the Clinical Global Impression–Severity Scale (CGI-S) (P = 0.035).
The randomized, double-blind, placebo-controlled study assessed the efficacy and safety of two doses of ALKS 5461 administered once daily as adjunctive treatment in 142 patients with MDD who had shown an inadequate response to a stable dose of either a selective serotonin reuptake inhibitor (SSRI) or a serotonin–norepinephrine reuptake inhibitor (SNRI). The patients received one of two dosing regimens of oral ALKS 5461 or placebo for 4 weeks. The study’s primary endpoint was the change from baseline in depressive symptoms over the 4-week treatment period, as measured by the HAM-D17. Secondary endpoints included additional analyses of patient responses based on HAM-D17, MADRS, and CGI-S scores.
Data from this phase II study will be presented at the 53rd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Fla., May 28–31, 2013. In addition, the drug’s developer, Alkermes PLC, plans to advance ALKS 5461 into a pivotal development program.
ALKS 5461 is a combination of ALKS 33 and buprenorphine and is designed to be a nonaddictive opioid modulator.
According to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), 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 2-week period, and demonstrate impaired social, occupational, educational, or other important functioning. An estimated 16.1 million people in the U.S. have MDD in a given year, and most of these individuals may not respond adequately to initial antidepressant therapy.
Source: Alkermes PLC; April 17, 2013.