Alkermes plc (NASDAQ: ALKS) today announced positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. ALKS 5461 reflects a new approach to the treatment of MDD based on modulation of opioid receptors in the brain and is designed as a non-addictive, oral, once-daily medicine. Data from the study showed that ALKS 5461 significantly reduced depressive symptoms across a range of standard measures including the study's primary outcome measure, the Hamilton Depression Rating Scale (HAM-D17)>rd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Hollywood, Fla., May 28-31, 2013.
“There is significant unmet medical need for novel treatments with new mechanisms of action for depression, as many patients do not adequately respond to existing pharmacological therapies.”
"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 Maurizio Fava, M.D., Director of the Depression Clinical and Research Program at Massachusetts General Hospital and Slater Family Professor of Psychiatry at Harvard Medical School. "There is significant unmet medical need for novel treatments with new mechanisms of action for depression, as many patients do not adequately respond to existing pharmacological therapies."
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 Massachusetts General Hospital and now widely utilized in clinical trials. The primary endpoint of the study was the change from baseline in depressive symptoms over a four-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.
"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 Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "Based on the strength of these data, as well as the positive results seen in the prior clinical study, we will move forward rapidly to meet with the FDA and initiate a pivotal development program with a goal of bringing this important new medication to patients with MDD."