7:00AM Alkermes presents positive results from phase 2 clinical study of ALKS 5461 in major depressive disorder at 53rd Annual NCDEU Meeting; ALKS 5461 met its primary endpoint (ALKS) 33.58 : Co announced the presentation of positive phase 2 data for ALKS 5461, a novel opioid modulator, in patients with major depressive disorder and inadequate response to standard therapies. In the phase 2 study, ALKS 5461 met its primary endpoint, met key secondary endpoints and demonstrated significant reduction in depressive symptoms versus placebo. The study is being presented in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit Meeting in Hollywood, Fla., by Maurizio Fava, M.D., of Massachusetts General Hospital and Harvard Medical School.
The phase 2 study of ALKS 5461 utilized a sequential parallel comparison design, designed to reduce the impact of clinically meaningful response to treatment with placebo. The study included two four-week, randomized, double-blind stages run in sequence: an Initial Study Stage and a Successive Study Stage. The Successive Study Stage randomized only those patients who were non-responders to placebo in the Initial Study Stage. Both stages of the phase 2 study evaluated two doses of ALKS 5461, a lower dose and a higher dose.
In the phase 2 results for the overall study population, including both the Initial Study Stage and the Successive Study Stage, patients who received either dose of ALKS 5461 for a treatment period of four weeks showed a significant reduction in depressive symptoms from baseline in HAM-D17 and MADRS scores, compared to placebo. The primary endpoint of the phase 2 study was the change from baseline in depressive symptoms over a four-week treatment period in the overall study population, as measured by HAM-D17, compared to placebo. Data from the study showed that ALKS 5461 was generally well tolerated. The most common adverse events observed in the study were nausea, headache and dizziness.
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