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Alkermes plc Presents Positive Clinical Data of ALKS 5461


Tuesday, 29 May 2012 04:00pm EDT 

Alkermes plc announced positive results from the phase 1/2 study of ALKS 5461, a drug compound for depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, in an oral session at the 52 Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Phoenix. In the phase 1/2 clinical study, ALKS 5461 was shown to significantly reduce depressive symptoms, as measured by the Hamilton Depression Rating Scale (HAM-D17; a standard, clinician-assessed measure of depression severity), in patients with MDD who received ALKS 5461 for the seven-day treatment period. In addition, data from the study showed that ALKS 5461 was generally well tolerated. ALKS 5461 is the combination of buprenorphine and ALKS 33, a opioid modulator. Based on the positive results of the phase 1/2 study, a phase two study of ALKS 5461 was initiated in January 2012 to further evaluate the utility of ALKS 5461 in treating MDD. The phase 2 trial is a randomized, double-blind, multicenter, placebo-controlled study that will evaluate the efficacy and safety of ALKS 5461 when administered once daily for four weeks in approximately 130 patients with MDD who have inadequate response to antidepressant therapy. Data from the study are expected in the first half of calendar 2013.