Alkermes Presents Positive Clinical Data of ALKS 5461 at 52nd Annual New Clinical Drug Evaluation Unit Meeting

Alkermes plc

today presented positive results from the phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, in an oral session at the 52nd 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 proprietary opioid modulator.