Alkermes begins Phase IIIb of ALK 5461 in MDD

Alkermes plc (NASDAQ:ALKS) began the double-blind, placebo-controlled, international Phase IIIb Study 217 to evaluate once-daily oral ALKS 5461 for 11 weeks as adjunctive treatment in about 325 patients with major depressive disorder (MDD).

The trial’s primary endpoint is improvement in MDD symptoms measured by Montgomery-Asberg Depression Rating Scale-6 (MADRS-6) and MADRS-10. Secondary endpoints include Connor-Davidson Resilience Scale (CD-RISC), Snaith-Hamilton Pleasure Scale (SHAPS), quality of life (QOL), Brief Pain Inventory-Short Form (BPI-SF) and Clinical Global Impression of Severity (CGI-S) and Improvement (CGI-I) scales...