Bettering the odds

A changed endpoint and a statistical analysis plan refined based on prior study results have given Alkermes plc a positive Phase III readout that may be all the data it needs to file for approval of ALKS 5461 as an adjunctive therapy to treat refractory major depressive disorder.

The company will meet with FDA next quarter to discuss a submission. Alkermes expects the NDA will include data from Study 202, a Phase II trial that met the primary endpoint of Hamilton Depression Rating Scale (HAM-D17) in 2013, plus the FORWARD-3, -4 and -5 Phase III trials...