ARTICLE | Product Development
New designs in depression
Alkermes advancing new trial design to eliminate placebo problems in depression
November 18, 2013 8:00 AM UTC
An innovative clinical trial design developed by a pair of academics is helping drug companies eliminate the placebo response that has dogged development of drugs for depression. Next year, Alkermes plc will become the first sponsor to see whether a sequential parallel comparison design can replicate a Phase II success in a Phase III trial.
In October, Alkermes received Fast Track designation for ALKS 5461 as an adjunctive therapy to treat major depressive disorder (MDD) and said it would begin a Phase III study in 2014 using sequential parallel comparison design (SPCD)...