Alkermes sinks on Phase III depression data

Alkermes plc (NASDAQ:ALKS) fell $26.73 (44%) to $33.69 on Thursday, losing more than $4 billion in market cap, after its ALKS 5461 missed the primary endpoint of change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores vs. placebo in two Phase III trials as adjunctive therapy to treat major depressive disorder (MDD).

The double-blind FORWARD-3 and FORWARD-4 trials both used a sequential parallel comparison design (SPCD), a two-stage process intended to reduce placebo response by weeding out patients on placebo who show at least a 50% improvement. Alkermes was the first sponsor to use the trial design, seeking to replicate a Phase II success in Phase III (see BioCentury, Nov. 18, 2013). ...