Alkermes adcomm reveals SPCD paradox

Disagreement between FDA and Alkermes plc on how the data were analyzed took center stage at the panel meeting on the depression drug ALKS 5461. But the meeting also flushed out a chicken-and-egg problem for use of a novel trial design. FDA wants to see data from more trials before giving assurance about their acceptability, but without such assurances, companies are reluctant to run the trials needed to generate the data.

The best path for companies that want to use sequential parallel comparison design (SPCD) to reduce placebo responses may be to limit its use to Phase II proof of concept (POC), and work closely with FDA to develop best practices. ...