FDA staff high­lights neu­ro­log­i­cal safe­ty con­cerns with Durec­t's pain drug

Days af­ter sting­ing tri­al fail­ure forced the Cal­i­for­nia com­pa­ny to aban­don its pso­ri­a­sis pro­gram, FDA staff re­view­ers is­sued a re­view that high­light­ed the risk of neu­ro­log­i­cal side ef­fects with Durect Corp’s long-act­ing anes­thet­ic, posimir, for pa­tients with post-sur­gi­cal anal­ge­sia.

Posimir, an ex­tend­ed-re­lease for­mu­la­tion of the ap­proved anes­thet­ic — bupi­va­caine — has a check­ered past. The com­pa­ny, which orig­i­nal­ly part­nered with No­var­tis on the pro­gram, first sub­mit­ted an ap­pli­ca­tion to mar­ket the drug on the ba­sis of sev­en tri­als, in­clud­ing two piv­otal stud­ies in pa­tients un­der­go­ing her­nia re­pair and shoul­der surgery. The FDA spurned the ap­pli­ca­tion in 2014 over safe­ty con­cerns.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER