FDA doc­u­ments raise opi­oid abuse po­ten­tial but pave a path to­ward bad­ly-need­ed ap­proval for Alk­er­mes

Alk­er­mes’ lat­est at­tempt to get an in-house drug past the FDA seems to be go­ing bet­ter than the pre­vi­ous one.

The agency re­leased their as­sess­ment of ALKS-3831, the Irish biotech’s ex­per­i­men­tal drug for schiz­o­phre­nia and bipo­lar I dis­or­der, ahead of an ad­vi­so­ry com­mit­tee hear­ing Fri­day. And while FDA re­view­ers flagged at least one key is­sue, the doc­u­ments over­all point to a far eas­i­er path to ap­proval than Alk­er­mes faced the last time they went to reg­u­la­tors, when the re­jec­tion of a con­tro­ver­sial opi­oid for de­pres­sion helped trig­ger lay­offs and a strate­gic shift at the Richard Pops-led com­pa­ny.

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