Alkermes sees swift turnaround for rejected schizophrenia med as FDA accepts resubmission

Alkermes says its plant in Wilmington, Ohio, can now produce its schizophrenia and bipolar I hopeful after the FDA gave it the all-clear. (Alkermes)

After suffering a complete response letter a little over a month ago, Alkermes quickly sorted out the manufacturing shortfalls that blighted its experimental med—and now, the FDA has set a potential approval date this summer....

Its drug combines olanzapine, the active ingredient of Zyprexa, with samidorphan, an opioid antagonist designed to counter the weight gain and metabolic side effects of Eli Lilly’s antipsychotic.

It will now focus on its marketing plans, should the med gain that summer approval, though sales aren't likely to be an easy task, either. During its AdComm in the fall, the panelists' main question was how samidorphan might affect patients taking opioids like morphine or oxycodone.