Tag Archives: Alkermes

FDA declines to approve Alkermes opioid-based depression drug

(Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Alkermes Plc’s opioid-based depression treatment, citing the need for additional data to prove the effectiveness of the drug. The largely expected decision comes months after an advisory panel to the FDA strongly voted against the drug and raised questions on its safety… Read More »

Alkermes schizophrenia treatment meets main goals in late-stage study

(Reuters) – Alkermes Plc’s treatment for schizophrenia met the main goals in a late-stage study, with patients not gaining as much weight as those treated with commonly used antipsychotic drug olanzapine, the company said on Thursday. The high incidence of weight gain due to treatment from olanzapine limits the drug’s clinical use, Alkermes said in… Read More »