Alkermes Expected To File Application With FDA For Schizophrenia Drug By Mid-2019

Biopharmaceutical company Alkermes Plc (Alkermes) recently announced positive results from its second phase 3 study, known as ENLIGHTEN-2. Compared to olanzapine, individuals experienced a reduction in weight gain when taking ALKS 3831 for the treatment of schizophrenia.

In response to the positive results, Alkermes is expected to file an application for U.S. Food and Drug Administration (FDA) approval of ALKS 3831 by mid-2019. Earlier this year, ALKS 3831 also demonstrated greater antipsychotic efficacy compared with placebo and a safety profile comparable to that of olanzapine.

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines . . .