Alkermes’ Experimental Schizophrenia Drug Has Favorable Weight Profile in Phase 3 Trial

In November Alkermes announced the results from ENLIGHTEN-2, a phase 3 trial of its investigational schizophrenia drug ALKS 3831. Patients with schizophrenia who took ALKS 3831—a combination of olanzapine and the opioid receptor antagonist samidorphan—for six months did not gain as much weight as those taking olanzapine alone.

Patients in the ALKS 3831 group met both primary endpoints for the trial: they had a lower mean percent weight gain at six months compared with those in the olanzapine group, and a lower proportion of patients who gained 10 percent or more of their baseline body weight at six months.

The difference in weight gain between the two groups became apparent after the fourth week of the trial, and their rates of weight gain continued to diverge for the remainder of the study. At the sixth week, weight stabilized in the ALKS 3831 treatment group and remained flat for the rest of the study period.

Alkermes plans to submit a New Drug Application to the Food and Drug Administration in 2019. ■