American Psychiatric Association

December 13, 2018 | Editorial Board | View Online | Psychiatric News

In This Issue

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INDUSTRY BRIEFS

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

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.

Phase 2 Results for Lundbeck and Otsuka PTSD Combo Therapy Suggest Efficacy

Patients with posttraumatic stress disorder (PTSD) appear to experience greater symptom improvements when taking a combination of brexpiprazole and sertraline than those taking either medication alone, suggest the findings of a phase 2 trial. H. Lundbeck and Otsuka Pharmaceutical Co. Ltd. announced the results in November.

The trial, which involved 321 patients, assessed the efficacy, safety, and tolerability of monotherapy with either brexpiprazole or sertraline and therapy with both agents combined compared with placebo. The patients were evaluated using the Clinician-Administered PTSD Scale for DSM-5 at the beginning and end of the trial.

The companies plan to discuss the results with the Food and Drug Administration (FDA) and to evaluate, with the FDA, the continuation of a trial program.

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TEST YOUR KNOWLEDGE

Which of the following symptoms is associated with a worse prognosis in schizophrenia?

A. Hallucinations.

B. Disorganization.

C. Bizarre delusions.

D. Paranoia.

E. Mood lability.

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