Industry Briefs

Alkermes Begins Phase 3 Trial of Antipsychotic

Last week, Alkermes announced the initiation of a second phase 3 trial for the once-daily oral atypical antipsychotic medication ALKS-3831 (combined tablet of samidorphan and olanzapine) intended for the treatment of schizophrenia.

The trial, known as ENLIGHTEN-2, is a multicenter, randomized, double-blind phase 3 study that is comparing weight gain, safety, and tolerability of ALKS-3831 with that of olanzapine monotherapy in approximately 540 patients with schizophrenia over six months.

All participants in the double-blind portion of the study will be eligible to continue in an open-label safety study of ALKS-3831 for an additional 12 months, which will assess the safety and long-term tolerability of the medication.

The results of phase 2 trials, released last year, showed ALKS-3831 to be as effective at reducing symptoms of schizophrenia as olanzapine with less weight gain than that of olanzapine monotherapy over three months (Psychiatric News, May 1, 2015).

FDA Updates Iloperidone Label on Adverse Events

Last month, the Food and Drug Administration updated the label of Fanapt (iloperidone) tablets after postmarketing reports indicated patients taking the medication may be at an increased risk for hypersensitivity reactions (including anaphylaxis; angioedema; throat tightness; oropharyngeal swelling; swelling of the face, lips, mouth, and tongue; urticaria; rash; and pruritus). ■