Alkermes initiates ENLIGHTEN-2 Phase III trial of ALKS 3831 (samidorphan + olanzapine) for schizophrenia.

Alkermes has announced the initiation of ENLIGHTEN-2 ,the second of two core phase III studies for ALKS 3831 (samidorphan + olanzapine), an investigational novel oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia. ENLIGHTEN-2 will evaluate the weight gain profile of ALKS 3831 in patients with schizophrenia over a six-month treatment period compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain. ALKS 3831 is designed to provide patients with the strong efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.

ENLIGHTEN-2 is a multicenter, randomized, double-blind phase III study comparing weight gain of ALKS 3831 to olanzapine in approximately 540 patients with stable schizophrenia over six months. Safety and tolerability will also be evaluated in the study. 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. The objective of the extension phase of the study is to assess the safety and long-term tolerability of once-daily, oral ALKS 3831.

The ENLIGHTEN pivotal program* for ALKS 3831 is comprised of two key studies: a study evaluating ALKS 3831’s antipsychotic efficacy compared to placebo over four weeks and a study assessing weight gain with ALKS 3831 compared to olanzapine in patients with schizophrenia over six months. The program also includes supportive studies to evaluate the pharmacokinetic and metabolic profile of ALKS 3831, as well as long-term safety. Alkermes expects to use safety and efficacy data from the ENLIGHTEN pivotal program to serve as the basis for a New Drug Application (NDA) to be submitted to the FDA, pending study results.

* ENLIGHTEN-1 and ENLIGHTEN-2