Journal of Clinical Psychiatry publishes data from ENLIGHTEN-Early study of Lybalvi in young adults early in their illness.- Alkermes plc.

ENLIGHTEN-Early evaluated the effect of Lybalvi compared to olanzapine on body weight in young adult patients (ages 16 to 39; mean age: 26 years) with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. To qualify for participation as "early in illness", patients had to have less than 24 weeks of previous treatment with antipsychotics and less than four years elapsed since the initial onset of active symptoms. Alkermes first reported the positive topline data from the ENLIGHTEN-Early study—including details on the primary and secondary endpoints in February 2022. Lybalvi is approved in the U.S. for the treatment of schizophrenia in adults, and for the treatment of bipolar I disorder in adults, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or as adjunct to lithium or valproate.

The full manuscript, titled "Olanzapine/Samidorphan in Young Adults with Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study," is now accessible online.

"Early identification and intervention are critical for people living with serious and complex mental health conditions, such as schizophrenia or bipolar I disorder," said René Kahn, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, and lead author. "The results from the ENLIGHTEN-Early study provide important data for clinicians treating patients early in disease and contribute to our understanding of Lybalvi as a treatment option for adult patients with schizophrenia or bipolar I disorder."

The ENLIGHTEN-Early study met its prespecified primary endpoint , demonstrating that patients treated with Lybalvi experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12. The mean percent change in body weight from baseline to Week 12 was 6.77% for olanzapine compared to 4.91% for Lybalvi (p=0.012). The safety profile of Lybalvi was consistent with previous studies. The most common adverse events reported for the Lybalvi treatment group were weight gain, somnolence and increased alanine aminotransferase and for the olanzapine treatment group were weight gain, somnolence and increased waist circumference.

ENLIGHTEN-Early Study Design : ENLIGHTEN-Early was a multicenter, randomized, double-blind, phase III study that evaluated the effect of Lybalvi compared to olanzapine on body weight over three months in young adults with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. Patients had to have less than 24 weeks of cumulative lifetime antipsychotic exposure and less than four years elapse since the initial onset of active symptoms. A total of 428 patients (aged greater than 16 and less than 40 years; mean: 26 years) were randomized in a 1:1 manner to receive either Lybalvi or olanzapine for up to 12 weeks, and the 408 patients who were dosed and had at least one post-baseline weight assessment were included in the efficacy analysis. The primary endpoint was percent change from baseline in body weight at Week 12. The secondary endpoints at Week 12, tested hierarchically, consisted of: the proportion of patients with 10% or more weight gain from baseline, the proportion of patients with 7% or more weight gain from baseline, mean change from baseline in waist circumference and mean change from baseline in CGI-S score within the Lybalvi treatment group. All participants who completed the double-blind portion of the study were eligible to continue in an open-label, long-term safety extension study and receive Lybalvi for up to an additional 48 months of treatment. The objective of the extension study is to assess the long-term safety, tolerability and durability of effect of Lybalvi.

Schizophreniform disorder exhibits symptoms similar to schizophrenia, but without sufficient duration for a diagnosis of schizophrenia (one to six months).

<> See- Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study.": René S. Kahn, MD, PhD; John M. Kane, MD; Christoph U. Correll, MD; Christina Arevalo, MS; et al., Published: March 22, 2023 Journal of Clinical Psychiatry.-J Clin Psychiatry 2023;84(3):22m14674.</>