DUBLIN, March 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the publication of results from its phase 3 ENLIGHTEN-Early study of LYBALVI® (olanzapine and samidorphan) in the peer-reviewed publication, the Journal of Clinical Psychiatry. 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 publication of the ENLIGHTEN-Early data demonstrates Alkermes' dedication to expanding the body of evidence supporting the use of LYBALVI for adults living with schizophrenia or bipolar I disorder," said Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes. "We look forward to supplementing this clinical data with real-world insights as healthcare providers and patients gain experience with LYBALVI."
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 DesignENLIGHTEN-Early was a multicenter, randomized, double-blind, phase 3 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 ≥16 and