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Journal of Clinical Psychiatry Publishes Data from Alkermes' ENLIGHTEN-Early Study of LYBALVI® (olanzapine and samidorphan) in Young Adults Early in Their Illness
DUBLIN, March 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the publication of results from its phase 3 ENLIGHTEN-Early study of
About this update from Alkermes Plc
[{"type":"text","content":"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.\nThe 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.\n\"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.\"\n\"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 w...