Alkermes Announces Positive Topline Results From ENLIGHTEN-Early Phase 3b Study of LYBALVI in Patients Early in Illness
LYBALVI Demonstrated Less Weight Gain Compared to Olanzapine in Patients With Schizophrenia, Schizophreniform Disorder or Bipolar I Disorder
Alkermes plc announced positive topline results from ENLIGHTEN-Early, a phase 3b study that evaluated the effect of LYBALVI® (olanzapine and samidorphan) 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. The study met its pre-specified primary endpoint, as patients treated with LYBALVI experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12. Consistent with the ENLIGHTEN-2 pivotal study, a numerical difference in average weight gain between treatment arms was observed early in treatment and continued to separate through the study's prespecified primary endpoint. LYBALVI is approved for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes as monotherapy or an adjunct to lithium or valproate.
"We're pleased to share topline results from the ENLIGHTEN-Early study, in which LYBALVI demonstrated less mean weight gain compared to olanzapine in patients early in illness with schizophrenia, schizophreniform disorder or bipolar I disorder. These results complement the weight gain profile of LYBALVI shown in the ENLIGHTEN-2 pivotal study and reinforce the potential of LYBALVI as a new treatment option for adults living with schizophrenia or bipolar I disorder," said Craig Hopkinson, M.D., Executive Vice President of Research & Development and Chief Medical Officer at Alkermes.
"Olanzapine is well-known as an efficacious medicine but is often not used as a first-line treatment for early-in-illness patients due, in part, to concerns about weight gain," said Christoph Correll, M.D., Professor of Psychiatry and Molecular Medicine at Hofstra Northwell School of Medicine. "We're encouraged to see the positive results of this study in patients who have had less exposure to antipsychotic therapy and may be particularly susceptible to olanzapine-induced weight gain."