Lybalvi for schizophrenia, bipolar disorder shows positive phase 3b results
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Alkermes announced positive topline results from its phase 3b study of Lybalvi in young adults with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness.
Regarding the pre-specified primary endpoint, results of the ENLIGHTEN-Early study showed Lybalvi (olanzapine and samidorphan, Alkermes) was associated with statistically significantly less weight gain than olanzapine alone at 12 weeks (mean percent change from baseline body weight, 6.77% for olanzapine vs. 4.91% for Lybalvi; P = .012) in patients aged 16 to 39 years (mean age, 26 years).
"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,” Craig Hopkinson, MD, executive vice president of research and development and chief medical officer at Alkermes, said in a press release. “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.”
Secondary endpoint results included 30.4% of patients on olanzapine and 21.9% on Lybalvi having gained 10% or more of their baseline body weight at 3 months and 44.8% on olanzapine and 33.1% on Lybalvi having gained 7% or more of their baseline body weight at 3 months. A total of 63.5% of patients who received Lybalvi and 63.3% who received olanzapine reported adverse events while on treatment, with the most common for the Lybalvi treatment group being weight gain, somnolence and increased alanine aminotransferase. For the olanzapine treatment group, these were weight gain, somnolence and increased waist circumference. A total of 3.8% of patients who received Lybalvi reported serious adverse events compared with 3.7% of patients who received olanzapine during the treatment period.