Alkermes reports results from Phase 3 study of LYBALVI

Alkermes announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment received in prior LYBALVI studies. LYBALVI is approved in the U.S. 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 as adjunct to lithium or valproate. In this global, open-label extension study, 523 participants received at least one dose of LYBALVI and 35.9% of participants completed the four-year treatment period. The safety profile of LYBALVI was consistent with previous studies. Patients’ symptoms of schizophrenia or bipolar I disorder remained stable with up to four years of treatment with LYBALVI, as measured by the Clinical Global Impression of Severity scale. Long-term treatment with LYBALVI was associated with minimal changes in body weight and waist circumference with up to four years of treatment. Similarly, there were generally minimal changes in lipid and glycemic parameters, including HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose and HbA1c over the measured time period. Overall, 60% of patients reported an adverse event. The most common AEs reported (greater than5%) were weight gain, headache, anxiety, insomnia, somnolence, nausea and weight decrease; most AEs were mild to moderate in severity.