Alkermes plc. (NASDAQ: ALKS) has announced the availability of LYBALVI (olanzapine and samidorphan) in the US by prescription in schizophrenia treatment and for bipolar I disorder treatment as well as a maintenance monotherapy or for acute mixed or manic episodes treatment. LYBALVI can also be used as a monotherapy or adjunct to valproate or lithium. It is an oral once-daily atypical antipsychotic comprising an established antipsychotic agent, olanzapine, and a new chemical entity samidorphan.
LYBALVI commercially available for prescription
Alkermes Chief Commercial Officer Todd Nichols said, “Alkermes has long been focused on the research, development and manufacture of new medicines that seek to address real-world patient needs and is committed to being a leader in the treatment of serious mental illness. Today, we’re pleased to announce the commercial availability of LYBALVI, our first oral antipsychotic medicine, for adults living with schizophrenia or bipolar I disorder. We look forward to engaging with healthcare providers and supporting patient access to LYBALVI as we drive awareness of this important new treatment option.”
New treatment available for bipolar I disorder
Depression and Bipolar Support Alliance (DBSA) CEO Michael Pollock commented, “Patients living with bipolar I disorder or schizophrenia commonly cycle through multiple therapeutic options in the course of their treatment journey. The availability of a new, efficacious and differentiated treatment option is a significant development for patients as they make treatment decisions with their healthcare provider. We appreciate Alkermes’ long-standing dedication to the challenges faced by people living with serious and complex mental health conditions and to the development of medicines that seek to address unmet patient needs.”
LYBALVI showed antipsychotic safety, tolerability, and efficacy effects in the ENLIGHTEN clinical development study. In addition, the company has published ENLIGHTEN study results in schizophrenia showing antipsychotic effect compared to placebo and ENLIGHTEN 2 trial showing LYBALVI’s impact on weight gain relative to olanzapine in a peer-reviewed journal.
