Benzinga | Oct 18, 2021 07:16AM EDT

Alkermes Announces Commercial Availability of LYBALVI For The Treatment Of Schizophrenia And Bipolar I Disorder

Alkermes plc (NASDAQ:ALKS) today announced that LYBALVI(r) (olanzapine and samidorphan) is now available by prescription in the United States (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 an adjunct to lithium or valproate. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.

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"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," said Todd Nichols, Chief Commercial Officer at Alkermes. "We have been building our commercial capabilities and presence in the antipsychotic market over the last five years and plan to leverage this experience as we expand our psychiatry franchise and bring LYBALVI to market. We look forward to engaging with healthcare providers and supporting patient access to LYBALVI as we drive awareness of this important new treatment option."

"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," said Michael Pollock, CEO of the Depression and Bipolar Support Alliance (DBSA). "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."

In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability. Results from the ENLIGHTEN program's pivotal ENLIGHTEN-1 study in schizophrenia, which demonstrated antipsychotic efficacy compared to placebo, and ENLIGHTEN-2 study in schizophrenia, which demonstrated LYBALVI's effect on weight gain compared to olanzapine, as well as their respective 52-week extension studies, have been published in peer-reviewed journals.1,2,3,4 The U.S. Food and Drug Administration (FDA) approved LYBALVI under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating LYBALVI and nine studies evaluating samidorphan alone, and the FDA's findings of safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia.