Lybalvi now available for adults with schizophrenia, bipolar 1 disorder

Alkermes has announced that its schizophrenia/bipolar 1 disorder treatment Lybalvi is now available by prescription in the U.S.

The once-daily, oral atypical antipsychotic treatment (olanzapine and samidorphan, Alkermes) is indicated for adults with schizophrenia and for adults with bipolar 1 disorder as a maintenance monotherapy or for the acute treatment of manic or mixed episodes as monotherapy or in combination with lithium or valproate.

"We have been building our commercial capabilities and presence in the antipsychotic market over the last 5 years and plan to leverage this experience as we expand our psychiatry franchise and bring Lybalvi to market,” Todd Nichols, chief commercial officer at Alkermes, said in a press release. “We look forward to engaging with health care providers and supporting patient access to Lybalvi as we drive awareness of this important new treatment option."

The olanzapine/samidorphan combination showed antipsychotic efficacy, safety and tolerability in the ENLIGHTEN clinical development program. The ENLIGHTEN program’s pivotal ENLIGHTEN-1 study in schizophrenia demonstrated antipsychotic efficacy vs. placebo for the combination treatment, and ENLIGHTEN-2 showed its positive effect on weight gain compared with olanzapine. The FDA based its approval of olanzapine/samidorphan on data from 27 clinical studies, as well as on the administration’s findings of safety and effectiveness of olanzapine in treating bipolar 1 disorder and schizophrenia.