Lybalvi launches in the U.S. to treat schizophrenia and bipolar I disorder

Recently, Alkermes announced the launch of Lybalvi (olanzapine/samidorphan) in the US market, which is a new, once-daily atypical antipsychotic for the treatment of: (1) adult patients with schizophrenia; (2) biphasic Adult patients with type I disorder

Lybalvi was approved by the US FDA for the above two indications at the end of May this year

Lybalvi is a two-layer tablet made from a marketed antipsychotic drug olanzapine and a novel new molecular entity samidorphan (a novel selective μ-opioid receptor antagonist)

Schizophrenia and bipolar I disorder are complex chronic diseases, and safe and effective new drugs are still needed

In the ENLIGHTEN clinical development project, Lybalvi demonstrated the antipsychotic efficacy, safety, and tolerability, including the weight gain of schizophrenia patients who received Lybalvi treatment in the ENLIGHTEN-2 study was statistically significantly lower than the olanzapine treatment group

The FDA approved Lybalvi through the 505(b)(2) regulatory pathway.

ENLIGHTEN-1 is a 4-week randomized, double-blind phase III study in patients with schizophrenia who are experiencing acute exacerbations.

ENLIGHTEN-2 is a 6-month book, double-blind phase III study conducted in patients with stable schizophrenia to evaluate the effects of Lybalvi and placebo on body weight

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Original source: Alkermes Announces Commercial Availability of LYBALVI® for the Treatment of Schizophrenia and Bipolar I Disorder