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    Home > Medical News > Latest Medical News > Lybalvi launches in the U.S. to treat schizophrenia and bipolar I disorder

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

    • Last Update: 2021-11-16
    • Source: Internet
    • Author: User
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    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
    .
    In terms of medication, in adult patients with bipolar type I disorder, Lybalvi can be used as a maintenance monotherapy, as a monotherapy or as an adjuvant therapy with lithium or valproate for the acute treatment of mania or mixed episodes

    .

    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)
    .
    Weight gain and clinically related metabolic problems are common side effects of atypical anti-schizophrenics

    .
    Olanzapine is a very effective antipsychotic drug, but its clinical use is limited by its high incidence of weight gain

    .
    Lybalvi is designed to provide the powerful antipsychotic effects of olanzapine while reducing the side effects on body weight and metabolism, thereby improving the safety of treatment

    .

    Schizophrenia and bipolar I disorder are complex chronic diseases, and safe and effective new drugs are still needed
    .
    Lybalvi is a new, once-daily, oral atypical antipsychotic drug designed to provide the efficacy of olanzapine while reducing weight gain caused by olanzapine

    .
    Lybalvi has 4 fixed-dose combinations, composed of 10mg doses of samidorphan and different doses of olanzapine (5mg, 10mg, 15mg, 20mg)

    .

    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 results of the pivotal ENLIGHTEN-1 efficacy study and the ENLIGHTEN-2 weight study from the ENLIGHTEN project have been published in peer-reviewed journals

    .

    The FDA approved Lybalvi through the 505(b)(2) regulatory pathway.
    The approval is based on data from 27 clinical studies, including 18 studies evaluating Lybalvi, 9 studies evaluating samidorphan separately, and FDA's olanzapine treatment of biphasic An investigation into the safety and effectiveness of type I disorders and schizophrenia was found

    .
    Data shows that olanzapine-related weight gain has nothing to do with disease

    .

    ENLIGHTEN-1 is a 4-week randomized, double-blind phase III study in patients with schizophrenia who are experiencing acute exacerbations.
    It compared the antipsychotic efficacy, safety and tolerability of Lybalvi with placebo

    .
    The results showed that the study reached the primary endpoint: Compared with the placebo group, the Lybalvi treatment group's Positive and Negative Symptom Scale (PANSS) scores showed a statistically significant reduction from baseline

    .
    The study also included an olanzapine treatment group, but not to compare the efficacy or safety of Lybalvi and olanzapine

    .
    Research data showed that compared with the placebo group, the olanzapine treatment group had a similar improvement in the PANSS score from baseline

    .

    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
    .
    The results showed that the study reached the common primary endpoint, indicating that compared with the olanzapine treatment group, the Lybalvi treatment group had a lower average weight gain from baseline at the 6th month of treatment, and at the 6th month of treatment The proportion of patients with a weight gain of ≥10% is lower

    .

    Note: The original text has been deleted

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

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