New antipsychotic drug!

Lybalvi can provide the efficacy of olanzapine, reduce the side effects of body weight and metabolism, and improve the safety of treatment
.

October 18, 2021 /Bio Valley BIOON/ --Alkermes is a fully integrated Irish biopharmaceutical company dedicated to the development of innovative drugs for the treatment of central nervous system (CNS) diseases and tumors
.

Recently, the company announced the launch of Lybalvi (olanzapine/samidorphan) in the US market, which is a new, once-daily atypical antipsychotic drug for the treatment of: (1) adult patients with schizophrenia; (2) double Adult patients with phase 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

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

Lybalvi is a new, once-a-day, oral atypical antipsychotic drug designed to provide the efficacy of olanzapine while reducing weight gain caused by olanzapine

Lybalvi active pharmaceutical ingredients (picture source: medicaltrend.
org)

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

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

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

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