The U.S. FDA approves an innovative oral compound drug for the treatment of schizophrenia and bipolar I disorder

On June 1, 2021, Alkermes announced that the US FDA has approved its new drug Lybalvi (formerly known as ALKS 3831) for the treatment of adult schizophrenia and bipolar I disorder.

Olanzapine is a psychiatric drug that has been marketed, but one of its main side effects is that it will significantly increase the weight of patients, thereby increasing their risk of other metabolic diseases.

▲The role of Lybalvi (picture source: Alkermes official website)

In the clinical development project of the drug ENLIGHTEN, Lybalvi proved its good effectiveness, safety and tolerability as an antipsychotic.

▲Lybalvi significantly reduced the weight gain of patients in the ENLIGHTEN-2 clinical trial (picture source: Alkermes official website)

Bipolar disorder is a disease that can cause severe fluctuations in mood, vitality, and ability to perform daily tasks.

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Reference materials:

[1] Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder.