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Lybalvi, a compound olanzapine formulation, was approved by the FDA to reduce weight gain caused by olanzapine
Lybalvi was approved by FDA to reduce weight gain caused by olanzapine. On June 1, 2021, Alkermes plc announced that the US FDA has approved its new drug Lybalvi to be marketed for the treatment of adult schizophrenia and bipolar I disorder as a maintenance monotherapy or manic or mixed episode Acute treatment, as a single agent or adjuvant treatment of lithium or valproate.
Lybalvi can provide olanzapine’s antipsychotic effects and less weight gain. The drug is scheduled for commercial sales in the fourth quarter of 2021.
LYBALVI is a double-layered tablet composed of olanzapine (olanzapine) and samidorphan (samidorphan). Samidorphan is a new molecular entity. The fixed dose of LYBALVI includes 10mg of samidorphan and 5mg, 10mg, 15mg. Or 20mg of olanzapine.
Olanzapine is an American Eli Lilly and Company. It was marketed in the United States in 1996. Olanzapine is the first non-classical antipsychotic approved for the long-term treatment of schizophrenia and the first approved for the treatment of acute bipolar disorder. Non-classical antipsychotics for mania.
Olanzapine is effective in controlling delusions, hallucinations, indifference, hostility, suspicion, social disorders and other diseases, and has become the first-line treatment for anti-schizophrenia.
At present, the research on the dosage form of olanzapine is relatively mature. In addition to conventional tablets, various dosage forms such as orally disintegrating tablets and instant films are on the market.
However, one of the main side effects of olanzapine is that it will significantly increase the weight of patients, thereby increasing their risk of other metabolic diseases.
Samidorphan is a new selective mu-opioid receptor antagonist that can reduce the weight gain caused by olanzapine by affecting the brain’s reward system.
The original intention of Lybalvi is to provide the antipsychotic effects of olanzapine while reducing the side effects on body weight and metabolism, thereby improving the safety and compliance of treatment.
In the ENLIGHTEN clinical development project, LYBALVI proved the antipsychotic efficacy, safety and tolerability. In the ENLIGHTEN-2 clinical development project, LYBALVI proved that compared with olanzapine, the weight gain of patients with schizophrenia was statistically significant. Significantly reduced.
The ENLIGHTEN clinical development project consists of two parts. Among them, ENLIGHTEN-1 is a 4-week randomized, double-blind phase III study, carried out in patients with schizophrenia who are experiencing acute exacerbations. It compares the resistance of ALKS3831 to placebo. Efficacy, safety and tolerability of psychosis.
ENLIGHTEN-2 is a 6-month randomized, double-blind phase III study conducted in patients with stable schizophrenia to evaluate the effects of ALKS3831 and placebo on body weight.
Olanzapine has a high market share in the global psychiatric field, and the patient’s medication cycle is long. The approval of LYBALVI is expected to have a certain impact on the olanzapine monotherapy market.
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.
(source:internet, reference only)