[{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Journal of Clinical Psychiatry Publishes Data from Alkermes' Phase 3 ENLIGHTEN-1 Efficacy Study","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small 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Results From Long-Term, Open-Label Safety and Durability of Treatment Effect Study of LYBALVI\u00ae (olanzapine and samidorphan)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Samidorphan L-Malate
Lybalvi (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug. It is approved by USFDA for treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder.
LYBALVI (olanzapine and samidorphan), an atypical antipsychotic drug approved in U.S. for treatment of adults with schizophrenia and for treatment of adults with bipolar I disorder.
In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
Highlights of the presentations include: A clinical overview of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831, consisting of 18 clinical studies, evaluating LYBALVI's antipsychotic efficacy and weight mitigation profile along with its safety data.
The company's presentations included new exploratory analyses from the phase 3 ENLIGHTEN-2 study of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831.
U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.
The AdCom will likely question whether or not ALKS-3831, a formulation of samidorphan and generically available olanzapine, provided a clinically meaningful reduction in the common weight gain side effect versus olanzapine.
The committees voted 16-1 that samidorphan meaningfully mitigates olanzapine-associated weight gain and also ruled that the safety profile of the drug has been adequately characterised by 13-3.
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.
The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder.
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