Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Combination Drug Olanzapine/Samidorphan Intended to Treat Schizophrenia and Bipolar Disorder

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In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued against approval of the combination drug olanzapine/samidorphan, which is intended to treat schizophrenia and bipolar disorder, because the samidorphan component is only marginally effective in decreasing the weight gain seen with olanzapine, fails to improve many other indicators of metabolic health, and increases the risk of opioid overdose.