THURSDAY, Oct. 28, 2010 (HealthDay News) -- Lurasidone HCI (Latuda) tablets have been approved by the U.S. Food and Drug Administration to treat adult schizophrenia, which affects about 1 percent of the nation's adult population in a given year, the agency said Thursday in a news release.
The disorder's primary symptoms include hallucinations, delusions, disordered behavior and suspiciousness, the agency said. Among the most common hallucinations is hearing voices that other people don't hear.
Latuda is an atypical antipsychotic drug. All medications in this class contain a boxed label warning that prescribing them for unapproved use in people with dementia-related psychosis increases the risk of death. No atypical antipsychotic drug is sanctioned for people with dementia-related psychosis, the agency warned.
Latuda was approved based on four six-week clinical studies of adults with schizophrenia. Common adverse reactions included drowsiness, restlessness, nausea, an uncontrolled urge to move (akathisia), and movement disorders including tremors, muscle stiffness and slow movement.
Latuda is produced by Sunovion Pharmaceuticals, based in Fort Lee, N.J.
The U.S. National Institute of Mental Health has more about schizophrenia.