The FDA has approved Latuda (lurasidone HCI) tablets for the treatment of adult schizophrenia.
Every year, the mental disorder affects about 1 percent of Americans ages 18 and older. Symptoms include hallucinations, suspiciousness, disordered thinking and behavior, and delusions. The most common type of hallucination is hearing voices that other people don't hear.
"Schizophrenia can be a devastating illness requiring lifelong treatment," Dr. Thomas Laughren, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available."
Latuda is classed as an atypical antipsychotic drug. All prescriptions of atypical antipsychotics contain a warning alerting prescribers to an increased risk of death associated with using these drugs "off-label" to treat behavioral problems in older people with dementia-related psychosis.
Four six-week controlled studies of adults with schizophrenia found that patients treated with Latuda had fewer symptoms of schizophrenia than those taking a placebo.
The most common side effects were drowsiness, feelings of restlessness and the urge to move (akathisia), nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), and agitation.
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