The US Food and Drug Administration approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.
Schizophrenia affects about 1 per cent of the US population, ages 18 years and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behaviour, and suspiciousness. Hearing voices that other people don't hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.
“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. “Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.”
Latuda is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioural problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.
Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).
The most common adverse reactions reported by those in clinical trials 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.
Latuda is manufactured by Sunovion Pharmaceuticals Inc. of Fort Lee, New Jersey.