The Food and Drug Administration (FDA) has approved Latuda
(lurasidone HCl) tablets for the treatment of adults with schizophrenia.
Schizophrenia affects about one percent of the U.S.
population, ages 18 years and older, in a given year. The most prominent
symptoms include hallucinations, delusions, disordered thinking and behavior,
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disorder fearful and withdrawn.
Lengthy treatment
"Schizophrenia can be a devastating illness requiring
lifelong treatment," said Thomas Laughren, M.D., 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 behavioral problems in older people with dementia-related psychosis. No
drug in this class is approved to treat patients with dementia-related
psychosis.
Drug testing
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, N.J.
