Administration approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.
Latuda, an atypical antipsychotic, will be available as once-daily tablet. The drug is expected to be available in the U.S. during the first quarter of 2011.
Schizophrenia is a chronic, disabling and serious brain disorder that affects approximately 2.4 million American adults or 1 in 100 people.
Schizophrenia affects men and women equally. It occurs at similar rates in all ethnic groups around the world. Symptoms usually start between ages 16 and 30. Most of the time, people do not get schizophrenia after age 45. Schizophrenia rarely occurs in children, but awareness of childhood-onset schizophrenia is increasing.
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 These experiences can make people with the disorder fearful and withdrawn.
“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.”
The causes of schizophrenia are still unknown, so treatments focus on eliminating the symptoms of the disease. Treatments include antipsychotic medications and various psychosocial treatments.
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.
Other atypical antipsychotics include risperidone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel), ziprasidone (Geodon), aripiprazole (Abilify), and paliperidone (Invega).
Latuda, as with all other atypical antipsychotics, will have 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.