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GEN News Highlights : Oct 29, 2010

FDA Gives Sunovion’s Schizophrenia Drug the Go-Ahead

Latuda is indicated for treatment in adults.

FDA approved Sunovion Pharmaceuticals’ Latuda tablets for the treatment of adults with schizophrenia. 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.

Four six-week, controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda, the FDA points out. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking placebo. FDA reviewed data from more than 40 clinical trials involving approximately 2,700 Latuda-treated adult subjects, Sunovion reports.

The most common adverse reactions reported by those in clinical trials were drowsiness, feelings of restlessness, akathisia, nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), as well as agitation.

“Latuda offers a once-daily treatment option that has been shown to be both effective and tolerable, adding to psychiatrists’ ability to address the challenging therapeutic needs of people with schizophrenia,” notes Antony Loebel, M.D., evp, clinical research and medical affairs at Sunovion.