GEN Exclusives

More »

GEN News Highlights

More »
Oct 29, 2010

FDA Gives Sunovion’s Schizophrenia Drug the Go-Ahead

  • 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.

Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content


GEN Jobs powered by connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »

Be sure to take the GEN Poll

Patient Access to Genetic Information

Do you think patients have the absolute right to gain access to their own genetic information from medical or clinical laboratories?

More »