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FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
Date:7/31/2009

rated, the trial was ended early. Patients on INVEGA SUSTENNA experienced a significant delay in time to relapse compared to placebo. Patients on placebo had a 3.6 fold higher incidence of experiencing relapse versus INVEGA SUSTENNA. As such, INVEGA SUSTENNA has the potential to be of tremendous benefit for physicians, caregivers and patients.

In clinical trials, the most common adverse events (incidence greater than or equal to 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.

"INVEGA SUSTENNA provides healthcare professionals the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies," said Husseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development. "The approval of INVEGA SUSTENNA demonstrates our commitment to providing valuable novel therapies for schizophrenia. INVEGA SUSTENNA has a demonstrated safety profile that can help healthcare professionals address the issue of medication adherence and can also help many patients delay the time to relapse."

Visit http://www.INVEGASUSTENNA.com for full prescribing information.

IMPORTANT SAFETY INFORMATION FOR INVEGA(R) SUSTENNA(TM)

INVEGA(R) SUSTENNA(TM) is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA(R) SUSTENNA(TM) in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.

Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEG
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SOURCE Janssen
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