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Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
Date:8/3/2009

reated patients (P < 0.0001). During the double-blind phase of the study, fewer patients treated with INVEGA(R) SUSTENNA(TM) experienced a relapse (10% [n=15/156]) compared with those in the placebo group (34% [n=53/156]).

Because maintenance of efficacy was demonstrated, the trial was ended early. Patients on INVEGA(R) SUSTENNA(TM) 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(R) SUSTENNA(TM). As such, INVEGA(R) SUSTENNA(TM) 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(R) SUSTENNA(TM) 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(R) SUSTENNA(TM) demonstrates our commitment to providing valuable novel therapies for schizophrenia. INVEGA(R) SUSTENNA(TM) 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
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SOURCE Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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