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INVEGA(R) Approved as the First and Only Treatment for Schizoaffective Disorder
Date:7/31/2009

ion to reduce to 9 mg. In addition to study medication, subjects were permitted to receive concomitant treatment with a mood stabilizer and/or antidepressant, provided these medications had been given at a stable dose within 30 days of screening. Approximately half the subjects enrolled received ongoing treatment with a mood stabilizer and/or antidepressant during the studies. The most commonly used mood stabilizers were valproate and lithium. The most commonly used antidepressants were SSRIs and SNRIs.

Efficacy was evaluated using the positive and negative symptom scale (PANSS), a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression. As secondary outcomes, mood symptoms were evaluated using the Hamilton Depression Rating Scale (HAM-D-21) and the Young Mania Rating Scale (YMRS).

The INVEGA(R) group in the flexible-dose study (dosed between 3 and 12 mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of INVEGA(R) in the 2 dose-level study (12 mg/day with option to reduce to 9 mg/day) were each superior to placebo in the PANSS. Numerical improvements in mood symptoms were also observed, as measured by the HAM-D-21 and YMRS. In the lower dose group of the 2 dose-level study (6 mg/day with option to reduce to 3 mg/day), INVEGA(R) was not significantly different from placebo as measured by the PANSS.

The most common adverse events (incidence greater than or equal to 5% and at least twice that for placebo) were extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increase, and nasopharyngitis.

"Schizoaffective disorder is a chronic, disabling condition," said Husseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development. "This new indication for INVEGA(R) fur
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SOURCE Janssen
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