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INVEGA(TM) Gets Marketing Authority from EU to Treat Schizophrenia

a measure of functional improvement, as well as safety and tolerability assessments, were also included in the trials that supported the approval of INVEGA. The recommended dose of INVEGA is 6 mg per day, with a dose range of 3 mg to 12 mg per day depending on patient need.

Key findings of the program include:

-- In three six-week clinical trials, INVEGA demonstrated statistically significant symptom improvement on the PANSS versus placebo across all doses investigated. INVEGA was also superior to placebo on the PSP in these trials. In a chronic treatment trial, adult patients with schizophrenia who were treated with INVEGA showed a significantly longer time to relapse compared to placebo.
-- From the three six-week clinical trials, treatment-emergent adverse events(iv) (TEAEs) reported in 5% or more of subjects treated with INVEGA and at least twice the placebo rate for at least one dose included: akathisia (i.e. restlessness) and extrapyramidal disorder e.g. involuntary movements, tremors or muscle stiffness).
-- In the three six-week clinical trials, discontinuation rates due to TEAEs for all INVEGA dose groups were low and comparable to placebo (5% for placebo and for INVEGA: 2% for 3 mg, 6% for 6 mg, 4% for 9 mg, 5% for 12 mg).

Worldwide, it is estimated that 1 person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected in nearly equal numbers. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.

INVEGA was approved in the U.S. in December 2006, and was the first new prescription treatment for schizophrenia to be approved by the U.S. FDA since 2003. In April 2007, INVEGA was also approved by the FDA for the long
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