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INVEGA(TM) Shows Favorable Long-Term Safety Profile in a One-Year Study of Patients With Schizophrenia
Date:12/12/2007

arly completion when efficacy was established at its interim analysis. Of the 235 patients, 72 received INVEGA, 80 received placebo, and 83 were enrolled directly into the OLE due to the early completion of the DB phase. These 83 patients had received INVEGA for a variable period of time prior to their entry into the OLE (sometime during the initial 14-week combined run-in and stabilization period).

Patients were 18-65 years old and met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, criteria of schizophrenia for at least one year). The mean age of patients who entered was 35.8 years old.

Treatment in the OLE phase was initiated at a dose of 9mg/day with changes in dose increments of 3mg/day, to a maximum of 15mg/day or minimum of 3mg/day permitted.

Sixty percent of patients completed the OLE. TEAEs occurred in 69 percent of patients. The discontinuation rate due to adverse effects was 6 percent (n=12). TEAEs that occurred with an incidence of 8 percent or more were tremor (13 percent; n=31), akathisia (11 percent; n=25), headache (8 percent; n=19), and insomnia (8 percent; n=18).

Safety for INVEGA was evaluated from OLE baseline to end point, in the context of a systematic review of TEAEs, clinical laboratory tests, body weight and body mass index, electrocardiograms and EPS incidence using the Simpson Angus Rating Scale, Barnes Akathisia Rating Scale and Abnormal Involuntary Movement Scale. Efficacy was evaluated as a secondary endpoint using the total PANSS score, with a negative score indicating a worsening of symptoms.
The mean changes observed in the total PANSS were:

* -15.7 +/- 20.09 for patients who had been treated with placebo during

DB, and who were then started on INVEGA during the OLE:

* -6.3 +/- 18.91 for those initially assigned to INVEGA during DB, and

then continued on INVEGA during the OLE; and

* -3.9 +/- 13.85 for those 83 patients who had previously
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SOURCE Johnson & Johnson
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