INVEGA Shows Long-Term Safety Profile In Patients With Schizophrenia

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INVEGA (paliperidone) Extended-Release Tablets showed favorable long-term safety and tolerability during a one-year open-label extension (OLE) study, according to a new, company-sponsored study. In addition, patient symptom scores improved or were stable, on average, over this 52-week study.(1)

The study was designed to evaluate the long-term safety of INVEGA, an oral, atypical anti-psychotic approved for the treatment of schizophrenia. Discontinuations due to treatment-emergent adverse events (TEAEs) and the total number of serious TEAEs were both six percent. Other assessments such as cardiovascular, metabolic and weight-related assessments showed either no mean change or clinically minimal change as a result of the treatment. Symptoms of schizophrenia were reduced during long-term open-label treatment in those patients that transitioned from placebo to INVEGA and were maintained in those that were previously on INVEGA as assessed by the Positive and Negative Symptoms of Schizophrenia (PANSS(a)) scores.

"This long-term extension trial adds to the body of knowledge regarding the safety of INVEGA in the longer-term treatment of schizophrenia. The study also suggests that symptom control is maintained over time," said George M. Simpson, MD, Professor of Research, Director Outpatient Clinic, Keck School of Medicine of the University of Southern California. Dr. Simpson is a principal investigator of the study and a consultant to its sponsors Ortho-McNeil Janssen Scientific Affairs, LLC, Johnson & Johnson Pharmaceutical Research & Development, LLC, and Janssen, L.P., the company that markets INVEGA.

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The study consisted of 235 patients (154 male; 81 female) who had participated in the prior double-blind (DB) recurrence prevention study. This study demonstrated a significantly longer time to relapse in patients treated with INVEGA compared with those who received placebo and had been brought to an early 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.

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