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news.Invega extended release tablets have shown favorable long-term safety and tolerability during a one-year open-label extension study which is sponsored by Johnson & Johnson.
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In addition, patient symptom scores improved or were stable, on average, over the 52-week study. Symptoms of schizophrenia were reduced during long-term open-label treatment in 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 (PANSSa) scores.
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 6%. 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.
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.