FDA: Paliperidone for the treatment of schizophrenia
The FDA (Food and Drug Administration) has approved Invega (paliperidone) release formulation prolungato.Il paliperidone is a new atypical antipsychotic for treatment of schizophrenia, the active metabolite of risperidone. Effectiveness Invega in the acute treatment of schizophrenia was evaluated in 3 placebo-controlled trials lasting 6 weeks. Clinical trials involved 1600 patients from 23 countries. Invega has been shown to improve symptoms in a statistically significant compared to placebo at all doses tested (3 to 15mg/die). Invega is also superior to placebo at the scale PSP (Personal and Social Performance). The most common adverse reactions reported in clinical trials were: akathisia and extrapyramidal disorders (involuntary movements, tremors and muscle stiffness). The rate of treatment discontinuation due to adverse events for subjects treated with Invega was Low: 2% for 3mg, 6mg 6%, 4% for 9mg, 5% for 12mg, vs. 5% for placebo.
Source: Johnson & Johnson, 2006
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