J&J Psychotic Drug Cleared By FDA
Posted on: Thursday, 21 December 2006, 12:12 CST
The FDA has approved Johnson & Johnson's Invega, a new antipsychotic for the treatment of schizophrenia, making it the first treatment approved for this indication since 2003.
However, the drugs label will also contain an unexpected warning that it can cause side effects such as heart problems.
Invega contains paliperidone, the active ingredient derived from risperidone, and is delivered through an extended-release technology. Risperidone is indicated for the treatment of schizophrenia and for bipolar I disorder and also carries warnings about risks of adverse effects.
"New and efficacious treatment options, like Invega, provide significant opportunities for more people with schizophrenia to manage their disease as they work with their treatment teams to live more fulfilling and productive lives," said Michael Fitzpatrick, executive director of the National Alliance on Mental Illness.
In six-week clinical trials, Invega demonstrated statistically significant symptom improvement versus placebo across all doses investigated. Invega will be available in the US in January 2007.
Source: Datamonitor
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