FDA permits Acadia to file NDA for psychosis drug without additional trial

04/12/2013 | Fox Business · Reuters

The FDA has allowed Acadia Pharmaceuticals to submit a new drug application for pimavanserin, its experimental drug for psychosis related to Parkinson's disease, without conducting an additional late-stage trial. Data from an initial Phase III trial and supporting studies is enough to support a regulatory filing, the agency said. Acadia, however, said it still needs to carry out more studies, and may not submit the new drug application until the end of 2014.

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Fox Business · Reuters

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