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