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Trials & Filings

Reviva Schizophrenia Candidate Cleared for Phase III

End-of-Phase II meeting with FDA goes well

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Reviva Pharmaceuticals successfully completed its End-of-Phase II meeting with the FDA for its lead investigational antipsychotic drug, RP5063. The FDA indicated that the data from the completed Phase II clinical studies of RP5063 support the start of pivotal Phase III studies.

During the meeting, FDA provided clear guidance related to the proposed Phase III development plan: overall size and design of the planned phase III studies, the primary endpoints, statistical analysis, non-clinical toxicology, clinical pharmacology and manufacturing plans for both drug substance and drug products for the proposed filing of an NDA for schizophrenia. Reviva plans to initiate Phase III trials in early 2014 and anticipates filing a NDA in 2016.

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