Reviva Pharmaceuticals Announces Successful End-of-Phase 2 Meeting With FDA for RP5063

by / Wednesday, 06 February 2013 / Published in Latest posts

SAN JOSE, Calif.–(BUSINESS WIRE)–Reviva Pharmaceuticals, Inc., (Reviva), a privately held pharmaceutical company focused on the discovery and development of new, safer and highly effective therapies for chronic indications, announced today the successful completion of an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) for its lead, new investigational antipsychotic drug, RP5063. The FDA indicated that the data from the completed Phase 2 clinical studies of RP5063 support the start of pivotal Phase 3 studies.

During the meeting, FDA provided clear guidance related to the proposed Phase3 development plan: overall size and design of the planned phase 3 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 a New Drug Application (NDA) for schizophrenia. +Read More

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