Nov 5 2013
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 Phase 3 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.
"This meeting was a critical milestone for advancing Reviva's lead product," said Laxminarayan Bhat, Ph.D., President and Chief Executive Officer of Reviva. "We are very pleased with the positive outcome and the clear feedback from the FDA at our End-of-Phase 2 meeting."
Reviva plans to initiate Phase 3 trials in early 2014 and anticipates filing a NDA in 2016. "There is a major unmet medical and public health need for a well-tolerated and highly effective therapy for schizophrenia," said Marc Cantillon, M.D., Chief Medical Officer of Reviva. "The encouraging safety and efficacy results from the Phase 2 clinical trial of RP5063 provide strong support for the successful Phase 3 clinical development."
Reviva Pharmaceuticals, Inc.