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Summary of the FDA's rulings on Nuplazid, 2010-2020Summary of the FDA's rulings on Nuplazid, 2010-2020 2010: Approved 9-item SAPS as measure by which to determine efficacy in the phase 3 Parkinson's Disease Psychosis (020) trial. (34mg pimavanserin actually succeeded on the full-scale 20-item SAPS -- a point seldom acknowledged by those writing articles on the subject). April 2013: Waived the second phase 3 PDP trial based on the strength of the pivotal 020. Acadia cancelled its planned 021 trial as a result. September 2014: Granted Nuplazid breakthrough therapy status in PDP. November 2015: Accepted Acadia's New Drug Application with a Priority Review. March 2016: FDA Advisory Committee recommended Nuplazid for PDP with a 12-2 vote in favor of efficacy, 11-3 vote in favor of safety. April 2016: Approved Nuplazid for PDP with a black box warning (given based more on class of drug than any concerns about safety data). October 2017: Approved study design for phase 3, dementia-related psychosis (DRP) trial and granted Nuplazid breakthrough therapy status in DRP. September 2018: Issued a public statement vindicating the Nuplazid label: "The U.S. Food and Drug Administration (FDA) has completed a review of all postmarketing reports of deaths and serious adverse events (SAEs) reported with the use of Nuplazid (pimavanserin). Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings with Nuplazid, or findings that are inconsistent with the established safety profile currently described in the drug label." 2019: Said that phase 2 Major Depressive Disorder trial can serve as one of two pivotal studies supporting an sNDA. Also said that only 1 successful phase 3 trial of the two currently being run is necessary for an sNDA filing. March 2020: Reiterated its earlier view that a clinically meaningful outcome in the time-to-relapse phase 3 DRP study could serve as the basis of an sNDA submission. May 2020: Allowed Acadia to combine the data of two separately run phase 3 trials in MDD as a result of Covid-19 disruptions in enrollment. Reiterated earlier view that a successful phase 3 outcome could serve as the basis of an sNDA submission. Prediction: I expect the FDA to accept Acadia's supplemental submission in DRP with a priority review. I'm nearly certain that the FDA will approve Nuplazid for DRP, and with a much cleaner label than last time (though the black box may remain because it is assigned by class). |
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