Acadia Pharmaceuticals, Inc.
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The complaint alleges that Acadia misrepresented facts concerning their supplemental new drug application for NUPLAZID® (pimavanserin), which treats dementia-related psychosis.
Specifically, on July 20, 2020, it was announced by Acadia that the FDA accepted the sNDA for filing, stating that its pivotal study for the drug showed a meaningful reduction of psychosis symptoms, as well as a nearly 3X reduction in the risk of relapse for patients continuing on pimavanserin vs. placebo. Thereafter, Acadia repeatedly stated the FDA had not identified any potential review issues, reiterating the efficacy of the drug.
But the truth began to emerge on Mar. 8, 2021, when Acadia announced that on Mar. 3, 2021 they were informed by the FDA that it had identified deficiencies in the sNDA.