- Ahead of Acadia Pharmaceuticals Inc's ACAD FDA AdComm meeting on Friday, the agency officials released their briefing documents, revealing a mixed bag of opinions.
- The company's resubmitted supplemental New Drug Application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis (ADP) has a target action date of August 4.
- Initially, the FDA considered the Phase 2 trial, dubbed Study 019, insufficiently adequate and well-controlled, one of many reasons for the CRL, agency documents said.
- Related: Analysts Say Acadia's Negative Pain Data Increases Focus On Pimavanserin For Alzheimer's-Related Psychosis.
- Study 019 involved patients whose psychotic symptoms were not clear or who received "exclusionary medications" when randomized into the study, the documents said.
- Acadia reconducted its primary endpoint analysis to measure the impact of these deviations, and the results came in favor of pimavanserin.
- Also See: Acadia Slims Nuplazid Label Expansion Application For Alzheimer's Disease Psychosis.
- "At this time, the Agency has determined that the study was designed with features that could allow it to be considered an adequate and well-controlled trial suitable for regulatory decision making," the documents read.
- "However, questions remain related to whether the methods of assessment of subjects' response are well defined and reliable."
- Price Action: ACAD shares are up 12.8% at $18.33 during the market session on the last check Wednesday.
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