The dean at the University of Exeter Medical School discussed ongoing studies of pimavanserin and his thoughts on the FDA’s actions related to the agent.
“Compared to the treatments we currently have out there, [pimavanserin] has a huge, huge advantage. So, hopefully, any challenges in the FDA thought process can be addressed, because I think this would be a major benefit to the patients that we're treating.”
Patients with neurodegenerative disease did not experience negative impacts on cognitive function with up to 9 months of treatment compared to placebo, according to data from a recent review of 4 studies of pimavanserin (Nuplazid; Acadia Pharmaceuticals) presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22, by Clive Ballard, MD, professor, age-related diseases, and pro-vice-chancellor and executive dean, University of Exeter Medical School.
Ballard and colleagues found that the Mini-Mental State Examination (MMSE) score least squares mean (LSMO change from baseline to week 12) in was –0.25 (standard error [SE], 0.42) in study 019 and 0.0 (SE, 0.57) in study 032, and similar to placebo in both. LSM change from baseline to week 8 was 1.2 (SE, 0.21; n = 132) for pimavanserin and 0.5 (SE, 0.21; n = 128) for placebo in the interim analysis of study 046. The mean change from baseline to week 12 was 1.0 (SE, 0.22; n = 145) in the HARMONY study.
NeurologyLive spoke with Ballard to learn more about the ongoing studies of pimavanserin and his hopes for an FDA approval. The FDA previously issued a complete response letter to Acadia Pharmaceuticals due to deficiencies in their supplemental new drug application (sNDA) filing for pimavanserin for the treatment of DRP in April 2021.
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