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. 2021 Jun 15;6(2):61.
doi: 10.3390/geriatrics6020061.

Palatability and Swallowability of Pimavanserin When Mixed with Selected Food Vehicles: An Exploratory Open-Label Crossover Study

Mark Forman  1 , Alex Kouassi  1 , Teresa Brandt  1 , Lee Barsky  1 , Cynthia Zamora  2 , Daryl Dekarske  1
Affiliations

Palatability and Swallowability of Pimavanserin When Mixed with Selected Food Vehicles: An Exploratory Open-Label Crossover Study

Mark Forman et al. Geriatrics (Basel). .

Abstract

Dysphagia (difficulty swallowing) affects up to 13% of persons 65 years and older and 51% of older persons in nursing homes and can contribute to reduced adherence to oral medications. This was an exploratory, single-center, open-label, randomized, crossover study in healthy older adult participants. Primary objectives were evaluation of palatability (taste) and swallowability of the contents of pimavanserin 34 mg capsules mixed with selected soft foods or a liquid nutritional supplement. Secondary objectives included evaluation of additional palatability endpoints and ease of capsule manipulation for mixing. A total of 18 healthy, older adult participants (mean age 65 years) were included. Mean participant ratings for all food vehicles were "moderately like" to "neither like nor dislike" for palatability and "very easy" to "somewhat easy" for swallowability. Capsule manipulation to allow sprinkling of contents was rated "very easy" or "somewhat easy" by most participants. There were five treatment-emergent adverse events, all mild; two were deemed related to study treatment. The palatability and swallowability of pimavanserin was considered acceptable when administered with certain soft foods or a liquid nutritional supplement by the study participants.

Keywords: Parkinson’s disease; dysphagia; medication administration; pimavanserin; surveys and questionnaires; swallowing difficulties.

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Conflict of interest statement

M.F., A.K. and L.B. were employees of Acadia Pharmaceuticals Inc. at the time of this study. T.B. and D.D. are employees of and may hold stock and/or stock options in Acadia. Pharmaceuticals Inc. C.Z. is an employee of Worldwide Clinical Trials.

Figures

Figure 1
Figure 1
Study design. * Daily testing assessments were divided into 2 parts. In Part 1, participants (n = 2) assessed pimavanserin 34 mg mixed with 15 mL or 30 mL food vehicle to determine the minimum acceptable volume. In Part 2, participants (n = 16) assessed pimavanserin 34 mg mixed with the minimum volume of food vehicle determined in Part 1. EOT = end of treatment.
Figure 2
Figure 2
Assessments of (A) palatability and (B) swallowability of pimavanserin/food vehicle mixtures. Mean (SD) participant assessments (n = 18) of pimavanserin 34 mg mixed with 15 mL of indicated food vehicle. SD = standard deviation.
Figure 3
Figure 3
Secondary endpoint assessments of (A) mouthfeel, (B) smell, (C) bitterness, and (D) aftertaste of pimavanserin/food vehicle mixtures. Data shown are the mean (SD) of participant assessments (n = 18) of pimavanserin 34 mg mixed with 15 mL of indicated food vehicle. SD = standard deviation.
Figure 3
Figure 3
Secondary endpoint assessments of (A) mouthfeel, (B) smell, (C) bitterness, and (D) aftertaste of pimavanserin/food vehicle mixtures. Data shown are the mean (SD) of participant assessments (n = 18) of pimavanserin 34 mg mixed with 15 mL of indicated food vehicle. SD = standard deviation.
Figure 4
Figure 4
Assessment of ease of pimavanserin capsule manipulation. Data shown are the mean (SD) of participant assessments (n = 16) of ease of capsule manipulation, defined as opening and emptying capsule contents. SD = standard deviation.
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