Accession Number:

AD1039811

Title:

The Pharmacokinetics and Efficacy of a Low-dose, Aqueous, Intranasal Scopolamine Spray

Descriptive Note:

Technical Report,01 Jul 2013,30 Apr 2017

Corporate Author:

Naval Medical Research Unit - Dayton Wright-Patterson Air Force Base United States

Personal Author(s):

• Geyer,Daniel J.
• Gomez,Jacqueline
• Littman,Eric M
• Becker,William J
• Doubrava,Matthew R

Report Date:

2017-09-27

Pagination or Media Count:

42.0

Abstract:

The study examined both the pharmacokinetic properties and efficacy of a low-dose, aqueous, intranasal scopolamine spray INSCOP as an anti-motion sickness prophylaxis. The study was divided into two phases a pharmacokinetics PK phase, which established pharmacokinetic parameters, and an Efficacy phase, which was a within-subjects, cross-over, double blind, placebo controlled trial testing the efficacy of INSCOP during mechanical rotation. Cognitive testing, blood samples, subjective alertness, and adverse events were collected in both parts. INSCOP is rapidly absorbed, having detectable plasma levels in 10 to 15 minutes for most subjects, and reaching maximum plasma concentrations typically within 60 minutes. Measured by the number of head tilts tolerated during mechanical rotation, subjects receiving INSCOP tolerate an average of 31 head tilts more when using INSCOP compared to a placebo condition. Cognitive assessments and subjective fatigue measurements were not significantly different between conditions. INSCOPs positive efficacy and safety profile having been identified, future studies can address multi-dose schedules and operational field trials.

Descriptors:

• motion sickness
• therapeutics
• military operations
• pilot studies
• military personnel
• sprays
• PHARMACOKINETICS
• medicine

Subject Categories:

• Medicine and Medical Research
• Stress Physiology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE