Scopolamine nasal spray in motion sickness:: a randomised, controlled, and crossover study for the comparison of two scopolamine nasal sprays with oral dimenhydrinate and placebo

Scopolamine has been used successfully for treatment of motion sickness for almost a century and the nasal administration was first studied 50 years ago. However, there never appeared a nasal dosage form. Finally. after finding a stable and suitable formulation for scopolamine. a study to investigate efficacy, safety, and tolerability was conducted, with a randomised, double-blind, double-dummy, crossover, Latin square design including placebo control and a placebo/placebo control for internal validity at the German Air Force Institute of Aviation Medicine. To assess the efficacy of a new, stable and well-tolerated formulation of scopolamine nasal spray the reproducible induction of whole body vibrations by a rotating chair was chosen and a validated seasickness score (SKS). The reduction of SKS showed that scopolamine nasal spray at a concentration of 0.2% was statistically superior to both placebo and dimenhydrinate (P=0.003 and 0.004. respectively). There were no signs for a nasal or epipharyngeal irritation of the mucous membrane. Scopolamine nasal spray was found to be an effective and safe treatment in motion sickness, with a fast onset of action within 30 min after administration. (C) 2001 Elsevier Science B.V. All rights reserved.