A total of 83 patients we're enrolled in the first phase of a two-phase study evaluating intranasal scopolamine versus placebo impatience greater than 55 years of age. 80 of these patients plus an additional 18 patients were recruited and continued into a second phase of pharmacokinetic and safety evaluation. The first phase of the study was one day at sea. The second phase was three days in a laboratory setting. In the first phase of the study, intranasal scopolamine was efficacious in preventing vomiting and/or the need for rescue medication. In the first phase of the study, there were no SAE’s nor any adverse events of severe intensity. In the open label second phase of the study, all patients received intranasal scopolamine and all AE’s reported were mild. In the pharmacokinetic phase of the study, the T Max was between 56 to 60 minutes across all doses and there was no accumulation of scopolamine concentrations with twice daily dosing.
2. Reader can assess efficacy of intranasal administration of scopolamine for treatment of vomiting and need for rescue medication in the geriatric population.
3. Reader can assess the pharmacokinetics of intranasal scopolamine over three days administration in a geriatric population