The purpose of this study (DPI-386-MS-33) is to prospectively evaluate the difference in the rate of complete response, defined as no vomiting and no rescue treatment (e.g., antihistamine) within the 4-hour period after study drug administration, or to the end of the voyage, whichever comes later, between 0.2 mg scopolamine administered as the DPI-386 Nasal Gel and Placebo Nasal Gel to subjects ≥18 years of age (inclusive) with a history of symptoms consistent with motion sickness (MS). The sample size of 250 subjects per treatment arm is considered sufficient to demonstrate a statistically significant difference between treatments.
This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating DPI-386 Nasal Gel versus placebo. Approximately 500 subjects will be randomized 1:1 (250 DPI 386 Nasal Gel/250 matching Placebo Nasal Gel) are planned to be enrolled.