Name
#157 - Efficacy of DPI-386 Nasal Gel (Scopolamine) Compared to Current Standard of Care (TDS Patch) on Self-Reported Incidents of Gastrointestinal (GI) Adverse Events (AEs) Induced by Motion.
Date & Time
Tuesday, February 13, 2024, 12:00 PM - 7:00 PM
Description

Motion sickness (MS) remains a problem for the military across the Services and in space exploration. The anticholinergic scopolamine is one of the more efficacious anti-motion sickness medications. However, currently available oral and transdermal scopolamine medications have drawbacks compromising utility, including delayed onset of action and dose-related side effects which are significant issues for Warfighters in operational use. The current standard of care is the scopolamine patch (Transderm Scop, TDS Patch) which is indicated for the prevention of nausea and vomiting associated with MS. DPI-386 is a low dose nasal scopolamine gel which was developed in collaboration with the US Navy and NASA. In clinical studies, DPI-386 has demonstrated a rapid onset of action (PK) with a favorable safety profile. MS is a condition characterized by a feeling of unwellness brought on by certain kinds of movement. The usual self-reported GI AEs induced by motion may include: feeling sick to the stomach, feeling queasy, feeling nauseated and feeling like you may vomit. These data presented here focus on the ability of DPI-386 or TDS patch, relative to placebo, to prevent the onset GI AEs. This Phase 3 clinical trial in 300 subjects (100 subjects per arm) compared the efficacy and safety of DPI-386 nasal gel to the TDS patch and placebo in the prevention of self-reported GI AEs. Subjects self-administered six doses of DPI-386 or placebo nasal gel over three days at sea with a minimum of six hours between doses. The TDS patch was placed behind the ear on day one and remained on through day three. Incidence of self-reported GI AEs was significantly lower for DPI-386 Nasal Gel compared to TDS patch or placebo within 4 hours on Day 1 (P-value 0.04), through the end of Day 1 (P-value 0.008), and during the 3-day treatment period (P-value 0.02). With respect to placebo, incidence of self-reported GI AEs was significantly lower for DPI-386 Nasal Gel within 4 hours on Day 1 (P-value 0.006), through the end of Day 1 (P-value 0.006), and during the 3-day treatment period (P-value 0.02). No unexpected adverse events occurred. In conclusion, in this study, self-reported gastrointestinal adverse events associated with the use of DPI-386 when exposed to motion were significantly lower than those self-reported GI AEs induced by motion relative to the TDS patch or placebo.

Location Name
Prince Georges Exhibit Hall A/B
Content Presented on Behalf of
Other entity not listed
Learning Outcomes
1) The audience will gain an understanding of the current routes of administration for the anti-motion sickness agent scopolamine. 2) The audience will learn the difference between GI AEs and other motion-related AEs. 3) The audience will learn about the efficacy and side effects profile of scopolamine administered in a novel dosage form at a lower than conventional dose for prevention of GI AEs.
Session Type
Posters