Intranasal scopolamine (DPI-386) was found to effectively prevent nausea and vomiting induced by motion, according to results from a phase 3 trial.
The double-blind, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT05548270) included approximately 500 individuals 18 years of age and older who were exposed to motion on an ocean voyage.
Study participants were randomly assigned to self-administer scopolamine nasal gel (containing 0.2mg of scopolamine HBr per 0.12g of gel) or placebo. The primary endpoint of the trial was the proportion of participants who reported no vomiting and who did not request rescue treatment (eg, antihistamine).
Findings showed the proportion of patients that met the primary endpoint was significantly greater in the intranasal scopolamine arm compared with the placebo arm (P <.0001). Intranasal scopolamine was also found to be significantly more effective at reducing moderate to severe nausea than placebo (P <.0001). The most common adverse events reported were headache, somnolence (reported more often with intranasal scopolamine than placebo), fatigue, and dizziness.
“The results from this confirmatory pivotal phase 3 trial DPI-386-MS-33 demonstrated that DPI-386 effectively prevents nausea and vomiting induced by motion,” said Barry I. Feinberg, MD, President & CEO of Defender Pharmaceuticals. “This marks an important milestone for Defender and completes all data needed for submission of our NDA.”
Scopolamine is currently approved by the Food and Drug Administration as a transdermal system for the treatment of motion sickness and postoperative nausea and vomiting. According to Defender, scopolamine administered via an intranasal gel demonstrated rapid absorption, which brings the potential benefit of rapid onset of action, based on pharmacokinetic studies.
Defender Pharmaceuticals reports positive results from pivotal phase III clinical trial of intranasal scopolamine for the prevention of nausea and vomiting induced by motion. News release. June 5, 2023. https://www.globenewswire.com/news-release/2023/06/05/2682084/0/en/Defender-Pharmaceuticals-Reports-Positive-Results-from-Pivotal-Phase-III-Clinical-Trial-of-Intranasal-Scopolamine-for-the-Prevention-of-Nausea-and-Vomiting-Induced-by-Motion.html.