Tradipitant Prevents Vomiting in Individuals with Motion Sickness, claims Phase III study
Vanda Pharmaceuticals Inc. announced strong results from its second Phase III study of tradipitant for motion sickness which confirms the previous findings of the drug’s efficacy in preventing vomiting associated with the condition. This pivotal study was conducted in real-world conditions aboard boats in the coastal waters of the US which added significant credibility to the results.
The multicenter, randomized, double-blind, placebo-controlled trial involved 316 participants. These participants had a history of motion sickness and embarked on 20 boat trips under various sea conditions between September 2023 and April 2024. The study evaluated the effectiveness of two doses of tradipitant, 170 mg and 85 mg against a placebo. The primary endpoint of the study was the prevention of vomiting with the 170 mg dose of tradipitant. Secondary endpoints included the effectiveness of the 85 mg dose and the prevention of severe nausea and vomiting for both doses.
The results were highly favorable for tradipitant where only 10.4% of participants on the 170 mg dose and 18.3% on the 85 mg dose underwent vomiting when compared to 37.7% in the placebo group. These findings represent a significant reduction in the risk of vomiting which was over 70% for the 170 mg dose and over 50% for the 85 mg dose (p=0.000002 and p=0.0014, respectively).
Tradipitant also demonstrated significant efficacy in preventing severe nausea and vomiting. When data from both doses were combined, only 13.3% of the participants reported severe symptoms versus 33.0% in the placebo group (p=0.00003). Motion sickness is a common issue with limited effective treatments. The U.S. Food and Drug Administration (FDA) has not approved a new medication for motion sickness in over 40 years, the last being scopolamine in 1979. Existing treatments often suffer from low efficacy or significant side effects.
Vanda Pharmaceuticals plans to submit a New Drug Application (NDA) for tradipitant to the FDA in the fourth quarter of 2024 by hoping to address this longstanding unmet need. The Motion Serifos study provided strong evidence for the efficacy of tradipitant in preventing vomiting and severe nausea associated with motion sickness. The participants who took the higher 170 mg dose of tradipitant had a notable lower incidence of vomiting when compared to the individuals on a placebo with a risk reduction of over 70%. Also, the 85 mg dose also showed a significant reduction in vomiting incidence by over 50% when compared to placebo. In conclusion, the combined analysis of both doses showed a substantial reduction in severe nausea and vomiting which indicates the potential of tradipitant as a comprehensive treatment for motion sickness symptoms.
Source:
Vanda Pharmaceuticals Inc. (2024, May 15). Vanda pharmaceuticals reports positive results from a second Phase III study of tradipitant in motion sickness. PR Newswire. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-positive-results-from-a-second-phase-iii-study-of-tradipitant-in-motion-sickness-302146315.html
