Vanda Pharmaceuticals Inc. announced the results from its second Phase III study of tradipitant in motion sickness, confirming the previously reported results of two efficacy studies demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. This Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States (U.S.). The Motion Serifos study was a multicenter, randomized, double-blind, placebo-controlled study where 316 participants embarked on boat trips under varied sea conditions and received tradipitant 170 mg, tradipitant 85 mg, or placebo. Study participants had a prior history of motion sickness and were distributed across twenty boat trips that took place between September 2023 and April 2024. Sea conditions and participant evaluation of the symptoms of motion sickness were recorded for each trip. The primary endpoint of the study was the effect of tradipitant 170 mg on vomiting. The key secondary endpoints were: (1) the effect of tradipitant 85 mg on vomiting and (2) the effect of tradipitant in preventing severe nausea and vomiting.
Both 170 mg and 85 mg tradipitant doses were shown to be superior to placebo in preventing vomiting with only 10.4% and 18.3% of participants experiencing vomiting on tradipitant 170 mg and 85 mg respectively, as compared to 37.7% of participants on placebo (p=0.000002, p=0.0014) resulting in reduction of risk of vomiting of over 70% in the tradipitant 170 mg group and of over 50% in the tradipitant 85 mg group. Tradipitant (170 mg and 85 mg together) was also effective in the endpoint of prevention of severe nausea and vomiting (tradipitant 13.3%, placebo 33.0%, p=0.00003). Motion sickness remains an unmet need as various pharmacological and non-pharmacological interventions suffer from low efficacy, substantial side effects, or both. The U.S. Food and Drug Administration (FDA) has not approved a new medication for motion sickness in over forty years, since the approval of scopolamine, a transdermal patch placed behind the ear, in 1979. Vanda expects to submit a New Drug Application for tradipitant in the prevention of vomiting induced by motion to the U.S Food and Drug Administration in the fourth quarter of 2024. Motion sickness is a disorder characterized by a constellation of symptoms, with nausea and vomiting being the primary ones. Motion sickness has plagued travelers for thousands of years, as evidenced by the ancient Greek physician Hippocrates who wrote "sailing on the sea proves motion disorders the body". Historians theorize that motion sickness may have changed the fate of civilization on several occasions, notably the defeat of the Spanish Armada by the English in 1588 and the negative effects on Napoleon's camel corps during the Egyptian campaign in 1798. It is believed that a discrepancy between actual body position and perceived body position triggers the maladaptive response of motion sickness. Approximately 30% of the general population is reported to suffer from motion sickness under ordinary travel conditions that include sea, air and land travel. According to IQVIA data, approximately two to three million doses of Dramamine, a common motion sickness remedy, are purchased monthly in the U.S. Dramamine treated patients represent only a fraction of the people treated monthly for motion sickness.
Motion sickness is one of the most prevalent episodic disorders in the world, whose prevalence has dramatically increased with world population mobility over the last 100 years. The U.S. Department of Transportation reports 10 billion trips per year in mass transit (buses and trains), with an additional 965 million passenger trips in domestic and international air travel.