To report the FDA approval of NEREUS (tradipitant) for the prevention of motion-induced vomiting in adults.
Approach:
Key Findings:
In Motion Syros (n = 365), vomiting occurred in 18% to 20% of patients receiving tradipitant versus 44% receiving placebo.
In Motion Serifos (n = 316), vomiting rates ranged from 10% to 18% with tradipitant versus 38% with placebo.
Risk reductions of 50% to 70% were observed across studies.
Tradipitant showed a favorable safety profile with common adverse reactions including somnolence and fatigue.
Interpretation:
The approval of tradipitant marks a significant advancement in the treatment of motion sickness, providing a new option for patients who have limited success with existing therapies.
Limitations:
Safety and effectiveness have not been established in pediatric patients.
Use is cautioned in patients with severe renal or hepatic impairment.
Conclusion:
Tradipitant offers a novel therapeutic approach to motion sickness, leveraging modern neuropharmacology to improve patient outcomes.
A single case report described suicidal ideation that resolved after betahistine discontinuation and recurred after rechallenge, but the findings cannot establish causality or quantify risk.
