US regulator lifts dosing cap on tradipitant studies for motion sickness

US biotech Vanda Pharmaceuticals (Nasdaq: VNDA) has announced that the American medicines regulator removed a partial clinical hold on tradipitant, clearing a long-standing dosing cap that had restricted its motion sickness protocol to 90 administrations. The move followed a formal dispute process and an expedited re-review by senior agency staff.

The decision reflects the US Food and Drug Administration’s agreement that motion sickness is an acute, event-driven condition, not a chronic disorder, eliminating the need for a six-month dog toxicity study.

Vanda said the outcome lets it extend clinical testing as the agency continues to evaluate a completed filing for the prevention of motion-induced vomiting, due for action on December 30.