Investing.com -- Vanda Pharmaceuticals (NASDAQ:VNDA) stock rose 11% in after-hours trading on Thursday after the company announced that the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on its tradipitant protocol for motion sickness treatment.
The FDA’s decision removes previous limitations that restricted the protocol VP-VLY-686-3403 to a maximum of 90 doses of tradipitant. The agency agreed with Vanda’s position that motion sickness represents an acute, self-limiting physiologic response rather than a chronic condition, eliminating the need for an additional six-month dog toxicity study.
This regulatory development allows Vanda to extend clinical studies of tradipitant in motion sickness. The resolution followed Vanda’s formal dispute resolution request and an expedited re-review conducted by FDA leadership under a collaborative framework established between the company and the agency in October 2025.
Separately, Vanda confirmed that the review of its New Drug Application for tradipitant for the prevention of motion-induced vomiting remains on track with a PDUFA target action date of December 30, 2025. If approved, tradipitant would be the first new pharmacologic treatment for motion sickness in over 40 years.
Mihael H. Polymeropoulos, President and CEO of Vanda, stated that "The swift and favorable resolution of this issue highlights the effectiveness of our collaborative framework with the FDA."
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