#United States #FDA Approval #Washington #Vanda Pharmaceuticals #Tradipitant

FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness

In a significant advancement for Vanda Pharmaceuticals Inc., the FDA has lifted the partial clinical hold imposed on the company's protocol VP-VLY-686-3403, which had previously restricted the administration of Tradipitant to a maximum of 90 doses. This development, announced on December 4, 2025, stems from a formal dispute resolution request that Vanda submitted, prompting an expedited re-evaluation by the FDA’s Center for Drug Evaluation and Research (CDER).

Context of the Decision

Tradipitant, a neurokinin-1 receptor antagonist developed initially by Eli Lilly, is currently being explored as a potential solution for various conditions, including gastroparesis and nausea induced by GLP-1 receptor agonists. The FDA's previous limitations had information gaps regarding the drug's application for motion sickness, classifying this acute condition in a context that demanded extensive toxicity studies that were considered unnecessary under the new review.

The FDA has now recognized motion sickness as an acute physiological response instead of a chronic disorder, which aligns with Vanda's perspective. This decision eliminates the requirement for an additional six-month dog toxicity study, allowing for a more streamlined progression in clinical studies aimed at motion sickness treatments using Tradipitant.

Implications of the FDA Decision

This pivotal decision clears the way for Vanda to further advance its clinical trials focused on the use of Tradipitant in treating motion sickness. Additionally, a fully completed New Drug Application (NDA) regarding Tradipitant's efficacy in preventing vomiting caused by motion remains under review, with a target action date set for December 30, 2025. If approved, Tradipitant would mark the first innovative pharmacological approach to motion sickness in over four decades.

Dr. Mihael H. Polymeropoulos, President and CEO of Vanda Pharmaceuticals, has emphasized the importance of the FDA’s collaborative approach saying, “The swift and favorable resolution of this issue highlights the effectiveness of our collaborative framework with the FDA.” Vanda has shown gratitude for the agency’s expedited review process and expresses eagerness for ongoing productive dialogues.

About Tradipitant and Vanda Pharmaceuticals

Tradipitant aims to fill critical gaps in the therapeutic landscape for motion sickness, a poorly addressed area for years. The ongoing efforts by Vanda Pharmaceuticals Inc. underline the firm’s commitment to addressing high unmet medical needs through innovative therapies.

Vanda Pharmaceuticals is focused on the commercialization and development of novel solutions to enhance patient efficacy. Interested parties can find more details about their upcoming initiatives and the progress of Tradipitant on their official website at www.vandapharma.com. Vanda is looking forward to potential future collaborations and developments that may arise from this breakthrough in FDA cooperation.

In summary, the FDA's recent decision not only helps streamline the clinical path for Tradipitant but could potentially revolutionize the way motion sickness is treated, offering hope to countless patients suffering from this common affliction. As the deadline for FDA's action approaches, many will be watching closely to see if Tradipitant’s approval becomes a reality, ultimately improving the quality of life for individuals affected by motion sickness.