FDA Removes Barrier for Tradipitant Clinical Studies—Major Step Toward New Motion Sickness Therapy

Vanda Pharmaceuticals (NASDAQ: VNDA) made headlines after announcing that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its motion sickness drug, Tradipitant. The decision not only accelerates the development timeline for Tradipitant but could set the stage for the first new FDA-approved therapy for motion sickness in more than four decades.

FDA Endorsement Streamlines Vanda's Pathway for Tradipitant

According to the company's statement, the clinical hold was removed following Vanda's formal dispute resolution request and a quick, high-level review by FDA leadership. Previously, the protocol was capped at 90 doses per subject. With the restriction now eliminated, Vanda can pursue extended clinical studies—bypassing the need for an additional six-month animal toxicity trial, a hurdle that had threatened to delay or derail development.

The FDA agreed with Vanda’s interpretation: motion sickness is an acute condition, not a chronic one. That clarification was key to resolving the impasse, giving Tradipitant a cleaner regulatory path as Vanda prepares for a decision on its New Drug Application (NDA) for motion sickness by December 30, 2025.

PDUFA Decision Could Usher in First New Motion Sickness Drug Since the 1980s

With the clinical hold lifted, attention now shifts to the pending NDA. If approved, Tradipitant could become the first novel pharmacologic solution for motion sickness in over 40 years. For both the company and investors, the next regulatory milestone—the Prescription Drug User Fee Act (PDUFA) action date—is circled on the calendar as a catalyst event.

Management Hails FDA Collaboration—Market Eyes Potential Upside

Vanda’s leadership framed the decision as a validation of its regulatory strategy, emphasizing the productive relationship with the FDA. CEO Dr. Mihael Polymeropoulos highlighted the swift and favorable resolution, expressing optimism about continued progress.

Market participants are now closely watching how the lifted clinical hold and the December PDUFA date could influence VNDA’s profile in both the pharmaceutical industry and among investors searching for event-driven opportunities.

Risks and Next Steps: PDUFA Date and Beyond

While the lifted hold is a win for Vanda, it doesn’t eliminate uncertainty. Approval for Tradipitant still hinges on the FDA’s final assessment of safety and efficacy data by year-end. Any delays or surprises in the review process could impact Vanda’s momentum.

For those following VNDA, the months ahead represent a high-stakes regulatory countdown. Success could revive innovation in a stagnant therapeutic space and position Vanda at the forefront of treating motion sickness with a new class of medicine. Investors may want to keep a close eye on FDA updates as the December 30 PDUFA date approaches.

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