The U.S. FDA has lifted the partial clinical hold on protocol VP-VLY-686-3403 for tradipitant, allowing for extended clinical studies in motion sickness.
Vanda Pharmaceuticals successfully resolved the issue through a formal dispute resolution request and collaborative efforts with the FDA.
The decision positions tradipitant as a potentially groundbreaking treatment for motion sickness after over 40 years.
FDA Lifts Clinical Hold
FDA lifted the hold on tradipitant in motion sickness studies, enabling further clinical development.
Swift Resolution
The resolution emphasizes the effectiveness of Vanda's collaboration with the FDA in clinical research.
PDUFA Target Date
The New Drug Application for tradipitant is on track with a PDUFA action date set for December 30, 2025.
- The lifting of the clinical hold opens up opportunities for Vanda to advance the development of tradipitant in motion sickness, potentially revolutionizing treatment options.
- The positive resolution showcases Vanda's commitment to innovation and overcoming regulatory challenges in drug development.
The favorable decision by the FDA marks a significant milestone for Vanda Pharmaceuticals, paving the way for enhanced research and the potential commercialization of tradipitant for motion sickness.