Prime Highlights:
- FDA approves NEREUS™ (tradipitant), a new oral treatment to prevent vomiting caused by motion sickness.
- This marks the first new medication for motion sickness in over four decades, offering hope for millions affected.
Key Facts:
- Motion sickness affects 25–30% of adults in the U.S., with some experiencing severe, recurring symptoms that disrupt daily life and travel.
- NEREUS™ works by blocking NK-1 receptors in the brain, directly targeting the biological cause of nausea and vomiting.
Background:
Vanda Pharmaceuticals got FDA approval for NEREUS™, the first new motion sickness pill in over 40 years.
NEREUS™ works by blocking signals in the brain that cause nausea and vomiting. Current treatments don’t always work well and can make people sleepy, so this new option is an important improvement.
“This approval reflects the strength of the clinical evidence supporting NEREUS™ and represents a historic milestone for patients,” said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of Vanda Pharmaceuticals. “For the first time in over 40 years, motion sickness sufferers have access to a therapy based on modern neuropharmacology that offers effective prevention without the limitations of current treatments.”
The FDA decision was supported by data from three pivotal clinical studies, including two Phase 3 real-world trials conducted in maritime settings. In the Motion Syros study involving 365 participants, vomiting rates were reduced to 18.3–19.5% with NEREUS™, compared with 44.3% in the placebo group. In the Motion Serifos trial (316 participants), vomiting occurred in 10–18% of people taking NEREUS™ compared to 37.7% with placebo, showing it cuts the risk by more than half. The drug was also safe for short-term use.
Motion sickness is more than just a minor problem. It has affected military operations, including during World War II, and still affects both civilians and the military today. In the U.S., 25–30% of adults experience motion sickness while traveling, and some have severe symptoms that disrupt daily life.
Vanda will launch NEREUS™ soon. The company is also testing tradipitant for gastroparesis and nausea caused by some diabetes and weight-loss medicines.
With this approval, NEREUS™ provides a new way to prevent motion sickness and could be used for other related conditions in the future.
