Historic Breakthrough Achieves Major Progress in Preventing Motion Sickness

Vanda Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for NEREUS (tradipitant), a groundbreaking treatment aimed at preventing motion sickness. This development marks the first new pharmacologic option for this condition in over forty years.

Significance of NEREUS Approval

The approval of NEREUS represents a major leap forward in treating motion sickness, a common yet debilitating condition affecting approximately 25–30% of adults in the U.S. This translates to around 65–78 million individuals experiencing symptoms when traveling by car, plane, or boat.

A Response to a Long-Standing Need

Motion sickness has been a recognized issue since World War II. During the D-Day invasion in 1944, many troops suffered severe seasickness, which hindered their operation. Today, motion sickness continues to impact the military and civilians alike, often disrupting travel and daily activities.

Clinical Evidence Supporting NEREUS

Vanda Pharmaceuticals conducted three pivotal clinical trials, demonstrating the efficacy of NEREUS compared to a placebo. Key findings include:

• Motion Syros Study: Involving 365 participants, the vomiting incidence was 18.3–19.5% with NEREUS versus 44.3% with placebo.
• Motion Serifos Study: Involving 316 participants, the vomiting rates were 10.4–18.3% with NEREUS compared to 37.7% with placebo.

Both studies showed a significant reduction in vomiting, with risk reductions exceeding 50–70%.

Mechanism of Action

NEREUS functions as a neurokinin-1 (NK-1) receptor antagonist. By blocking substance P, it directly targets the pathways responsible for nausea and vomiting. This mechanism offers a new approach to managing symptoms effectively, providing a solution for those inadequately served by traditional therapies.

Future Directions

Looking ahead, Vanda Pharmaceuticals plans to launch NEREUS in the coming months. The company is also exploring additional applications of tradipitant, targeting conditions like gastroparesis and nausea from GLP-1 receptor agonists.

Conclusion

The approval of NEREUS is a significant milestone in motion sickness treatment. With its modern neuropharmacological basis, it promises effective prevention for millions affected by this condition.