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FDA Approves First New Motion Sickness Drug in 40 Years

Millions of Americans will soon benefit from a groundbreaking oral medication designed to alleviate motion sickness, as the US Food and Drug Administration (FDA) has approved Tradipitant, branded as Nereus. This marks the first new treatment for motion-induced vomiting in over 40 years, providing a modern solution to a common travel issue.

Tradipitant is classified as a neurokinin-1 (NK-1) receptor antagonist, developed by Vanda Pharmaceuticals. According to Mihael Polymeropoulos, CEO of Vanda, this approval offers patients access to a novel therapy that employs contemporary neuropharmacological principles. The medication aims to prevent motion sickness without the limitations associated with traditional treatments, which have included antihistamines known to cause side effects like drowsiness.

Motion sickness affects up to 30% of adults, making travel uncomfortable and often distressing. Traditional remedies have remained largely unchanged, with limited effectiveness. Nereus operates by blocking the NK-1 receptor in the brainstem, which is involved in the vomiting reflex triggered by the neurotransmitter substance P. By inhibiting this pathway, the drug effectively reduces the occurrence of motion-induced vomiting.

The FDA’s decision was informed by three clinical trials. Two of these were Phase III studies conducted in real-world settings, specifically on boats, demonstrating Nereus’s ability to significantly decrease vomiting compared to a placebo. This strong evidence of efficacy played a critical role in the FDA’s approval process.

As safety concerns were raised regarding long-term use, Vanda Pharmaceuticals and the FDA noted that motion sickness is typically an acute condition. Therefore, the medication is not intended for extended use. Nereus is anticipated to be available at pharmacies within months.

In addition to its primary indication, Nereus will undergo further investigation to evaluate its potential for treating other conditions, such as gastroparesis and nausea associated with weight-loss medications. The results from the clinical trials are published in the journal Frontiers in Neurology, reflecting a significant milestone in the field of motion sickness treatment.

With the approval of Nereus, many can look forward to a more pleasant travel experience, free from the discomfort of motion sickness.

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