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16h ago

FDA Approves Vanda’s Nereus, First New Drug for Motion-Induced Vomiting in Over 40 Years

The decision followed a reclassification of motion sickness to an acute condition that lifted a longstanding clinical hold.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
Up to 78 million adults in the US are estimated to be affected by motion sickness. RealPeopleStudio via Shutterstock.com.
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Overview

  • The approval covers prevention of motion-induced vomiting in adults, with Vanda planning a U.S. launch in the coming months.
  • Regulators based the decision on two late-stage studies totaling 681 participants that showed statistically significant reductions in vomiting versus placebo.
  • Vanda-reported data showed vomiting in 18%–20% of Nereus patients versus 44% on placebo in one trial, and 10%–18% versus 37.7% in another.
  • Nereus is an oral neurokinin-1 receptor antagonist that targets a pathway implicated in nausea and vomiting, with common adverse reactions including somnolence (6%–12%) and fatigue (6%–8%).
  • The FDA lifted a partial clinical hold on Dec. 4 after classifying motion sickness as acute and dropping six-month dog toxicity studies, and Vanda shares rose about 20% after hours on the approval.