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15h ago

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

The approval follows late-stage trials showing significant reductions in vomiting versus placebo.

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
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This drug is expected to be a game-changer for millions who suffer from motion sickness
Up to 78 million adults in the US are estimated to be affected by motion sickness. RealPeopleStudio via Shutterstock.com.

Overview

  • Nereus (tradipitant) is an oral NK‑1 receptor antagonist that targets the substance P pathway implicated in the vomiting reflex.
  • In pivotal studies, vomiting occurred in 18.3%–19.5% of Nereus‑treated patients versus 44.3% with placebo in one trial, and 10.4%–18.3% versus 37.7% in another, including real‑world boat studies.
  • Vanda says it expects to introduce the capsule in the coming months, with reported adverse reactions including somnolence and fatigue in a minority of patients.
  • Vanda’s shares rose about 20% in after‑hours trading following the decision, and B. Riley raised its price target to $14 with a Buy rating.
  • The agency had lifted a 2018 partial clinical hold on Dec. 4 after classifying motion sickness as an acute condition, removing dog study requirements and clearing the development path.