Vanda Pharmaceuticals (VNDA) added ~21% in the premarket on Wednesday after the U.S. FDA approved its motion sickness therapy Nereus (tradipitant), developed in partnership with Eli Lilly (LLY).
Accordingly, the neurokinin-1 (NK-1) receptor antagonist will be available in the U.S. as an oral therapy for the acute prevention of vomiting induced by motion, the company said last night.
The decision is supported by data from three pivotal clinical trials in which Nereus (tradipitant) significantly reduced the incidence of vomiting with a favorable safety profile compatible with acute use, Vanda (VNDA) said.
The approval paves the way for the first new pharmacologic option for motion sickness in more than four decades, a historic milestone for those affected by the condition, which is considered a physiologic response and a factor affecting military preparedness.
Vanda (VNDA), which has licensed tradipitant from Eli Lilly (LLY), plans to launch Nereus in the coming months.