Vanda Pharmaceuticals surges as FDA approves motion sickness drug

(Sharecast News) - Vanda Pharmaceuticals shares rocketed on Wednesday after the US Food and Drug Administration approved its motion sickness drug.

The approval - for Nereus (tradipitant) - marks the first new pharmacologic treatment in motion sickness in more than four decades. Vanda said it represents "a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognised as a factor affecting military operational readiness".

The efficacy of the drug is supported by "robust" data from three pivotal clinical trials, Vanda said. There were two Phase 3 real-world provocation studies conducted on boats and one additional supporting study with participants who had documented histories of motion sickness.

Mihael H. Polymeropoulos, M.D., president, chief executive and chairman of the board of Vanda Pharmaceuticals, said: "This approval underscores the strong scientific evidence in the antiemetic effects of Nereus in motion sickness.

"For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology, offering effective prevention without the limitations of existing options. We are proud of this historic milestone and grateful to the Vanda researchers, patients, investigators, and regulators who contributed to this achievement."

At 1235 GMT, the shares were up 21% in pre-market trade at $8.51.