Vanda ends 40-year hiatus for new motion sickness drugs

The FDA's usual end-of-year flurry of regulatory approvals is a little lighter than usual, but the agency has delivered some end-of-year cheer to Vanda Pharma after giving the go-ahead to its drug for motion sickness.

The US regulator cleared Nereus (tradipitant) for the prevention of vomiting induced by motion, becoming the first new pharmacologic treatment for the condition in around four decades.

The decision comes 15 months after the agency declined to approve tradipitant for delayed gastric emptying (gastroparesis), an indication for which it is still being developed along with the prevention of nausea and vomiting associated with GLP-1 agonist drugs used to treat diabetes and weight loss.

It also comes just a few weeks after the FDA lifted a partial clinical hold on the oral neurokinin-1 (NK-1) receptor antagonist after agreeing that its potential use as an acute treatment for motion sickness meant there was no need for a six-month toxicity study, clearing the way for a clinical trial that could extend its label in future.

In a statement, Vanda said the approval marks "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 company estimates that between 25% and 30% of adults – roughly 65–78 million people in the US – experience sickness symptoms whilst travelling in cars, planes, boats, and other modes of transport.

While most cases are mild, up to 15% of the population experiences severe, recurrent symptoms that can significantly impact quality of life, according to Vanda. It sees potential for Nereus in people who don't get sufficient relief using current therapies and those who avoid travel because they are so severely affected by symptoms. Analysts have suggested sales of Nereus could reach $100 million a year in the US.

The approval is based on two late-stage studies with a total of 681 patients exposed to motion on boats, in which the preventative use of tradipitant was associated with significantly reduced vomiting.

The approval gives Vanda an opportunity to accelerate sales growth, currently being driven by Fanapt (iloperidone) for schizophrenia and manic or mixed episodes associated with bipolar I disorder, Hetlioz (tasimelteon) for sleep disorders, and Ponvory (ponesimod) for multiple sclerosis, which collectively brought in $56 million in third-quarter sales.

Hetlioz is also under review for jet lag disorder, a use that was rejected by the FDA in 2019. Earlier this year, a lawsuit filed by the company forced the regulator to reconsider its application, with a new decision now due by 7th January.

Image by Dorothe Wouters from Pixabay