How Do You Test a New Seasickness Drug? Take Pill, Set Sail

(Bloomberg) -- Most drug trials take place in sterile hospital labs, universities or clinics. Vanda Pharmaceuticals Inc. decided a boat in the Pacific Ocean would be better.

It wasn’t for relaxation; actually quite the opposite. Vanda wanted to try to make the participants in the trial seasick.

Vanda, a small biopharmaceutical company based in Washington, has completed the second phase of clinical trials of a motion-sickness drug it hopes will compete with industry leader Dramamine. In a double-blind test, the company sent 126 participants with a prior history of motion sickness on ships off the coast of Los Angeles, with some receiving the company’s motion-sickness drug tradipitant and others getting a placebo.

The study yielded strong results overall, Vanda said, with 40% of placebo recipients vomiting, compared with only 17.5% for those who had taken tradipitant. In rough sea conditions, the new drug fared even better, with more than 72% of the placebo group vomiting, compared with almost 16% for those treated with tradipitant.

Motion sickness, which Vanda said affects about 30% of travelers, is believed to be caused by a mismatch between the motion one sees and the movement one feels. About 2 million to 3 million doses of Prestige Consumer Healthcare Inc.’s Dramamine are purchased each month in the U.S., according to data from Iqvia cited by Vanda. That’s only a fraction of the number of people treated for motion sickness each month, Vanda said.

Vanda’s participants, divided over seven trips between January and May, were loaded onto a double-deck ferry boat, said Vasilios Polymeropoulos, director of medical analytics for Vanda. Researchers elected to use a single-hull boat for more variability because catamarans, which have two hulls, are considered to be more stable.

“Once the people were on the boat, they were driven on a specified route in the ocean, similar to a regular excursion in the ocean, and at 30-minute intervals they completed questionnaires to access their symptoms of motion sickness,” Polymeropoulos said. The results were measured by a severity scale ranging from 0 for no symptoms to 6 for vomiting.

Choppy Seas

Participants faced calm or rough sea conditions. The patients facing waves higher than 1 meter (3.3 feet) may not have been so fortunate, but Polymeropoulos said it allowed researchers to see how the medication worked in different weather conditions.

The researchers had to get their sea legs as well. While Polymeropoulos wasn’t present on the seven trips, he was on the boat during the design process. The researchers had to speak to nautical experts to learn more about how ships are affected by movement.

Health-care observers on Twitter like Brian Skorney, an analyst at Robert W. Baird & Co., were fascinated by the study’s design. Many asked questions about what it might have been like for people participating in the trial.

“I’m sure we’re all in our mind making it out to be much more exciting than it probably is, but it’s just interesting,” Skorney said. “It’s just so different than what I’m used to looking at as clinical data.”

It wasn’t the first time subjects have been taken on boats for a study on motion sickness. Seasickness medications were developed and tested for military personnel around World War II.

But a more recent study, which Polymeropoulos said was the model for Vanda’s, dates to 1980. Researchers tested transdermal scopolamine, a patch for motion sickness, by taking participants on yachts in the Pacific.

“That was really the guiding study because since then, there have been no other medications approved for motion sickness,” Polymeropoulos said.

There’s no guarantee that Vanda is going out to sea again any time soon, but the company is working on a third-phase test for the drug. It plans to file for market approval in 2020.

To contact the reporter on this story: Myah Ward in New York at mward174@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet, Timothy Annett

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