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Jet lag drug application declined by US Food and Drug Administration

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A drug that purports to cure many of jet lag has been delayed much like your flight.

Vanda Pharmaceuticals, the Washington, DC-based firm behind Hetlioz, a new drug that may be able to help fight the sleep problems that come with intercontinental travel, said Monday that it received notice from the US Food and Drug Administration on Friday that its application for the medicine had not been approved.

“Vanda is perplexed by this conclusion,” it said in a press release, “given that millions of travelers who experience JLD every year recognize that JLD is characterized by disruption of nighttime sleep and/or sleepiness during the day due to rapid travel across time zones.”

According to the company, patients reported “sleeping nearly three hours longer” for the three nights after a transatlantic trip after taking to the drug. But its letter to Vanda, the FDA said the drug’s results thus far have been “of unclear clinical significance,” according to Vanda’s press release.

There aren’t any currently approved drugs that specifically target jet lag, leading travelers to rely on treatments like both over-the-counter and prescription sleeping pills, as well as things like light therapy, according to Mayo Clinic.

Read more: The one thing you should do before boarding a plane to avoid jet lag, according to a sleep specialist

Vanda says it plans to keep working with federal regulators to get the treatment approved, but don’t get too excited just yet. Even if the drug gets the government green light, it could cost up to $1,500 for a three-day dosage, analysts estimate.

“Given Hetlioz’s orphan pricing in Non-24, we had estimated the cost for 3 days of therapy for JLD would have been approximately ~$1,500, much higher than OTC and/or Rx sleep products which are typically used,” Derek Archila, an analyst at Stifel, told clients in a note Monday.

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