Vanda Pharmaceuticals’ quest to get sleep med Hetlioz approved for more indications has hit a snag. The drugmaker received a Complete Response Letter (CRL) from the FDA taking issue with the way Vanda demonstrated improved sleep in a small study of people who flew from the U.S. to the U.K.
Vanda reported data from that study in May 2018. It looked at 25 patients who flew from Washington D.C., San Francisco or Los Angeles to London and stayed there for three or four days. Though the study’s goal was to compare the melatonin receptor agonist to placebo in 90 patients, it stopped enrolling at 25 “due to the complexity of the study,” the company said.
The 13 patients treated with Hetlioz slept nearly three hours longer than the 12 on placebo, Vanda reported. But the FDA was unimpressed.
“In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance,” Vanda wrote in a statement Monday.
As for Vanda? The company is “perplexed.” It cited the millions of travelers that experience jet lag every year, emphasizing that these people often use “unapproved remedies, which do not address either the symptoms or the underlying cause of the disorder, and often come with potentially dangerous side effects.” These may include over-the-counter sleep aids or melatonin.
This isn’t the first time the FDA has flagged issues with the supplemental NDA for Hetlioz. Last month, Vanda revealed that the agency had “identified deficiencies” in the application that “preclude discussion of labeling and postmarketing requirements/commitments at this time.” The FDA didn’t specify what those deficiencies were, but it did say the note did not mean it was rejecting the application.
That isn’t the case now.
"We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program," said Vanda CEO Mihael Polymeropoulos, M.D., in the statement. "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."
Hetlioz scored FDA approval for non-24-hour sleep/wake disorder in 2014, and Vanda has been working to get it approved in more indications. Behind its jet lag program, it is testing Hetlioz in delayed sleep phase disorder, pediatric non-24 and the developmental disorder Smith-Magenis syndrome.