Vanda Pharmaceuticals announced that it has received a complete response letter from the FDA for its potential treatment for jet lag.
The drug, Hetlioz, has already been approved to treat non-24-hour sleep-wake disorder, which disrupts the circadian rhythms that regulate normal sleeping patterns. Vanda submitted its application for Hetlioz as a treatment for jet lag disorder based on trials showing that people slept for nearly three hours longer for three nights following a transatlantic flight when taking the drug than they did without it.
But the FDA said there was not enough information to prove there is a clinical benefit to the treatment.
Vanda reported in a press release that it is “perplexed” by the agency’s conclusion. But the company said it will continue working with the FDA to gain marketing approval for Hetlioz as a jet lag treatment, which the company said is currently an unmet medical need.
Read the press release.