19 August 2019 - Vanda Pharmaceuticals today announced that on 16 August 2019, it received a complete response letter from the U.S. FDA as part of its ongoing review of Vanda's supplemental new drug application for Hetlioz (tasimelteon) for the treatment of jet lag disorder.

As Vanda previously reported on 23 May 2018, jet lag disorder patients reported sleeping nearly three hours longer over the three nights following their transatlantic trip when treated with Hetlioz than they did over the three nights following their untreated transatlantic trip, consistent with Vanda's jet lag simulation studies. 

In the letter, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.

Read Vanda Pharmaceuticals press release