Vanda says Phase III trial shows HETLIOZ advances sleep onset in delayed sleep-wake phase disorder
VNDA•Vanda reported positive topline Phase III results showing patients taking HETLIOZ were more likely than placebo patients to shift sleep earlier; it plans to discuss the data with the FDA before filing a supplemental NDA.
1. Trial results and next steps
Vanda said safety during the controlled treatment period was consistent with HETLIOZ’s existing label, with no new safety issues flagged. If approved for the new indication, HETLIOZ would be the first FDA-indicated drug for delayed sleep-wake phase disorder.
