Vanda plans FDA sNDA filing for Hetlioz in delayed sleep-wake phase disorder
VNDA•Vanda reported positive Phase III results for Hetlioz in delayed sleep-wake phase disorder and plans to meet with the FDA and file a supplemental NDA; sleep onset shifted 37.1 minutes earlier than placebo (p=0.022).
1. Phase III results
Vanda reported positive Phase III results for Hetlioz (tasimelteon) in delayed sleep-wake phase disorder. The trial met its primary endpoint, with sleep onset shifting 37.1 minutes earlier versus placebo (p=0.022); Vanda plans to meet with the FDA and file a supplemental NDA seeking a new indication.
