Vanda Pharmaceuticals Reports Positive Phase III Trial Results for HETLIOZ®

Vanda Pharmaceuticals (Nasdaq: VNDA) has announced positive topline results from its pivotal Phase III study of HETLIOZ® (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD). The company plans to discuss these data with the U.S. Food and Drug Administration (FDA) and submit a supplemental New Drug Application (sNDA) seeking approval for HETLIOZ® for DSWPD.

The study met its primary endpoint, with HETLIOZ® shifting the onset of sleep an average of 37.1 minutes earlier compared to placebo. In an exploratory analysis, 60% of participants treated with HETLIOZ® advanced their sleep onset by at least 30 minutes, compared to only 15% in the placebo arm.

DSWPD is a circadian rhythm disorder estimated to affect 0.2% to 1.5% of the adult population. If approved for DSWPD, HETLIOZ® would become the first FDA-approved medicine indicated for this condition. The drug is already approved for two other circadian sleep-wake disorders.

The company plans to file the sNDA for HETLIOZ® in DSWPD, which will include this Phase III study along with Vanda's prior studies in related disorders.