Vanda Pharmaceuticals Reports Positive Phase III Results for HETLIOZ

The study, which enrolled 43 patients across 26 clinical sites, met its primary endpoint by demonstrating a 37.1-minute improvement in sleep onset timing compared to a placebo. Participants receiving 20 mg of the drug saw their sleep cycles shift by an average of 42.5 minutes, while the placebo group experienced a minor shift of only 5.4 minutes. Beyond the primary metrics, an exploratory analysis indicated that 60% of those treated with the medication achieved a sleep advancement of at least 30 minutes, a threshold reached by only 15% of the control group.

DSWPD is a persistent body-clock disorder, distinct from common sleep preferences, that prevents individuals from falling asleep until the early morning hours. With no current FDA-approved treatments, the condition often leaves patients struggling to maintain standard work or family schedules. Vanda plans to submit a supplemental New Drug Application to the FDA, leveraging over a decade of clinical data from the drug's existing use in treating Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome. According to Mihael H. Polymeropoulos, CEO of Vanda, the company aims to establish the drug as a versatile tool for regulating circadian rhythms.