Vanda Pharmaceuticals Inc. (VNDA) on Tuesday shared topline results from a pivotal Phase 3 trial evaluating HETLIOZ (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD).

The company plans to present these results to the U.S. Food and Drug Administration and submit a supplemental New Drug Application seeking full regulatory approval.

If approved, HETLIOZ will become the first FDA-cleared medication designated for this specific circadian body-clock condition.

Phase 3 Results for Sleep Treatment

The U.S. FDA initially cleared HETLIOZ as a circadian regulator in 2014 to treat Non-24-Hour Sleep-Wake Disorder in adults.

Regulators expanded approval in 2020 to treat nighttime sleep disturbances associated with Smith-Magenis Syndrome.

The current clinical development program seeks to extend the identical 20 mg daily formulation to address a third distinct circadian sleep-wake indication.

Understanding Delayed Sleep-Wake Phase Disorder

DSWPD is a circadian rhythm condition where the internal body clock is delayed by two hours or more past normal or desired sleep times.

As a result, patients face significant difficulties waking for routine employment, educational, or family commitments.

The disorder impacts approximately 0.5 million to 4.1 million American adults, or 0.2% to 1.5% of the adult population, and frequently presents alongside common psychiatric conditions.

The Phase 3 trial evaluated adult patients aged 18 to 75 with confirmed diagnoses over a five-year period.

Researchers evaluated more than 260 individuals and enrolled 43 patients, administering daily oral tasimelteon 20 mg or placebo over 28 days.

Primary Trial Endpoints

The study met its primary endpoint, with HETLIOZ advancing sleep onset by 42.5 minutes compared to a 5.4-minute shift for placebo, representing a statistically significant 37.1-minute difference. Sleep diaries recorded these onset timings.

Furthermore, an exploratory responder analysis showed that 60% of tasimelteon participants advanced sleep timing by at least 30 minutes, compared to 15% on placebo.

Vanda intends to include these results along with prior clinical trials and over ten years of commercial use in its regulatory filing.

VNDA Price Action: Vanda Pharmaceuticals shares were up 3.98% at $5.23 during premarket trading on Wednesday, according to market data.