Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced the publication of new clinical data in PLOS ONE demonstrating that its melatonin receptor agonist HETLIOZ® (tasimelteon) significantly improved sleep outcomes in patients with primary insomnia.
Study Highlights
The multicenter, randomized, double-blind, placebo-controlled trial met its primary endpoint:
- Latency to Persistent Sleep (LPS): Mean improvements of 44.9 minutes (20 mg) and 46.3 minutes (50 mg) versus 28.2 minutes (placebo) (p < 0.001).
- Durability: Improvements persisted through Nights 22 and 29 (p < 0.01).
- Safety: No cognitive or mood changes, and no rebound or withdrawal effects after discontinuation.
Addressing a Major Health Burden
Insomnia affects over 10% of Americans and is linked to impaired daily functioning and significant morbidity.
“HETLIOZ® is already FDA-approved for Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome–related sleep disturbances. These data strengthen its potential in insomnia and other circadian-related conditions where unmet need remains high.”
- Vanda spokesperson.
Expanding Development Path
Vanda is pursuing FDA approval for HETLIOZ® in insomnia and Jet Lag Disorder, while also advancing development in Delayed Sleep Phase Disorder (DSPD) and pediatric insomnia.
About HETLIOZ®
HETLIOZ® is a melatonin receptor agonist and circadian regulator. It is FDA-approved for:
- Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
- Nighttime sleep disturbances in adults and children with Smith-Magenis Syndrome
For full U.S. Prescribing Information,
About Vanda Pharmaceuticals
Vanda Pharmaceuticals Inc. is a global biopharmaceutical company developing and commercializing innovative therapies for high unmet medical needs.
