Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

WASHINGTON, Feb. 5, 2024 -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. In a letter to Vanda dated July 17, 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation. A Phase III, multi-center, placebo-controlled, 4-week trial evaluated patients with chronic primary insomnia. Two transient insomnia studies induced by phase advance of the sleep-wake cycle were also conducted with five-hour and eight-hour phase advance, which showed a significant effect the first night in improving sleep parameters... Vanda Pharmaceuticals' Press Release [PDF] - 

Vanda Pharmaceuticals : Phase III Clinical Study Aimed at Resetting the Body Clock

Aug 26, 2010 - Study to Evaluate Effect on Sleep/Wake Cycle in Blind Individuals with Non-24-Hour Sleep Wake Disorder - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), announced it has initiated a Phase III clinical trial to evaluate tasimelteon in patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. Tasimelteon binds to high affinity melatonin receptors located in the brain that are believed to regulate circadian rhythms, or sleep/wake cycles.

"Blind individuals with no light perception do not receive external light and darkness signals that synchronize our internal body clocks... Vanda Pharmaceuticals' Press Release -

Vanda Pharmaceuticals : Phase III Data Show Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia

June 26, 2008 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) (Vanda) announced positive top-line results from a Phase III trial showing that its investigational drug candidate, tasimelteon (VEC-162), a novel melatonin agonist, met the primary endpoint of the trial and significantly improved sleep in adult patients with chronic insomnia.

We are excited that the results of this Phase III chronic insomnia study demonstrate the clinical utility of tasimelteon and the ability of the compound to treat sleep disorders over a period of four weeks. The mechanism of action of tasimelteon as a circadian regulator gives Vanda the opportunity to explore its use for the treatment of circadian rhythm sleep disorders as well as chronic primary insomnia... Vanda Pharmaceuticals' Press Release -