Vanda announced that the Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) for the treatment of jet lag disorder.
Hetlioz, a melatonin receptor agonist, is currently approved to treat non-24-hour sleep-wake disorder (Non-24). The precise mechanism by which tasimelteon exerts its therapeutic effect in patients with Non-24 is not known. Tasimelteon is an agonist at melatonin MT1 and MT2 receptors, which are thought to be involved in the control of circadian rhythms.
In the Phase 3 JET8 study (N=318), patients underwent a circadian challenge of 8 hours in advance to their usual bedtime. The study design induced the circadian challenge that travelers experience when crossing 8 time zones, which leads to jet lag disorder. The data showed significant and clinically meaningful effects on the primary endpoint (amount of sleep in the first 2/3 of the night) and various secondary endpoints (measures of sleep parameters [TST, LPS, WASO] and next day alertness [KSS, VAS]).
For the pre-specified primary endpoint, Hetlioz-treated patients experienced 216.4 minutes of sleep in the first 2/3 of the night vs 156.1 minutes in placebo-treated patients (difference 60.3 minutes; P <.0001). With regard to total sleep time, treatment with Hetlioz resulted in an improvement of 85.5 minutes over placebo (P <.0001).
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of August 16, 2019 for this indication.
Hetlioz is available as 20mg hardgel capsules in 30-count bottles.
For more information call (844) 438-5469 or visit Hetlioz.com.
This article originally appeared on MPR