FDA to Review Treatment for Jet Lag Disorder

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Hetlioz (tasimelteon) is a melatonin receptor agonist
Hetlioz (tasimelteon) is a melatonin receptor agonist

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.

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