The US Food and Drug Administration (FDA) has approved Vanda Pharmaceuticals’ HETLIOZ (tasimelteon) 20mg capsules for treatment of non-24-hour sleep-wake disorder (non-24).
HETLIOZ is the first FDA approved treatment for Non-24, which affects the majority those totally visually impaired.
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In this disorder, light does not enter a person’s eyes and they cannot synchronise their body clock to the 24-hour light-dark cycle.
The disorder results from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle.
Vanda president and chief executive officer Mihael Polymeropoulos said: "We are committed to providing much-needed support to patients with non-24 and facilitating access to this new therapeutic option."
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FDA approval of HETLIOZ was based on two major efficacy studies and the safety has been assessed in more than 1,300 people.
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By GlobalDataIn the trials, treatment with Hetlioz has showed significant improvement compared to placebo (inactive pill), both in increasing nighttime sleep and decreasing daytime sleep duration.
The most common adverse reactions of HETLIOZ observed in these trials were headaches, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection, and drowsiness.
According to the company, after taking HETLIOZ, patients should limit their activity to prepare for going to bed because the drug can impair the performance of activities requiring complete mental alertness.
Brigham and Women’s Hospital associate Neuroscientist Steven Lockley said those that are totally visually impaired have struggled with the problems brought on by non-24-hour sleep-wake disorder, sometimes for their entire life, without understanding what causes it and without being able to do anything about it.
"FDA approval of HETLIOZ means that, for the first time, these patients have access to an approved, safe and effective treatment for their difficult debilitating disorder," Lockley said.
The company intends to commercially market the sleep disorder drug HETLIOZ in the second quarter of 2014.
