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news.US-based Vanda Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its HETLIOZ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
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HETLIOZ is claimed to be the first FDA approved medication for Non-24, a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle.
The disorder affects the majority of totally blind individuals and it is expected that about 80,000 people in the US have the disorder.
Vanda president and CEO Mihael Polymeropoulos said the FDA approval of HETLIOZ would not have been accomplished without the heroic efforts of blind patients and their advocates.
"We are committed to providing much needed support to patients with Non-24 and facilitating access to this new therapeutic option," Polymeropoulos said.
The FDA approval was based on two major efficacy studies and the safety has been evaluated in over 1,300 individuals.
In these trials, the most common adverse reactions observed were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection.
The company said that after taking HETLIOZ, patients should limit their activity to preparing for going to bed because the drug can impair the performance of activities requiring complete mental alertness.
The company intends to make HETLIOZ commercially available in the second quarter of 2014.
Image: Vanda’s HETLIOZ 20mg capsules will be commercially available in the second quarter of 2014. Photo: courtesy of amenic181/ freedigitalphotos.net