Published On: Tue, Feb 4th, 2014

Vanda Pharmaceuticals, ‘Hetlioz’, drug to to treat non-24-hour sleep-wake disorder receives FDA’s nod

On January 31, 2013, The U.S Drug and Food Administration (FDA) approved Hetlioz (tasimelteon) to treat non-24-hour sleep-wake disorder in totally blind individuals. Hetlioz works as a melatonin receptor agonist that binds to and activates melatonin receptors within the brain.

Global Dispatch 200x119Non-24-hour sleep-wake disorder (“non-24”) is a chronic circadian rhythm disorder in the blind that causes problems with the timing of sleep. Even though blind individuals can perceive some light, about 100,000 blind individuals in the U.S perceive light and consequently cannot synchronize their body clock to the 24-hour light-dark cycle.

Individuals with non-24 have problems with falling and staying asleep as well as wake up feeling tired and groggy. In some cases the sleep cycle is completely reversed forcing the individual to sleep during the day and be awake at night.

“Non-24- hour sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted,” said Eric Bastings, M.D, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Hetlioz can improve the ability to sleep at night and to be active during the day.”

Hetlioz was studied among 104 participants in two clinical trials if totally blind individuals with non-24 disorder. Treatment with Heltlioz resulted in significant improvements when compared to the placebo (inactive pill), both in increasing nighttime sleep and reducing daytime sleep duration.

Common side effects noted were headaches, elevated liver enzymes (alanine aminotransferase) in the blood, nightmares or unusual dreams, disturbed night’s sleep, upper respiratory or urinary tract infection, and drowsiness.

Hetlioz can impair activities that require complete mental alertness. Hetlioz should be taken at the same time every night before bedtime and activities should be limited after taking the drug.

Hetlioz was reviewed under priority review. Priority review provides for an expedited review of drugs that treat serious conditions and have the potential to provide significant improvement in safety or effectiveness of the treatment, diagnosis, or prevention of such serious conditions. Hetlioz also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

Hetlioz is manufactured by Vanda Pharmaceuticals, Inc. of Washington, D.C.

Byline- Sarah Njoki Ndegwa, Public Health (HBS) & Psychology

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