FDA Approves Vanda's Hetlioz To Treat Sleep Disorder In Fully Blind Individuals

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) announced on Friday that the U.S. Food and Drug Administration has approved Hetlioz (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder. Hetlioz is the first FDA approved medication for 24-Hour Sleep-Wake Disorder.

Vanda anticipates making Hetlioz commercially available in the second quarter of 2014.

The most common adverse reactions in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection.

After taking Hetlioz, patients should limit their activity to preparing for going to bed, because Hetlioz can impair the performance of activities requiring complete mental alertness, the company said.

The company advised that use of Hetlioz should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of Hetlioz, and a greater risk of adverse reactions. Hetlioz should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of Hetlioz, with reduced efficacy.

The company noted that Hetlioz has not been studied in patients with severe hepatic impairment and is not recommended in these patients.