Posted by Michael Wonder on 02 Dec 2020
FDA approves Hetlioz (tasimelteon) for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome
1 December 2020 - Vanda Pharmaceuticals today announced that the U.S. FDA has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis syndrome.
The approval of Hetlioz for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome was based on a single placebo-controlled efficacy study in this rare disorder, which studied both adults with SMS taking the Hetlioz capsule and children with Smith-Magenis syndrome taking the liquid formulation.
