Vanda Pharmaceuticals (VNDA) announced the publication of an article in PLOS One, an open-access journal, in which Hetlioz met its primary endpoint, demonstrating a mean improvement in latency to persistent sleep, or LPS, from baseline to the average of Nights 1 and 8 of 44.9 minutes – 20mg – and 46.3 minutes – 50mg – versus 28.2 minutes – placebo -. Improvements in LPS persisted through the follow-up time points. Additionally, Hetlioz use was not associated with cognitive or mood changes, and neither rebound nor withdrawal effects were observed after discontinuation. Vanda is continuing to pursue FDA approval for Hetlioz in the treatment of insomnia and Jet Lag Disorder and is continuing to develop Hetlioz for the treatment of several other sleep disorders including Delayed Sleep Phase Disorder and pediatric insomnia.
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