Hetlioz(Tasimelteon)

Hetlioz (tasimelteon) is a melatonin receptor agonist. It was reviewed under application numbers 214517 and 205677-007, with a PDUFA goal date of December 1, 2020, and a review completion date of November 30, 2020.

In efficacy studies, tasimelteon demonstrated improvements in sleep quality and total sleep time. The DDSQ50 (sleep quality) showed an LS mean difference of 0.4 points versus placebo. For total sleep time (DDTST), there was a mean difference of 18.5 minutes versus placebo, and 21.1 minutes versus placebo across all nights. Additionally, 70% of patients showed positive improvement in DDSQ (sleep quality), and 15% showed an improvement of >1 hour in DDTST. Nightly awakenings for tasimelteon were 1.54 compared to 1.79 for placebo.

Safety data indicated that 21.3% of patients experienced infections and infestations in pooled data. There were no deaths reported in the NDA 205677 safety database. The NOAEL was 150 mg/kg/day, with a safety margin of 44-fold versus MRHD. High-dose males experienced an 11% decrease in body weight and a 1.2 mm decrease in ulna growth, while high-dose females experienced a 9% decrease in body weight and a 0.9 mm decrease in ulna growth.