The US Food and Drug Administration (FDA) has accepted a supplemental new drug application from Vanda Pharmaceuticals for Hetlioz (tasimelteon) in insomnia, with a Prescription Drug User Fee Act target action date of March 4, 2024.
Hetlioz is currently FDA-approved to treat non-24-hour sleep-wake disorder and sleep disturbances in Smith-Magenis Syndrome.
A trial in which chronic primary insomnia patients were randomized to receive either 20 mg or 50 mg of tasimelteon or placebo over the course of four weeks demonstrated that tasimelteon was able to improve latency to persistent sleep significantly, and this effect persisted for the four-week duration of the study.
Vanda is continuing to pursue FDA approval for Hetlioz in jet lag disorder, according to the company’s third-quarter financial results and business updates.
During the third quarter, Hetlioz’ net product sales were $17.5 million, a 58% decrease compared to $41.3 million in the third quarter of 2022, a drop the company attributed to launch of a generic version of Hetlioz in the US.
Hetlioz’ net product sales were $79.1 million in the first nine months of 2023, a 34% decrease compared to $119.6 million in the first nine months of 2022, also attributed to the generic launch.
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