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FDA Approves Daridorexant for Treatment of Insomnia

Daridorexant (Quviviq, Idorsia Pharmaceuticals) is indicated in adults who have difficulty falling asleep and / or maintaining sleep.

The FDA has approved daridorexant (Quviviq, Idorsia Pharmaceuticals) for the treatment of people with insomnia, characterized by difficulty falling asleep and / or maintaining sleep.

The FDA approval of daridorexant in doses of 25 mg and 50 mg is based on a large clinical program that included 1,854 people with insomnia at more than 160 clinical trial sites in 18 countries.

“As stated in the definition of insomnia, the disorder is not just a nighttime problem, but affects a patient’s ability to function during the day. While the personal and societal burden of insomnia is well established, increasing the impact of insomnia on night and day remains critical to meeting the needs of patients, ”said Thomas Roth, PhD, director from the Sleep Disorder and Research Center at Henry Ford Hospital. , in a press release.

Daridorexant is a dual orexin receptor antagonist that blocks the binding of orexin neuropeptides, which is linked to sleep / wake regulation. The drug is believed to decrease hyperactive arousal, as opposed to sedating the brain, according to Idorsia Pharmaceuticals.

During the Phase 3 clinical program, daridorexant demonstrated significant improvement in objective measures of onset and maintenance of sleep, as well as total sleep time reported by individuals compared to placebo, according to Idorsia Pharmaceuticals.

The 50 mg dose of daridorexant, which was evaluated in 1 of 2 studies, demonstrated a significant reduction in patient-reported daytime sleepiness, using a valid instrument, and is consistent with the prescribing information of United States.

“The properties of daridorexant include potent inhibition of both orexin receptors, rapid absorption for sleep onset, and a pharmacokinetic profile such that approximately 80% of the daridorexant was removed after a night’s sleep to help minimize the effects. residuals, ”said Martine Clozel, MD, scientific director of Idorsia, in the release.

Clinical trials randomized people with insomnia to receive either daridorexant or placebo once a day in the evening for 3 months. One study randomized 930 individuals to receive daridorexant 50 mg, 25 mg, or placebo, while study 2 randomized 924 individuals to receive daridorexant 25 mg, 10 mg, or placebo.

At the end of the 3-month treatment period, both studies included a 7-day placebo discontinuation period, after which individuals could participate in a 9-month, double-blind, placebo-controlled extension study. . About 600 people received at least 6 months of cumulative treatment, of which 373 were treated for at least 12 months.

The primary efficacy endpoints for the two studies were change from baseline at month 1 and month 3 for latency to persistent sleep – a measure of sleep induction – and Awakening after Onset of Sleep (WASO) – a measure of sleep maintenance – objectively measured by polysomnography in a sleep laboratory.

The secondary endpoints included in the hierarchy of statistical tests with control for Type I errors were patient-reported total sleep time (sTST), assessed each morning at home using a validated questionnaire on the sleep diary.

In study 1, the 25 mg and 50 mg doses showed statistically significant improvement in all 3 measures compared to placebo, at months 1 and 3. In study 2, the 25 mg dose showed improvement. statistically significant on WASO and sTST at months 1 and 3 compared to placebo. The 10 mg dose did not show significant improvement over the 3 measurements.

The 50 mg dose also demonstrated a significant reduction in daytime sleepiness compared to placebo, as measured by the sleepiness domain score of the Insomnia Daytime Symptoms and Impacts questionnaire at months 1 and 3. Results on this endpoint of assessment for the 25 mg dose did not reach the statistical level. importance in one or the other study at both times.

The most common adverse events were headache and drowsiness or fatigue.

The 10 mg dose is not an FDA approved dose.

The FDA has recommended that daridorexant be classified as a controlled substance and that the drug should be available in May 2022, following planning by the U.S. Drug Enforcement Administration.

Reference

Idorsia receives US FDA approval for Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. Idorsie. Press release. January 10, 2022. Accessed January 10, 2022. https://www.idorsia.us/documents/us/media-releases/2201_us-fda-approval-quviviq-announcement.pdf