Idorsia Pharmaceuticals, US Inc. has announced that the US Food and Drug Administration (FDA) has approved QUVIVIQ™ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1. The FDA approval of QUVIVIQ is based on an extensive clinical program that included 1,854 adults with insomnia at over 160 clinical trial sites across 18 countries. Insomnia, a serious medical condition, is the most common sleep disorder in the US.
QUVIVIQ is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.
During the Phase 3 clinical program, QUVIVIQ demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance and patient-reported total sleep time. Consistent with the US prescribing information, the 50 mg dose of QUVIVIQ, which was evaluated in one of the two pivotal studies, demonstrated a significant reduction in patient-reported daytime sleepiness, using a validated instrument. The most common adverse reactions (in at least 5% of patients and greater than placebo) were headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and somnolence or fatigue (placebo: 4%, 25 mg: 6%, 50 mg: 5%).
The FDA has recommended that QUVIVIQ be classified as a controlled substance and it is anticipated to be available to patients in May 2022, following scheduling by the US Drug Enforcement Administration.
- QUVIVIQ Prescribing Information. Idorsia Pharmaceuticals US Inc. Jan/2022
Source: Idorsia Pharmaceuticals