FDA approval of QUVIVIQ (daridorexant) for the treatment of insomnia
pharmafile | January 10, 2022 | News story | Sales and Marketing |
Idorsia Ltd has announced the FDA approval of QUVIVIQ™ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia. Insomnia, a serious medical condition, is the most common sleep disorder in the US.
The FDA has recommended that QUVIVIQ be classified as a controlled substance. It is anticipated to be available to patients in May 2022, following scheduling by the US Drug Enforcement Administration.
QUVIVIQ has been approved for insomnia characterized by difficulties with sleep onset and/or sleep maintenance. The FDA approval of QUVIVIQ is based on an extensive clinical program, that included 1,854 adults with insomnia, in over 160 clinical trial sites across 18 countries. QUVIVIQ demonstrated significant improvement against a placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time.
“As noted in the definition of insomnia, the disorder is not only a problem of the night but affects a patient’s ability to function during the day,” Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Centre at Henry Ford Hospital, commented. “Although the personal and societal burden of insomnia is well established, elevating the impact insomnia has on both the night and day remains critical in addressing patients’ needs. I am encouraged to see a new advanced treatment option for the millions of adults struggling with insomnia.”
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.
“In our investigation of daridorexant we were able to demonstrate an improvement on objective sleep parameters, as well as improvement in patient-reported outcomes,” Guy Braunstein, MD and Head of Global Clinical Development of Idorsia, commented. “What is truly impressive, we have shown a dose response in the efficacy of daridorexant, with no increase in the rate of somnolence or fatigue with increasing doses.”
Ana Ovey
