The approval was based on data from a broad clinical program of 1,854 adults with insomnia conducted at more than 160 clinical sites in 18 countries.
The U.S. Food and Drug Administration (FDA) approved Idorsia Pharmaceutical’s Quviviq (daridorexant) for adults with insomnia. Insomnia is described as difficulties with sleep onset and/or sleep maintenance.
It was approved at two doses, 25 mg and 50 mg. The approval was based on data from a broad clinical program of 1,854 adults with insomnia conducted at more than 160 clinical sites in 18 countries.
In the Phase III program, the drug showed significant improvement compared to placebo on objective measures of sleep onset and sleep maintenance, as well as patient-reported total sleep time. The 50 mg dose, which was evaluated in one of the Phase III trials, demonstrated a significant drop in patient-reported daytime sleepiness.
In at least 5% of patients, the most common adverse events were headache, somnolence or fatigue.
The drug is a dual orexin receptor antagonist. It blocks the binding of orexins, which are neuropeptides that promote being awake. It is believed to decrease overactive wakefulness, compared to treatments that typically sedate the brain.
Per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), insomnia is defined as “a combination of difficulty obtaining sufficient sleep and dissatisfaction with sleep combined with a significant negative impact on daytime functioning.” Chronic insomnia is difficult getting to sleep or staying asleep at least three nights per week for at least three months, despite having plenty of opportunities to sleep.
Insomnia is the most common sleep disorder, hitting about 25 million adults in the U.S. Long-term insomnia is associated with psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.
“After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and of the potential of orexin receptor antagonism, we designed daridorexant to help address several issues people with insomnia face,” said Dr. Martine Clozel, Chief Scientific Officer of Idorsia. “Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects.”
The emphasis on residual effects is largely daytime sleepiness after taking the drug, which is common with other insomnia medications. Other insomnia drugs on the market that target orexins include Merck’s Belsomra, which was approved in 2014, and Eisai’s Dayvigo, approved in 2019.
Because Quviviq can be addictive, the FDA has recommended it be classified as a controlled substance. The company expects to launch the drug in May 2022.
Patricia Torr, President and General Manager of Idorsia U.S., stated, “I am extremely proud to be leading the U.S. organization of such a forward-thinking and patient-centric organization like Idorsia. With this first FDA approval for our company, Quiviviq provides a new treatment option that can help adults with insomnia get to sleep faster and stay asleep longer, which we know plays an important role in how they feel the next day. It’s an incredibly exciting time for us and I can’t wait to transform the treatment paradigm in the U.S. We have a differentiated product, an amazing team, and an innovative strategy, giving me absolute confidence that we can make Quviviq a great success.”
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