The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg based on data from two late-stage trials.
Swiss drugmaker Idorsia said on Monday it has received the US Food and Drug Administration’s approval for its treatment for insomnia in adult patients.
The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg based on data from two late-stage trials that showed statistically significant and clinically meaningful improvements in sleep during the night and daytime functioning over a sustained period.
Insomnia is characterised by difficulty falling asleep or staying asleep, which leads to fatigue, trouble concentrating, and irritability
Talking about what sets the treatment apart from other drugs available in the market, Idorsia’s Chief Scientific Officer Martine Clozel told Reuters some drugs are fast acting, but their effect lasts for a shorter time, while other drugs cause additional sleep effects which linger through the day.
“What we have done is (created) a compound which does not have residual somnolence.”
The treatment belongs to a new class of medications called dual orexin receptor antagonists that work by blocking chemical messengers called orexins, which are responsible for keeping people awake.
Once launched, Idorsia’s drug will compete with Merck & Co’s Belsomra, approved in 2014, and Eisai Co’s Dayvigo, approved in 2019, both of which also target orexins.
The FDA has recommended Quviviq to be classified as a controlled substance because it can be addictive. The drug is anticipated to be available to patients in May 2022, Idorsia said.
Idorsia’s drug is also being reviewed by the European Medicines Association and the company expects a decision in the first quarter of 2022.
About 25 million adults in the United States suffer from insomnia, and 12 million of them take medications to help them sleep, according to the company.
Insomnia is a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep. You may still feel tired when you wake up. Insomnia can sap not only your energy level and mood but also your health, work performance and quality of life.
How much sleep is enough varies from person to person, but most adults need seven to eight hours a night.
At some point, many adults experience short-term (acute) insomnia, which lasts for days or weeks. It’s usually the result of stress or a traumatic event. But some people have long-term (chronic) insomnia that lasts for a month or more. Insomnia may be the primary problem, or it may be associated with other medical conditions or medications.
Insomnia symptoms may include:
- Difficulty falling asleep at night
- Waking up during the night
- Waking up too early
- Not feeling well-rested after a night’s sleep
- Daytime tiredness or sleepiness
- Irritability, depression or anxiety
- Difficulty paying attention, focusing on tasks or remembering
- Increased errors or accidents
- Ongoing worries about sleep
Sleep is as important to your health as a healthy diet and regular physical activity. Whatever your reason for sleep loss, insomnia can affect you both mentally and physically. People with insomnia report a lower quality of life compared with people who are sleeping well.
Complications of insomnia may include:
- Lower performance on the job or at school
- Slowed reaction time while driving and a higher risk of accidents
- Mental health disorders, such as depression, an anxiety disorder or substance abuse
- Increased risk and severity of long-term diseases or conditions, such as high blood pressure and heart disease