Ad hoc announcement pursuant to Art. 53 LR
- The approval of QUVIVIQ™ – 25 & 50 mg – is based on a robust Phase 3 clinical program that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time
- Idorsia’s first approved medicine is a new treatment option for the approximately 25 million American adults living with insomnia2,3,4
Allschwil,
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
“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. 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.”
Dr
“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. 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.”
“I am extremely proud to be leading the US organization of such a forward-thinking and patient-centric organization like
“In our investigation of daridorexant we were able to demonstrate an improvement on objective sleep parameters, as well as improvement in patient-reported outcomes. 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.”
Phase 3 Clinical Program
The efficacy of QUVIVIQ was evaluated in two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, Study 1 (NCT03545191) and Study 2 (NCT03575104).
A total of 1854 patients with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5®) insomnia were randomized to receive QUVIVIQ or placebo once daily, in the evening, for 3 months. Study 1 randomized 930 subjects to QUVIVIQ 50 mg (N = 310), 25 mg (N = 310) or placebo (N = 310). Study 2 randomized 924 subjects to QUVIVIQ 25 mg (N = 309), 10 mg (N = 307), or placebo (N = 308). The 10 mg dose is not an approved dose.
At the end of the 3-month treatment period, both studies included a 7-day placebo run-out period, after which patients could enter a 9-month, double-blind, placebo-controlled extension study (Study 3, NCT03679884). A total of 600 subjects were treated for at least 6 months of cumulative treatment, including 373 treated for at least 12 months.
Primary efficacy endpoints for both studies were the change from baseline to Month 1 and Month 3 in Latency to Persistent Sleep (LPS) and Wake After Sleep Onset (WASO), measured objectively by polysomnography in a sleep laboratory. LPS is a measure of sleep induction and WASO is a measure of sleep maintenance.
Secondary endpoints included in the statistical testing hierarchy with Type I error control were patient-reported Total Sleep Time (sTST), evaluated every morning at home using a validated Sleep Diary Questionnaire (SDQ).
In Study 1, doses of 25 and 50 mg QUVIVIQ showed a statistically significant improvement vs placebo on polysomnography (LPS, WASO) and self-reported total sleep (sTST), at Month 1 and Month 3.
In Study 2, QUVIVIQ 25 mg showed a statistically significant improvement vs placebo on WASO and sTST at Month 1 and Month 3. QUVIVIQ 10 mg did not show a statistically significant improvement on LPS, WASO, or sTST at Month 1 or Month 3.
The efficacy of QUVIVIQ was similar across subgroups based on age, sex, race, and region.
The 50 mg dose of QUVIVIQ, which was evaluated in one of the two pivotal studies, also demonstrated significant reduction in daytime sleepiness compared to placebo, as measured by the sleepiness domain score from the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)7 at month 1 and month 3 (key secondary endpoint). Results on this endpoint for the 25mg dose did not reach statistical significance in either study at both timepoints.
The most common reported 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%).
For more information see the Full Prescribing Information (PI and Medication Guide).
Important Safety Information
QUVIVIQ is a prescription medicine for adults
Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy).
QUVIVIQ may cause serious side effects, including:
- Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.
- Do not take more QUVIVIQ than prescribed.
- Do not take QUVIVIQ unless you are able to stay in bed for at least 7 hours before you must be active again.
- Take QUVIVIQ at night within 30 minutes before going to bed.
QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence.
Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of depression, mental illness, or suicidal thoughts or actions; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
- have lung or breathing problems, including sleep apnea
- have liver problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
- Taking QUVIVIQ with certain medicines can cause serious side effects. QUVIVIQ may affect the way other medicines work and other medicines may affect the way QUVIVIQ works.
- Do not take QUVIVIQ with other medicines that can make you sleepy unless instructed by your healthcare provider.
What should I avoid while taking QUVIVIQ?
- Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.
- Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.
QUVIVIQ may cause other serious side effects, including:
- Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
- Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
- Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.
The most common side effects of QUVIVIQ are headache and sleepiness.
These are not the only side effects of QUVIVIQ. Call your doctor for advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Notes to the editor
About Insomnia
According to 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 defined as difficulty initiating and/or maintaining sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.
Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.
Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.2 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.3 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.4,5,6
About Dr.
After serving as president of the
In 2002,
References
- QUVIVIQ Prescribing Information.
Idorsia Pharmaceuticals US Inc. Jan/2022 - Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family
Med Prim Care . 2016;5(4):780-784. doi:10.4103/2249-4863.201153. - Ustinov Y, Lichstein KL, Wal GS, Taylor DJ,
Riedel BW , Bush AJ. Association between report of insomnia and daytime functioning. Sleep Med. 2010 Jan;11(1):65-8. doi: 10.1016/j.sleep.2009.07.009. Epub 2009 Sep 23. - Olfson M, Wall M, Liu SM, Morin CM, Blanco C. Insomnia and Impaired Quality of Life in
the United States . J Clin Psychiatry. 2018 Sep 11;79(5):17m12020. doi: 10.4088/JCP.17m12020. - Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care. 2006 May;12(8 Suppl): S214-20. PMID: 16686591.
- de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia and risk of dementia in older adults: Systematic review and meta-analysis. J Psychiatr Res. 2016 Jun;77:109-15. doi: 10.1016/j.jpsychires.2016.02.021. Epub 2016
Mar 8 . PMID: 27017287. - Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D,
Benes H. Development and validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2020;14(2): 249-268. https://doi. org/ 10. 1007/ s40271- 020- 00474-z
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