Idorsia launches QUVIVIQ (daridorexant) in Switzerland – a
first-in-class treatment for chronic insomnia disorder to improve
both nighttime symptoms and daytime functioning
- QUVIVIQ™ is indicated for the treatment of adult patients with
insomnia, characterized by symptoms present for at least three
months and considerable impact on daytime functioning
- QUVIVIQ, Switzerland's first approved dual orexin receptor
antagonist, offers a new targeted mechanism of action that
decreases nighttime overactive wakefulness in insomnia
Allschwil, Switzerland – June
12, 2023Idorsia Ltd (SIX: IDIA)
today announced that QUVIVIQ™ (daridorexant) is now available to
patients in Switzerland for the treatment of adult patients with
chronic insomnia characterized by symptoms present for at least
three months and considerable impact on daytime functioning.1
Chronic insomnia is one of the most prevalent sleep disorders in
Switzerland, affecting 9.2% of the working-age population,15 and
impacts both physical and mental health.3,4 According to a recent
report from the RAND Corporation,15 more than CHF 10 billion is
lost from annual GDP in Switzerland due to reduced productivity
associated with chronic insomnia.
QUVIVIQ is the first dual orexin receptor antagonist (DORA)
available in Switzerland for the treatment of chronic insomnia
disorder. Rather than inducing sleep through broad inhibition of
brain activity (sedation), QUVIVIQ blocks the activation of orexin
receptors1 known for their key role in wakefulness. Consequently,
QUVIVIQ decreases the wake drive, allowing sleep to occur, without
altering the proportion of sleep stages.1
The recommended dose of QUVIVIQ is one tablet of 50 mg once per
night, taken orally in the evening within 30 minutes before going
to bed.1 In certain circumstances, such as patients with moderate
hepatic impairment or who are taking moderate CYP3A4 inhibitors,
the recommended dose is 25 mg once per night.1
Jean-Paul Clozel, MD
and Chief Executive Officer, commented:“The
discovery of QUVIVIQ is the result of more than 20 years of
research by our own scientists at our headquarters here in
Switzerland. I am very happy that QUVIVIQ is now the first dual
orexin receptor antagonist available to Swiss patients suffering
from chronic insomnia disorder. This offers patients a new targeted
mechanism of action that decreases nighttime overactive wakefulness
in insomnia, and at the recommended dose of 50 mg, improves how
patients feel and function the next day. I’m confident that we can
transform the way chronic insomnia disorder is treated in
Switzerland.”
Alice Huisman, General Manager of Idorsia Switzerland
and Austria, commented:“I am delighted that we are now
able to provide Swiss patients and their physicians a new, targeted
treatment option for chronic insomnia disorder. The unique
characteristics of QUVIVIQ offer patients with chronic insomnia
disorder not only a better night sleep, both in terms of sleep
onset and duration, but also an improvement in daytime functioning.
The fact that Switzerland is our home market makes this milestone
particularly meaningful.”
The Phase 3 program was composed of two pivotal 3-month trials
and a long-term extension study, which provide clinical data for up
to 12 months of nightly treatment.1,5,17 The results of the 3-month
trials – published in The Lancet Neurology – demonstrated that at
the recommended dose, QUVIVIQ significantly improved sleep onset,
sleep maintenance and self-reported total sleep time in adults with
chronic insomnia disorder.5 A major focus of the trials was to
evaluate the impact of QUVIVIQ on daytime functioning in patients
with insomnia disorder, as assessed by IDSIQ, a patient-reported
outcomes instrument. The recommended dose of QUVIVIQ demonstrated
statistically significant improvement from baseline compared to
placebo in the daytime sleepiness domain of IDSIQ, which means
patients reported feeling less mentally and physically tired, less
sleepy and more energetic during the day, at months one and
three.1
In clinical trials, the most frequently reported adverse
reactions were headache and somnolence.1 The majority of adverse
reactions were mild to moderate in intensity.1 No evidence of a
dose-relationship for the frequency or severity of adverse
reactions was observed.1 The adverse reaction profile in elderly
patients was consistent with younger patients.1 Somnolence was
reported in 3% and 2% of patients treated with QUVIVIQ 25 mg and 50
mg, respectively, compared to 2% of subjects on placebo.1
Furthermore, no rebound insomnia or withdrawal symptoms indicative
of physical dependence upon treatment discontinuation were observed
in clinical studies, nor was there an indication of any drug abuse
potential.1
For more information on the marketing authorization of QUVIVIQ
in Switzerland, please review the Patient Information and
Information for Healthcare Professionals.
Notes to the editor
About insomnia
disorderInsomnia disorder is defined as difficulty
initiating or maintaining sleep, causing clinically significant
distress or impairment in important areas of daytime functioning.3
This impact on sleep quantity or quality should be present for at
least three nights per week, lasts for at least three months, and
occurs despite an adequate opportunity to sleep.3
Insomnia is a condition of overactive wake signaling and studies
have shown that areas of the brain associated with wakefulness
remain more active during sleep in patients with insomnia.8,9
Chronic insomnia is a common problem with an estimated prevalence
in Switzerland of 9.2% of the working-age population.15
Insomnia as a disorder is quite different from a brief period of
poor sleep, and it can take its toll on both physical and mental
health.3,4 It is a persistent condition with a negative impact on
daytime functioning.3 Idorsia’s research has shown that poor
quality sleep can affect many aspects of daily life, including the
ability to concentrate, mood, and energy levels.
The goal of treatments for insomnia is to improve sleep quality
and quantity, as well as daytime functioning, while avoiding
adverse events and next-morning residual effects. Current
recommended treatment of insomnia includes sleep hygiene therapy,
cognitive behavioral therapy, and pharmacotherapy.
About the orexin systemWake and sleep signaling
is regulated by intricate neural circuitry in the brain. One key
component of this process is the orexin system, which helps promote
wakefulness.7,10 There are two forms of orexin neuropeptides –
small protein-like molecules used by nerve cells (neurons) to
communicate with each other in the brain – orexin A and orexin
B.6,7 Orexin promotes wakefulness through its receptors OX1R and
OX2R.6,7 Together, these neuropeptides and receptors make up the
orexin system. The orexin system stimulates targeted neurons in the
wake system – leading to the release of several chemicals
(serotonin, histamine, acetylcholine, norepinephrine) – to promote
wakefulness.11 Under normal circumstances, orexin levels rise
throughout the day as wakefulness is promoted and then fall at
night.12 Overactivity of the wake system is an important driver of
insomnia.5,10
Idorsia’s research team has been working on the science of
orexin and orexin receptors since they were first described in
1998. The team’s initial work led to the conclusion that antagonism
of the orexin system was the key to preserving a natural sleep
architecture for patients with insomnia. With this as the target,
the team designed dual antagonists with the goal of rapid onset of
effect and duration of action sufficient to cover the night but
short enough to minimize any negative next-morning residual
activity at optimally effective doses.
About QUVIVIQ (daridorexant) in
insomnia disorderStudies over the
past decades have shown that hyperarousal processes in the brain
play a key role in the pathology of insomnia.6 Chronic insomnia
disorder is the result of continued brain hyperarousal that
requires sustained management with therapy suitable for daily use
over months.7 Orexin is a neuropeptide, a small protein-like
molecule, produced by the brain that promotes wakefulness.1,6
QUVIVIQ reduces nocturnal hyperarousal to improve sleep (onset and
maintenance) without next-morning residual effects in insomnia
patients, and thus improves daytime functioning.5
Global regulatory status of
QUVIVIQIn January 2022, QUVIVIQ was approved by
the US Food and Drug Administration (FDA) and subsequently made
commercially available in May 2022. For more information about
QUVIVIQ in the US, see the Full Prescribing Information. In April
2022, marketing authorization of QUVIVIQ was granted by the
European Commission and subsequently by the Medicines and
Healthcare products Regulatory Agency (MHRA) in Great Britain via
the European Commission Decision Reliance Procedure. For more
information about QUVIVIQ in the EU, see the Summary of Product
Characteristics. Launch preparations are underway in the major
European markets and QUVIVIQ was made available in both Italy and
Germany in November 2022. Marketing authorization of QUVIVIQ was
granted by Swissmedic in December 2022, and made available to
patients in Switzerland in June 2023. For more information about
QUVIVIQ in Switzerland, see the Patient Information and Information
for Healthcare Professionals. In April 2023, Health Canada approved
QUVIVIQ in Canada. For more information on the marketing
authorization of QUVIVIQ in Canada, see the Product Monograph.
The daridorexant Phase 3 registration
program5The Phase 3 registration program comprised two
three-month studies, together with a long-term double-blind
extension study. The program enrolled a total of 1,854 patients
with insomnia disorder. As insomnia often presents later in life,
and older adults are more susceptible to experience fragmented
sleep, early awakening and daytime sleepiness,13 around 40% of the
recruited population was at least 65 years of age.16
The placebo-controlled studies investigated the effects of three
doses of daridorexant (10 mg, 25 mg, and 50 mg) on sleep and
daytime functioning parameters, objectively in a sleep lab by
polysomnography and subjectively with a daily patient diary at
home. The impact of insomnia on patients’ daytime functioning was
measured daily using the sleepiness domain score from the Insomnia
Daytime Symptoms and Impacts Questionnaire (IDSIQ©) – a
patient-reported outcome (PRO) instrument developed and validated
according to the FDA Guidance for Industry.
More than 800 patients continued treatment in the 40-week
extension study, which measured the effect of all three doses vs.
placebo, generating data for long-term treatment of insomnia
disorder.17
Phase 3 data has been reported in The Lancet Neurology: The
pivotal studies demonstrated that daridorexant 50 mg significantly
improved sleep onset, sleep maintenance and self-reported total
sleep time at months one and three compared to placebo. The largest
effect was observed with the highest dose (50 mg), followed by 25
mg, while the 10 mg dose did not have a significant effect. In all
treatment groups the proportions of sleep stages were preserved, in
contrast to findings reported with benzodiazepine receptor
agonists.
A major focus of the trials was to evaluate the impact of
daridorexant on daytime functioning in patients with insomnia
disorder, as assessed by the IDSIQ. IDSIQ is a patient-reported
outcomes instrument specifically developed and validated according
to FDA guidelines, to measure daytime functioning in patients with
insomnia.14 The sleepiness domain score of the IDSIQ was
evaluated as a key secondary endpoint in both pivotal studies and
comparisons to placebo included type I error control for
multiplicity. Daridorexant 50 mg demonstrated highly statistically
significant improvement in daytime sleepiness at month one and
month three. The sleepiness domain score was not significantly
improved on 25 mg in either study at either timepoint.
The overall incidence of adverse events was comparable between
treatment groups.1 The most frequently reported adverse reactions
were headache and somnolence and, overall, the majority of adverse
reactions were mild to moderate in intensity.1 No evidence of a
dose-relationship for the frequency or severity of adverse
reactions was observed.1
References
- QUVIVIQ™ Patient Information and Information for Healthcare
Professionals. May 2022.
- Riemann, D., et al. Sleep. 2017;26(6):675-700.
- The Diagnostic and Statistical Manual of Mental Disorders (5th
ed.; DSM–5; American Psychiatric Association, 2013).
- Wardle-Pinkston S., et al. Sleep Med Rev. 2019;48.
- Mignot, E., et al. Lancet Neurol. 2022;21:125–39.
- Muehlan, C., et al. Expert Opin. Drug Metab. Toxicol.
2020;16(11):1063–1078.
- Muehlan, C., et al. J Psychopharmacol. 2020;34(3):326-335.
- Buysse, D.J., et al. Drug Discov Today Dis Models.
2011;8(4):129-137.
- Levenson, J.C., et al. Chest. 2015;147(4):1179-1192.
- Boof, M.L., et al. Eur J Clin Pharmacol.
2019;75(2):195-205.
- Clifford, B.S., et al. Trends Neurosci.
2001;24(12).726-31.
- Gotter, A.L., et al. BMC Neuroscience. 2013;14(1):14-19.
- Patel, D., et al. J Clin Sleep Med. 2018;14(06):1017–1024.
- Hudgens, S., et al. Patient. 2020.
doi:10.1007/s40271-020-00474-z.
- Hafner, M., et al. The Societal and Economic Burden of Insomnia
in Adults: An International Study. Santa Monica, CA: RAND
Corporation, 2023.
- Fietze I., et al. 2022 Oct;39(10):795-810.
- Kunz D, et al. CNS Drugs. 2022 Dec 9.
IDSIQ© 2020, University of Pittsburg. All rights reserved.
IDSIQ-14 derivative created 2020 by Idorsia Pharmaceuticals Ltd
under license and distributed by Idorsia Pharmaceuticals Ltd under
license. IDSIQ is further a registered trademark of Idorsia
Pharmaceuticals Ltd.
About IdorsiaIdorsia Ltd is reaching out for
more – We have more ideas, we see more opportunities and we want to
help more patients. In order to achieve this, we will develop
Idorsia into a leading biopharmaceutical company, with a strong
scientific core.
Headquartered near Basel, Switzerland – a European biotech-hub –
Idorsia is specialized in the discovery, development and
commercialization of small molecules to transform the horizon of
therapeutic options. Idorsia has a 20-year heritage of drug
discovery, a broad portfolio of innovative drugs in the pipeline,
an experienced team of professionals covering all disciplines from
bench to bedside, and commercial operations in Europe, Japan, and
the US – the ideal constellation for bringing innovative medicines
to patients.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol:
IDIA) in June 2017 and has over 1,300 highly qualified specialists
dedicated to realizing our ambitious targets.
For further information, please
contactAndrew C. WeissSenior Vice President, Head
of Investor Relations & Corporate CommunicationsIdorsia
Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58
844 10
10investor.relations@idorsia.commedia.relations@idorsia.comwww.idorsia.com
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