Health Canada approves QUVIVIQ (daridorexant) for the management of
adult patients with insomnia
- QUVIVIQ is indicated for the management of adult patients with
insomnia, characterized by difficulties with sleep onset and/or
sleep maintenance.
- Idorsia Canada – led by General Manager Ron Morcos – aims to
make QUVIVIQ available in Canada by the end of the year.
Allschwil, Switzerland – May
3, 2023Idorsia Ltd (SIX: IDIA)
today announced that Health Canada has granted marketing
authorization for QUVIVIQ™ (daridorexant) for the management of
adult patients with insomnia, characterized by difficulties with
sleep onset and/or sleep maintenance, on April 28, 2023.1 Insomnia
is one of the most prevalent sleep disorders in Canada, affecting
over 2.2 million working age Canadians with an estimated annual GDP
lost in Canada due to reduced productivity associated with chronic
insomnia of USD 19.6 billion15, and impacting both physical and
mental health.2,3
QUVIVIQ is a dual orexin receptor antagonist (DORA) acting on
both orexin 1 and orexin 2 receptors equipotently. Rather than
inducing sleep through broad inhibition of brain activity
(sedation), QUVIVIQ blocks only the activation of orexin receptors
which promote wakefulness.1 Consequently, for patients with
insomnia, QUVIVIQ decreases the over-active 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, with at least 7 hours remaining prior to planned
awakening.1 Some patients may be treated with 25 mg once per
night.1
Jean-Paul Clozel, MD
and Chief Executive Officer,
commented:“I’m very pleased with the
positive decision from Health Canada, particularly seeing the
recommended dose of 50 mg, which we know works best. It is
estimated that 8.8% of adults in Canada suffer from chronic
insomnia, which we know takes its toll on their physical and mental
health. Sleep is one of the key pillars of health, so for these
patients, regular, nightly use of QUVIVIQ can have a big impact on
both their night’s sleep and their daily life. I am very proud of
the entire Idorsia team for achieving another regulatory approval
and I'm confident that Ron and his expert team in Canada will be
successful in transforming the Canadian sleep market.”
The decision by Health Canada is supported by robust Phase 3
results – published in The Lancet Neurology – which demonstrated
that at the recommended dose, QUVIVIQ improved sleep onset, sleep
maintenance and self-reported total sleep time in adults with
insomnia disorder.1 The effects of QUVIVIQ on sleep variables were
observed early in treatment and were maintained over time.1
The most frequently reported adverse reaction during the
double-blind treatment period in Phase 3 clinical trials with
QUVIVIQ (reported in at least 2% of patients and with a ≥ 1%
difference vs placebo) was headache.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 There was no
indication of non-medicinal use, and no evidence of withdrawal
symptoms upon drug discontinuation.1 This suggests that QUVIVIQ
does not produce physical dependence.1 No sign of rebound insomnia
was observed upon treatment discontinuation.1
The marketing authorization was also supported by a long-term
follow-up extension study, which together with the pivotal trials,
provides clinical data for up to 12 months of cumulative
treatment.1
For more information on the marketing authorization of QUVIVIQ
in Canada and important safety information, please review the
Product Monograph.
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 Canada of 8.8% of the adult 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 daridorexantDaridorexant
is a dual orexin receptor antagonist, acting on both orexin 1 and
orexin 2 receptors and equipotent on both.1 The orexin
neuropeptides (orexin A and orexin B) act on orexin receptors to
promote wakefulness.1 Daridorexant antagonizes the activation of
orexin receptors by the orexin neuropeptides and consequently
decreases the wake drive, allowing sleep to occur.1 In patients
with insomnia, daridorexant increases both non-REM and REM sleep
without altering proportion of sleep stages, as assessed by
polysomnography.1
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, the company aims to make
QUVIVIQ available to patients in Switzerland in June 2023. For more
information about QUVIVIQ in Switzerland, see the Patient
Information and Information for Healthcare Professionals.
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.
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.
The most frequently reported adverse reaction during the
double-blind treatment period in Phase 3 clinical trials with
daridorexant (reported in at least 2% of patients and with a ≥ 1%
difference vs placebo) was headache. The majority of adverse
reactions were mild to moderate in intensity.
References
- QUVIVIQ™ Canada Product Monograph
- 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.
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.comThe
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