Idorsia is committed to further the science of sleep with a
symposium and poster presentations at World Sleep 2023
Allschwil, Switzerland – October 23, 2023
Idorsia Ltd (SIX: IDIA) today announced that it is committed to
further the science of sleep with a symposium and poster
presentations at World Sleep 2023, a global scientific congress
bringing the best of sleep medicine and research to Rio de Janeiro,
Brazil, October 20-25.
An Industry Symposium entitled "Managing chronic insomnia
disorder – what have we learned from clinical trials and real-world
practice?" will be hosted by Idorsia on Tuesday, October 24,
12:30-14:00 BRT, Room 37, 3rd floor.
Antonio Olivieri, Senior Vice President, Head of Global
Medical Affairs of Idorsia, commented:“Chronic insomnia
disorder is a distinct disease characterized by difficulty
initiating or maintaining sleep, as well as impaired daytime
functioning and is associated with significant acute and long-term
medical consequences. Overactive wake signaling in the brain,
promoted by the orexin system, is thought to be one of the key
factors causing chronic insomnia disorder. The orexin system
therefore provides a specific target for therapeutic intervention.
In this symposium, key learnings will be presented both from
clinical studies and real-world experience with daridorexant,
Idorsia’s dual orexin receptor antagonist.”
In addition to the symposium, the following posters are being
presented at World Sleep 2023:
- Di Marco T., et al. Effect of daridorexant on sleep
micro-architecture in adult patients with insomnia disorder – An
analysis of two pooled Phase 3 studies [Poster #070]
- Saskin P., et al. Real World Evidence of adverse events of
prescribed medications for insomnia [Poster #090]
- Boof M.-L., Repeated dosing (5 nights) of 50 mg daridorexant
in patients with severe obstructive sleep apnea: Effect on
sleep-disordered breathing and sleep [Poster #187]
- Lettieri C.J., et al. The Effects of Daridorexant 50 mg on
Patients with Comorbid Insomnia Disorder and Untreated Mild
Obstructive Sleep Apnea: A Subgroup Post-hoc Analysis of a Phase 3
Clinical Trial [Poster #209]
Furthermore, the following posters on the real-world experience
with daridorexant are being presented independently by three
research groups:
- Fernandes M., et al. Daridorexant treatment effectiveness for
chronic insomnia: A real-world retrospective study [Poster
#075]
- Palagini L., et al. Early experience with the new DORA
daridorexant in patients with insomnia disorder: results of a real
world study with a 3 months follow up period [Poster #085]
- Winter Y., et al. Influence of daridorexant on the
health-related quality of life in patients with chronic insomnia
[Poster #096]
The abstracts can be found in the Scientific
Program for World Sleep 2023.
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.2 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.2
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.7,8
Chronic insomnia is a common problem with an estimated prevalence
in Switzerland of 9.2% of the working-age population.14
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.2,3 It is a persistent condition with a negative impact on
daytime functioning.2 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.6,9 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.5,6 Orexin
promotes wakefulness through its receptors OX1R and OX2R.5,6
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.10 Under normal circumstances, orexin levels rise
throughout the day as wakefulness is promoted and then fall at
night.11 Overactivity of the wake system is an important driver of
insomnia.4,9
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 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.5 Chronic
insomnia disorder is the result of continued brain hyperarousal
that requires sustained management with therapy suitable for daily
use over months.6 Orexin is a neuropeptide, a small protein-like
molecule, produced by the brain that promotes wakefulness.5
Daridorexant reduces nocturnal hyperarousal to improve sleep (onset
and maintenance) without next-morning residual effects in insomnia
patients, and thus improves daytime functioning.4
Global regulatory status of daridorexantIn
January 2022, daridorexant was approved by the US Food and Drug
Administration (FDA). In April 2022, marketing authorization of
daridorexant 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. Marketing authorization of daridorexant was
granted by Swissmedic in December 2022. In April 2023, Health
Canada approved daridorexant in Canada.
The daridorexant Phase 3 registration
program4The 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,12 around 40% of the
recruited population was at least 65 years of age.15
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.16
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.13 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. The most frequently reported adverse reactions
were headache and somnolence and, overall, the majority of adverse
reactions were mild to moderate in intensity. No evidence of a
dose-relationship for the frequency or severity of adverse
reactions was observed.
References
- 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 and North
America – 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 1,200 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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