Thirteen abstracts, including five
late-breaking abstracts, underscore Jazz's ongoing commitment to
advancing the understanding and treatment of serious sleep
disorders
Oral presentation of XYLO study design to
assess systolic blood pressure changes in oxybate patients after
switching to low-sodium Xywav®
DUBLIN, May 30, 2024
/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today
announced that thirteen abstracts, including five late-breaking
abstracts, featuring new data from across its sleep medicine
portfolio will be presented at SLEEP 2024, the 38th
annual meeting of the Associated Professional Sleep Societies being
held June 1-5, 2024, in Houston, Texas.
Two abstracts were selected for oral presentations, including
one that showcases the design elements from the Phase 4 XYLO study,
which measures changes in 24-hour average systolic blood pressure
after switching to low-sodium oxybate,
Xywav® (calcium, magnesium, potassium, and sodium
oxybates) oral solution from a high-sodium oxybate oral solution in
patients with narcolepsy. An additional oral presentation describes
a post-hoc analysis of Xywav efficacy and safety data in
patients with narcolepsy with or without a medical history of
psychiatric and/or neurologic comorbidities, which found that the
efficacy and safety of Xywav was similar among the two
groups.
"For nearly two decades, we have been dedicated to advancing and
delivering patient-centric solutions for those living with serious
conditions, such as narcolepsy and idiopathic hypersomnia, which
are chronic, debilitating neurologic sleep disorders that often
require lifelong treatment," said Kelvin Tan, MB BCh, MRCPCH,
senior vice president and chief medical officer of Jazz
Pharmaceuticals. "I am proud of the range of data being presented
at SLEEP 2024, which continues to demonstrate our commitment to the
sleep community and the importance of addressing the needs of
patients with these multi-symptom, and often underrecognized, sleep
disorders."
Additional highlights at SLEEP 2024 include:
- Two late-breaking poster presentations, which utilized the U.S.
National Health and Wellness Survey data to assess the burden
experienced by patients with idiopathic hypersomnia. One analysis
examined the clinical and humanistic burden on U.S. adults with
idiopathic hypersomnia, which demonstrates the substantial
comorbidity and health-related quality-of-life burden that patients
experience. The second analysis examined the healthcare resource
utilization and medical costs for U.S. adults with idiopathic
hypersomnia, which found patients reported significantly greater
economic burden, including work productivity, compared to those
without idiopathic hypersomnia.
- Four posters, including two late-breaking abstracts, showcase
design elements and baseline characteristics of participants
(enrolled as of February 5, 2024) in
the Develop hypersomnia Understanding by Evaluating low-sodium
oxybate Treatment (DUET) study. The DUET study is a Phase 4,
prospective study to assess the effect of Xywav treatment on
excessive daytime sleepiness, polysomnography parameters, and
functional outcomes in adults with idiopathic hypersomnia or
narcolepsy.
- A poster describing a post-hoc analysis of a Phase 3 trial
assessing the efficacy and safety of Xywav in participants
with narcolepsy with and without cardiovascular or cardiometabolic
comorbidities. The analysis demonstrates similar efficacy and
safety of Xywav in participants with narcolepsy with and
without these comorbidities.
The SLEEP 2024 abstracts are available online at the following
link: https://academic.oup.com/sleep/issue/47/Supplement_1.
A full list of Jazz presentations follows:
Presentation
Title
|
Lead
Author
|
Presentation Number
/ Session / Date & Time (CT)
|
Dual
Presentations
|
Design Elements for a
Switch Study From High- to Low-Sodium Oxybate Evaluating Blood
Pressure in Narcolepsy (XYLO)
|
V Somers
|
Oral Session:
O-18
Oral Presentation
Date/Time:
Tuesday, June 4,
4:30-4:45 PM
Poster Number:
259
Poster Session:
P-13
Poster Presentation
Date/Time: Monday, June 3, 10:00-10:45 AM
|
Efficacy and Safety of
Low-Sodium Oxybate in Narcolepsy Patients With/Without
Psychiatric/Neurologic Comorbidities
|
C Chepke
|
Oral Session:
O-18
Oral Presentation
Date/Time:
Tuesday, June 4,
4:45-5:00 PM
Poster Number:
263
Poster Session:
P-13
Poster Presentation
Date/Time: Monday, June 3, 10:00-10:45 AM
|
Poster
Presentations
|
Efficacy of Low-Sodium
Oxybate in Narcolepsy Patients With and Without Cardiovascular or
Cardiometabolic Disorders
|
BC Corser
|
Poster Number:
264
Poster Session:
P-13
Poster Presentation
Date/Time: Monday, June 3, 11:00-11:45 AM
|
Population
Pharmacokinetic and Exposure-Response Analyses Supporting
Individualized Dosing of Oxybate
|
C Chen
|
Poster Number:
256
Poster Session:
P-13
Poster Presentation
Date/Time: Monday, June 3, 11:00-11:45 AM
|
Supporting Patient
Safety With Oxybate Therapy: A Survey of Patients and
Prescribers
|
S Candler
|
Poster Number:
265
Poster Session:
P-13
Poster Presentation
Date/Time: Monday, June 3, 10:00-10:45 AM
|
Long-term Safety and
Timing of Adverse Events With Low-Sodium Oxybate in a Phase 3
Idiopathic Hypersomnia Study
|
RK Bogan
|
Poster Number:
254
Poster Session:
P-13
Poster Presentation
Date/Time: Monday, June 3, 11:00-11:45 AM
|
A Qualitative
Exploration of Patient and Healthcare Provider Perspectives on
Oxybate Treatments for Narcolepsy
|
S Candler
|
Poster Number:
407
Poster Session:
P-31
Poster Presentation
Date/Time: Tuesday, June 4, 10:00-10:45 AM
|
Baseline Features of
Participants With Narcolepsy: Insights From the DUET
Study
|
A Cairns
|
Poster Number:
437
Poster Session:
P-31
Poster Presentation
Date/Time: Tuesday, June 4, 10:00-10:45 AM
|
Baseline Features of
Participants With Idiopathic Hypersomnia: Insights From the DUET
Study
|
D Plante
|
Poster Number:
432
Poster Session:
P-31
Poster Presentation
Date/Time: Tuesday, June 4, 11:00-11:45 AM
|
The Clinical and
Humanistic Burden of Idiopathic Hypersomnia in the United States:
Analysis of the National Health and Wellness Survey
|
DT Plante
|
Poster Number:
434
Poster Session:
P-31
Poster Presentation
Date/Time: Tuesday, June 4, 11:00-11:45 AM
|
The Economic Burden of
Idiopathic Hypersomnia in the United States: Analysis of the
National Health and Wellness Survey
|
C
Drachenberg
|
Poster Number:
436
Poster Session:
P-31
Poster Presentation
Date/Time: Tuesday, June 4, 11:00-11:45 AM
|
Novel Design Elements
to Evaluate Sleep Architecture and Outcomes in an Idiopathic
Hypersomnia and Narcolepsy Study
|
DT Plante
|
Poster Number:
283
Poster Session:
P-42
Poster Presentation
Date/Time: Wednesday, June 5, 10:00-10:45 AM
|
Patient-Centric Design:
Incorporating Patient Input Into a Clinical Study of Idiopathic
Hypersomnia and Narcolepsy
|
DA Nichols
|
Poster Number:
304
Poster Session:
P-42
Poster Presentation
Date/Time: Wednesday, June 5, 11:00-11:45 AM
|
About Narcolepsy
Narcolepsy is a chronic, debilitating
neurologic sleep disorder characterized by excessive daytime
sleepiness (the inability to stay awake and alert during the day
resulting in the irrepressible need to sleep or unplanned lapses
into sleep or drowsiness), or EDS, and an inability to regulate
sleep-wake cycles normally.1 Patients with EDS due to
narcolepsy experience sleep attacks and, despite fighting the urge
to sleep, may unintentionally fall asleep for short
periods.2,3 These sleep attacks may happen at
inappropriate or potentially dangerous times such as during
driving, cycling, eating, or mid-conversation.4
There is no cure for narcolepsy, therefore this EDS is lifelong
and has a substantial negative impact on a person's ability to
function psychologically, socially and
professionally.5 Patients with narcolepsy are at
increased risk for hypertension, cardiometabolic
morbidity, stroke, myocardial infarction, heart failure,
cardiac arrest, and death.6,7,8,9 As narcolepsy is a
chronic condition that requires lifelong, nightly treatment, early
access to an effective, low-sodium treatment can transform lives
and reduce the impact of narcolepsy on a person's physical and
mental health.5
About Idiopathic Hypersomnia
Idiopathic
hypersomnia is an often debilitating, neurologic sleep disorder
that goes beyond chronic excessive daytime
sleepiness.10,11,12,13 Idiopathic hypersomnia is a
24-hour sleep disorder, and symptoms may include a prolonged but
non-restorative main (nighttime) sleep episode of more than 9
hours, or a sleep duration of 11 hours or longer over a 24-hour
period; cognitive impairment; long and unrefreshing naps; brain
fog, or the inability to focus for long periods of time; and severe
sleep inertia (prolonged difficulty waking, with frequent reentries
into sleep, confusion, and
irritability).10,11,12,13,14 Although there are
overlapping clinical features with narcolepsy, idiopathic
hypersomnia is a condition with its own specific diagnostic
criteria.13,15
Idiopathic hypersomnia is a debilitating illness that can
significantly affect social, educational, and occupational
functioning.16,17 In the U.S., approximately
37,000 adult patients have been diagnosed with idiopathic
hypersomnia and are actively seeking
healthcare.18 This low number of people may be due
to the many difficulties in identifying and diagnosing idiopathic
hypersomnia, as well as distinguishing it from other similar sleep
disorders. It is estimated that far fewer patients are currently
receiving pharmacological treatment for their idiopathic
hypersomnia.18,19,20,21
About Xywav® (calcium, magnesium, potassium, and
sodium oxybates) oral solution
Xywav is a
low-sodium oxybate approved by the U.S. Food and Drug
Administration (FDA) for the treatment of cataplexy or
excessive daytime sleepiness (EDS) in patients 7 years of age and
older with narcolepsy. The FDA recognized seven years of Orphan
Drug Exclusivity for Xywav for the treatment of
cataplexy or EDS in patients 7 years of age and older with
narcolepsy. The Office of Orphan Product Development (OOPD) at the
FDA also published its summary of clinical superiority findings
for Xywav for the treatment of cataplexy or EDS in
patients 7 years of age and older with narcolepsy by means of
greater cardiovascular safety compared to
Xyrem® (sodium oxybate) oral solution. The decision
of the OOPD is based on the FDA findings
that Xywav provides a greatly reduced chronic
sodium burden compared
to Xyrem. Xywav has 131 mg of sodium
at the maximum recommended nightly dose. Xywav is
comprised of a unique composition of cations resulting in 92% less
sodium, or a reduction of approximately 1,000 to 1,500
mg/night. Xywav is the only low-sodium oxybate
therapy approved by the FDA, and the only oxybate that does not
carry a warning in the label related to use in patients sensitive
to high sodium intake.
Xywav is also the first and
only U.S. FDA-approved treatment option for idiopathic
hypersomnia in adults. The FDA recognized seven years of Orphan
Drug Exclusivity for Xywav for the treatment of
idiopathic hypersomnia in adults. Xywav is the
only FDA-approved treatment studied across the multiple symptoms of
idiopathic hypersomnia, such as EDS, sleep inertia (severe
grogginess or confusion when waking up), long sleep duration and
cognitive impairment. Xywav can be administered as
a twice- or once-nightly regimen for the treatment of idiopathic
hypersomnia in adults.
The exact mechanism of action of Xywav in the
treatment of adults with idiopathic hypersomnia and of cataplexy
and EDS in narcolepsy is unknown. It is hypothesized that the
therapeutic effects of Xywav are mediated through
GABAB actions during sleep at noradrenergic and
dopaminergic neurons, as well as thalamocortical
neurons.1 The U.S. Drug Enforcement
Agency (DEA) has designated Xywav as a
Schedule III medicine. The DEA defines Schedule III drugs,
substances, or chemicals as drugs with a moderate to low potential
for physical and psychological
dependence.1,2 Because of the risks of central
nervous system (CNS) depression and abuse and
misuse, Xywav is available only through a
restricted program under a Risk Evaluation and Mitigation Strategy
(REMS) called the XYWAV and XYREM REMS.
Important Safety Information for Xywav
WARNING: Taking XYWAV with other central nervous system (CNS)
depressants such as medicines used to make you or your child fall
asleep, including opioid analgesics, benzodiazepines, sedating
antidepressants, antipsychotics, sedating anti-epileptic medicines,
general anesthetics, muscle relaxants, alcohol, or street drugs,
may cause serious medical problems, including trouble breathing
(respiratory depression), low blood pressure (hypotension), changes
in alertness (drowsiness), fainting (syncope), and death.
The active ingredient of XYWAV is a form of gamma
hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with
other drugs that cause changes in alertness (or consciousness) has
caused serious side effects. These effects include seizures,
trouble breathing (respiratory depression), changes in alertness
(drowsiness), coma, and death. Call your doctor right away if you
or your child has any of these serious side effects.
Because of these risks, you have to go through the XYWAV and
XYREM REMS to have your or your child's prescription for XYWAV
filled.
Do not take XYWAV if you take or your child takes other
sleep medicines or sedatives (medicines that cause sleepiness),
drinks alcohol, or has a rare problem called succinic semialdehyde
dehydrogenase deficiency.
Keep XYWAV in a safe place to prevent abuse and misuse. Selling
or giving away XYWAV may harm others and is against the law. Tell
your doctor if you have ever abused or been dependent on alcohol,
prescription medicines, or street drugs.
Anyone who takes XYWAV should not do anything that requires them
to be fully awake or is dangerous, including driving a car, using
heavy machinery, or flying an airplane, for at least 6 hours after
taking XYWAV. Those activities should not be done until you know
how XYWAV affects you or your child.
XYWAV can cause serious side effects, including the
following:
- Breathing problems, including slower breathing, trouble
breathing, and/or short periods of not breathing while sleeping
(sleep apnea). People who already have breathing or lung problems
have a higher chance of having breathing problems when they use
XYWAV.
- Mental health problems, including confusion, seeing or
hearing things that are not real (hallucinations), unusual or
disturbing thoughts (abnormal thinking), feeling anxious or upset,
depression, thoughts of killing yourself or trying to kill
yourself, increased tiredness, feelings of guilt or worthlessness,
or difficulty concentrating. Tell your doctor if you or your child
have or had depression or have tried to harm yourself or
themselves. Call your doctor right away if you have or your
child has symptoms of mental health problems or a change in weight
or appetite.
- Sleepwalking. XYWAV can cause sleepwalking, which can
cause injuries. Call your doctor if this occurs.
The most common side effects of XYWAV in adults include nausea,
headache, dizziness, anxiety, insomnia, decreased appetite,
excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth,
parasomnia (a sleep disorder that can include abnormal dreams,
abnormal rapid eye movement (REM) sleep, sleep paralysis, sleep
talking, sleep terror, sleep-related eating disorder, sleep
walking, and other abnormal sleep-related events), somnolence,
fatigue, and tremor.
The most common side effects of XYREM (which also contains
oxybate like XYWAV) in children include nausea, bedwetting,
vomiting, headache, weight decrease, decreased appetite, dizziness,
and sleepwalking.
XYWAV can cause physical dependence and craving for the medicine
when it is not taken as directed. These are not all the possible
side effects of XYWAV.
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.
Please see full Prescribing Information, including Boxed
Warning, here:
https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf
About Xyrem® (sodium oxybate)
Xyrem
oral solution, CIII, is a product approved by the U.S. Food and
Drug Administration (FDA) for both cataplexy and excessive daytime
sleepiness in narcolepsy in adult and pediatric patients ages 7 and
older.3 Xyrem may only be dispensed to patients
enrolled in the XYWAV and XYREM REMS. Xyrem was first
approved in the U.S. in 2002, based on clinical trial data in
adults.
Important Safety Information for Xyrem
WARNING:
Taking XYREM with other CNS depressants such as medicines used to
make you or your child fall asleep, including opioid analgesics,
benzodiazepines, sedating antidepressants, antipsychotics, sedating
anti-epileptic medicines, general anesthetics, muscle relaxants,
alcohol, or street drugs, may cause serious medical problems,
including trouble breathing (respiratory depression), low blood
pressure (hypotension), changes in alertness (drowsiness),
dizziness (syncope), and death.
XYREM is a form of gamma hydroxybutyrate (GHB). Abuse or
misuse of illegal GHB alone or with other drugs that cause changes
in alertness (or consciousness) has caused serious side effects.
These effects include seizures, trouble breathing (respiratory
depression), changes in alertness (drowsiness), coma, and
death.
Because of these risks, you have to go through the XYWAV and
XYREM REMS to have your or your child's prescription for XYREM
filled.
Do not take XYREM if you take or your child
takes other sleep medicines or sedatives (medicines that
cause sleepiness), drink alcohol, or have a rare problem called
succinic semialdehyde dehydrogenase deficiency.
Keep XYREM in a safe place to prevent abuse and misuse. Selling
or giving away XYREM may harm others and is against the law. Tell
your doctor if you have ever abused or been dependent on alcohol,
prescription medicines, or street drugs.
Anyone who takes XYREM should not do anything that requires them
to be fully awake or is dangerous, including driving a car, using
heavy machinery, or flying an airplane, for at least 6 hours after
taking XYREM. Those activities should not be done until you know
how XYREM affects you or your child.
XYREM can cause serious side effects, including the
following:
- Breathing problems, including slower breathing, trouble
breathing, and/or short periods of not breathing while sleeping
(sleep apnea). People who already have breathing or lung problems
have a higher chance of having breathing problems when they use
XYREM.
- Mental health problems, including confusion, seeing or
hearing things that are not real (hallucinations), unusual or
disturbing thoughts (abnormal thinking), feeling anxious or upset,
depression, or thoughts of killing yourself or trying to kill
yourself. Tell your doctor if you or your child have or had
depression or have tried to harm yourself. Call your doctor
right away if you have or your child has symptoms of mental health
problems.
- Sleepwalking. Sleepwalking can cause injuries. Call your
doctor if you or your child starts sleepwalking. Your doctor should
check you or your child.
Tell your doctor if you are or your child is on a
salt-restricted diet or if you have or your child has high blood
pressure, heart failure, or kidney problems. XYREM contains a lot
of sodium (salt) and may not be right for you or your child.
The most common side effects of XYREM include nausea,
sleepiness, dizziness, vomiting, bedwetting, and tremor (in
adults). In pediatric patients, headache, decreased appetite, and
weight decrease were also common. Your side effects may increase
when you take higher doses of XYREM. XYREM can cause physical
dependence and craving for the medicine when it is not taken as
directed. These are not all the possible side effects of XYREM.
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.
Please find full prescribing information here:
http://pp.jazzpharma.com/pi/xyrem.en.USPI.pdf
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
— often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines, including leading therapies for
sleep disorders and epilepsy, and a growing portfolio of cancer
treatments. Our patient-focused and science-driven approach powers
pioneering research and development advancements across our robust
pipeline of innovative therapeutics in oncology and neuroscience.
Jazz is headquartered in Dublin,
Ireland with research and development laboratories,
manufacturing facilities and employees in multiple countries
committed to serving patients worldwide. Please visit
www.jazzpharmaceuticals.com for more information.
Media Contact:
Kristin
Bhavnani
Head of Global Strategic Brand Engagement
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Investors:
Andrea N.
Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717
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Narcolepsy.
https://www.ninds.nih.gov/health-information/disorders/narcolepsy?search-term=narcolepsy#toc-what-is-narcolepsy-. Accessed
April 2024.
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patients with narcolepsy with cataplexy, narcolepsy without
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Pharmaceuticals, Inc. 2021.
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https://www.dea.gov/drug-scheduling. Accessed April 2024.
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Palo Alto, CA: Jazz
Pharmaceuticals, Inc. 2022.
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