Two oral presentations share results of
real-world impact of idiopathic hypersomnia and long-term
effectiveness of Epidiolex® (cannabidiol) in treatment-resistant
epilepsies
Thirteen abstracts underscore Jazz's diverse
neuroscience portfolio and pioneering efforts to continue advancing
the treatment of serious sleep disorders, rare epilepsy syndromes
and movement disorders
DUBLIN, April 10,
2024 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq:
JAZZ) today announced that 13 abstracts from across its
neuroscience portfolio and pipeline, including two oral
presentations, will be
featured at the 76th Annual American
Academy of Neurology Meeting (AAN) being held
April 13-18, 2024, in Denver.
Two encore datasets were selected for oral presentations,
including results from a real-world claims analysis that
demonstrated the increased risk of comorbid conditions, such as
stroke or cardiovascular disease, in individuals living with
idiopathic hypersomnia compared to those without the condition.
Additional data being presented include a post-hoc analysis from
the Epidiolex® (cannabidiol) oral solution Expanded
Access Program (EAP) that explores the long-term effectiveness of
Epidiolex on reduction of treatment-resistant focal-onset
seizures.
"Jazz's presentations at the 2024 AAN Annual Meeting reflect our
leadership in sleep and rare epilepsies, as well as our commitment
to developing therapies for debilitating, and often overlooked,
neurological disorders," said Rob
Iannone, MD, MSCE, executive vice president and global head
of research and development of Jazz Pharmaceuticals. "We remain
committed to expanding our knowledge of the patient experience,
including the real-world impact and effectiveness of our products,
in order to achieve our purpose of transforming the lives of
patients and their families."
Highlights at the 2024 AAN Annual Meeting
include:
- An oral presentation showcasing results from the Real-World
Idiopathic Hypersomnia Total Health Model (RHYTHM) study which,
using claims data, compared the comorbid conditions of individuals
diagnosed with idiopathic hypersomnia with those experienced by
individuals without idiopathic hypersomnia. Results revealed that
individuals with idiopathic hypersomnia experienced higher odds of
comorbid conditions across multiple clinical categories, including
cardiovascular conditions, reaffirming the importance of
considering the patient's full clinical profile when evaluating
treatment options for patients living with idiopathic
hypersomnia.
- A second oral presentation focusing on a post-hoc analysis that
examined the real-world outcomes and long-term effectiveness of
Epidiolex in treatment-resistant focal-onset seizures in
individuals who participated in the EAP. Findings showed that
Epidiolex was associated with a reduction in focal seizures
through 144 weeks, with an acceptable safety profile.
- Two posters assessing the impact of Xywav® (calcium,
magnesium, potassium, and sodium oxybates) oral solution, the first
and only low-sodium oxybate, on sleep inertia in individuals living
with idiopathic hypersomnia, including results from a Phase 3
trial.
- One poster reporting the final results from the SEGUE study of
adults with narcolepsy transitioning from Xyrem® (sodium
oxybate) oral solution, a high-sodium oxybate, to Xywav,
showing that participants switched from high-sodium to low-sodium
oxybate with minimal adjustments to their dosing.
- A poster reviewing key data from five clinical studies
evaluating the impact of all once- and twice-nightly high-sodium
oxybates on sleep quality, sleep architecture and measures of
disrupted nighttime sleep in narcolepsy. The review found that
oxybate was effective in improving measures of sleep architecture
and disrupted nighttime sleep in patients with narcolepsy.
Xyrem is indicated for the treatment of cataplexy and/or
excessive daytime sleepiness (EDS) in narcolepsy patients.
- Five posters examining real-world treatment patterns,
effectiveness and caregiver experiences with Epidiolex.
Notable presentations include updated interim results of seizure
and non-seizure outcomes from the cross-sectional BEhavior,
COgnition, and More with Epidiolex (BECOME) tuberous
sclerosis complex (TSC) caregiver survey, where the majority of
caregivers reported improvements in patient seizure and non-seizure
outcomes, including cognition, emotional and communication domains.
Additionally, a post-hoc analysis demonstrated long term
effectiveness of Epidiolex across all focal seizure subtypes
in patients with TSC in GWPCARE6 Open Label Extension trial.
- Two posters featuring Jazz's research with investigational
suvecaltamide (also known as JZP385) in essential tremor (ET) and
Parkinson's disease (PD) tremor. Presentations include insights
from a systematic review of existing literature on the epidemiology
and treatment patterns of patients with ET, emphasizing the need
for additional research in the space, and a study design overview
of the ongoing Phase 2, proof-of-concept study evaluating the
efficacy and safety of suvecaltamide on the functional impact of
tremor in PD.
The 2024 AAN Annual
Meeting abstracts are available online at
https://index.mirasmart.com/AAN2024/.
A full list of Jazz-sponsored presentations follows:
Presentation Title
|
Presenting
Author
|
Date / Time (MDT) /
Session Title / Presentation Number
|
Idiopathic Hypersomnia Data
|
Real-World Idiopathic
Hypersomnia Total Health Model (RHYTHM): Clinical Burden of
Patients Diagnosed With Idiopathic Hypersomnia
|
J Black
|
Type: Oral
Session Name: S36:
Sleep Neurology Highlights
Code:
S36.009
Session
Date/Time:
Wednesday, April 17,
5:06PM
|
Minimal Clinically
Important Difference for the Visual Analog Scale for Sleep Inertia
Using Data From a Phase 3 Trial of Low-Sodium Oxybate for
Idiopathic Hypersomnia
|
L Schneider
|
Type: Poster
Session Name: P10:
Sleep 3
Code:
P10.005
Session
Date/Time:
Wednesday, April
17,
11:45AM –
12:45PM
|
Efficacy of Low-Sodium
Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in
Participants with Idiopathic Hypersomnia
|
M Whalen
|
Type: Poster
Session Name: P10:
Sleep 3
Code:
P10.003
Session
Date/Time:
Wednesday, April
17,
11:45AM –
12:45PM
|
Narcolepsy
Data
|
Effectiveness and
Optimization of Low-Sodium Oxybate in Participants with Narcolepsy
Switching From Sodium Oxybate: Final Data From the Substitution of
Equal Grams of Uninterrupted Xyrem to Xywav (SEGUE)
Study
|
D Fuller
|
Type: Poster
Session Name: P10:
Sleep 3
Code:
P10.001
Session
Date/Time:
Wednesday, April
17,
11:45AM –
12:45PM
|
Effects of Oxybate on
Sleep, Sleep Architecture, and Disrupted Nighttime Sleep
|
J Black
|
Type: Poster
Session Name: P10:
Sleep 3
Code:
P10.006
Session
Date/Time:
Wednesday, April
17,
11:45AM –
12:45PM
|
Epilepsy Data
|
Long-term Effectiveness
of Cannabidiol (CBD) Against Focal-Onset Seizures in
Treatment-Resistant Epilepsies (TRE): Experience from the Expanded
Access Program (EAP)
|
YD Park
|
Type: Oral
Session Name: S29:
Epilepsy Diagnostics and Therapeutic
Code:
S29.005
Session
Date/Time:
Wednesday, April 17,
1:48PM
|
Real-World Treatment
Patterns of Patients with Dravet Syndrome (DS) and Lennox-Gastaut
Syndrome (LGS) in the United States (U.S.)
|
SV Kothare
|
Type: Poster
Session Name: P1:
Epilepsy / Clinical Neurophysiology (EEG): Pediatric Epilepsy
1
Code: P1.005
Session
Date/Time:
Sunday, April
14,
8:00AM –
9:00AM
|
Real-world Safety and
Effectiveness of Cannabidiol (CBD) in Adults with
Treatment-Resistant Epilepsies (TREs): Long-term Results From the
United States Expanded Access Program (EAP)
|
JP
Szaflarski
|
Type: Poster
Session Name: P8:
Epilepsy / Clinical Neurophysiology (EEG): Anti-seizure
Medications: Clinical Trials and Outcomes
Code: P8.002
Session
Date/Time:
Tuesday, April
16,
5:30PM –
6:30PM
|
Caregiver-Reported
Seizure Outcomes with Real-World Use of Cannabidiol (CBD) in
Tuberous Sclerosis Complex (TSC): Interim Results from the
BECOME-TSC Survey
|
MK Koenig
|
Type: Poster
Session Name: P8:
Epilepsy / Clinical Neurophysiology (EEG): Anti-seizure
Medications: Clinical Trials and Outcomes
Code: P8.005
Session
Date/Time:
Tuesday, April
16,
5:30PM
– 6:30PM
|
Caregiver-Reported
Nonseizure Outcomes with Real-World Use of Cannabidiol (CBD) in
Tuberous Sclerosis Complex (TSC): Interim Results From the
BECOME-TSC Survey
|
S Wilson
|
Type: Poster
Session Name: P8:
Epilepsy / Clinical Neurophysiology (EEG): Anti-seizure
Medications: Clinical Trials and Outcomes
Code: P8.010
Session
Date/Time:
Tuesday, April
16,
5:30PM
– 6:30PM
|
Long-Term Effectiveness
of Cannabidiol (CBD) Against Focal Seizures in Tuberous Sclerosis
Complex (TSC): Results From the GWPCARE6 Open-Label Extension (OLE)
Trial
|
JY Wu
|
Type: Poster
Session Name: P8:
Epilepsy / Clinical Neurophysiology (EEG): Anti-seizure
Medications: Clinical Trials and Outcomes
Code: P8.001
Session
Date/Time:
Tuesday, April
16,
5:30PM
– 6:30PM
|
Suvecaltamide
Data
|
Epidemiology and
Treatment Patterns in Essential Tremor: A Systematic
Review
|
J Lin
|
Type: Poster
Session Name: P3:
Movement Disorders: Essential Tremor and Other Tremor
Disorders
Code: P3.005
Session
Date/Time:
Sunday, April
14,
5:30PM
– 6:30PM
|
Design of a Phase 2
Study of Suvecaltamide in Moderate to Severe Parkinson's Disease
Tremor
|
T
Skarpaas
|
Type: Poster
Session Name: P9:
Movement Disorders: Parkinson's Disease Clinical Trials
Code: P9.009
Session
Date/Time:
Wednesday, April
17,
8:00AM –
9:00AM
|
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 Epidiolex®/Epidyolex®
(cannabidiol)
Epidiolex/Epidyolex is a prescription,
plant-derived cannabis-based medicine administered as an oral
solution which contains highly purified cannabidiol (CBD).
Cannabidiol, the active ingredient in Epidiolex, is a
cannabinoid that naturally occurs in the Cannabis sativa L.
plant. The precise mechanisms by which EPIDIOLEX exerts its
anticonvulsant effect in humans are unknown. Epidiolex was
approved by the U.S. Food and Drug Administration (FDA) for use in
the U.S., the European Commission (EC) for use in Europe, the Medicines and Healthcare products
Regulatory Agency (MHRA) for use in Great
Britain, the Therapeutic Goods Administration for use in
Australia, Swissmedic for use in
Switzerland, the Food &
Nutrition Services of the Israel Ministry of Health for use in
Israel, and the New Zealand
Medicines and Medical Devices Safety Authority for use in
New Zealand, is an oral solution
which contains highly purified cannabidiol (CBD). In the U.S.,
Epidiolex is indicated for the treatment of seizures
associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS)
or tuberous sclerosis complex (TSC) in patients one year of age and
older. Epidiolex has received approval in the European Union
under the tradename Epidyolex for adjunctive use in
conjunction with clobazam to treat seizures associated with LGS and
DS in patients two years and older, and for adjunctive use to treat
seizures associated with TSC, in patients two years of age and
older. Epidiolex has received Orphan Drug Designation (ODD)
from the U.S. FDA for the treatment of seizures associated with
LGS, DS, and TSC. Similarly, Epidyolex received ODD from the
European Medicines Agency (EMA) for the same indications.
Important Safety Information & Indications
CONTRAINDICATION: HYPERSENSITIVITY
EPIDIOLEX (cannabidiol) oral solution is contraindicated in
patients with a history of hypersensitivity to cannabidiol or any
ingredients in the product.
WARNINGS & PRECAUTIONS
Hepatic Injury:
EPIDIOLEX can cause dose-related
transaminase elevations. Concomitant use of valproate and elevated
transaminase levels at baseline increase this risk. Obtain
transaminase and bilirubin levels prior to starting treatment, at
1, 3, and 6 months after initiation of treatment, and periodically
thereafter, or as clinically indicated. Resolution of transaminase
elevations occurred with discontinuation of EPIDIOLEX, reduction of
EPIDIOLEX and/or concomitant valproate, or without dose reduction.
For patients with elevated transaminase levels, consider dose
reduction or discontinuation of EPIDIOLEX or concomitant
medications known to affect the liver (e.g., valproate or
clobazam). Dose adjustment and slower dose titration is recommended
in patients with moderate or severe hepatic impairment. Consider
not initiating EPIDIOLEX in patients with evidence of significant
liver injury. There have been postmarketing reports of cholestatic
or mixed patterns of liver injury. Elevated ammonia levels were
reported in some patients with transaminase elevations; most taking
concomitant valproate, clobazam, or both. Consider discontinuation
or dose adjustment of valproate or clobazam if ammonia is
elevated.
Somnolence and Sedation:
EPIDIOLEX can cause
somnolence and sedation that generally occurs early in treatment
and may diminish over time; these effects occur more commonly in
patients using clobazam and may be potentiated by other CNS
depressants.
Suicidal Behavior and Ideation:
Antiepileptic drugs
(AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts
or behavior. Inform patients, caregivers, and families of the risk
and advise them to monitor and report any signs of depression,
suicidal thoughts or behavior, or unusual changes in mood or
behavior. If these symptoms occur, consider if they are related to
the AED or the underlying illness.
Withdrawal of Antiepileptic Drugs:
As with most AEDs,
EPIDIOLEX should generally be withdrawn gradually because of the
risk of increased seizure frequency and status epilepticus.
ADVERSE REACTIONS:
The most common adverse reactions
in patients receiving EPIDIOLEX (≥10% and greater than placebo)
include transaminase elevations; somnolence; decreased appetite;
diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash;
insomnia, sleep disorder and poor-quality sleep; and infections.
Hematologic abnormalities were also observed.
PREGNANCY:
EPIDIOLEX should be used during pregnancy
only if the potential benefit justifies the potential risk to the
fetus. Encourage women who are taking EPIDIOLEX during pregnancy to
enroll in the EPIDIOLEX Pregnancy Surveillance Program and the
North American Antiepileptic Drug (NAAED) Pregnancy Registry.
DRUG INTERACTIONS:
Strong inducers of CYP3A4 and
CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect
exposure to CYP2C19 substrates (e.g., clobazam, diazepam,
stiripentol), orally administered P-gp substrates, or other
substrates (see full Prescribing Information). Consider dose
reduction of orally administered everolimus, with appropriate
therapeutic drug monitoring, when everolimus is combined with
EPIDIOLEX. A lower starting dose of everolimus is recommended when
added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and
valproate increases the incidence of liver enzyme elevations.
Pneumonia was observed more frequently with concomitant use of
EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other
concomitant medications may be necessary.
INDICATIONS:
EPIDIOLEX (cannabidiol) oral solution is
indicated for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous
sclerosis complex (TSC) in patients 1 year of age and older.
Please read the EPIDIOLEX full Prescribing Information for
additional important information here.
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.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including,
but not limited to, statements related to advancing the treatment
of serious sleep disorders, rare epilepsy syndromes and movement
disorders and other statements that are not historical facts. These
forward-looking statements are based on Jazz Pharmaceuticals'
current plans, objectives, estimates, expectations and intentions
and inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
and uncertainties associated with pharmaceutical product
development, and other risks and uncertainties affecting Jazz
Pharmaceuticals and its development programs, including those
described from time to time under the caption "Risk Factors" and
elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange
Commission filings and reports (Commission File No. 001-33500),
including Jazz Pharmaceuticals' Annual Report on Form 10-K for the
year ended December 31, 2023, and
future filings and reports by Jazz Pharmaceuticals. Other risks and
uncertainties of which Jazz Pharmaceuticals is not currently aware
may also affect Jazz Pharmaceuticals' forward-looking statements
and may cause actual results and the timing of events to differ
materially from those anticipated. The forward-looking statements
herein are made only as of the date hereof or as of the dates
indicated in the forward-looking statements, even if they are
subsequently made available by Jazz Pharmaceuticals on its website
or otherwise. Jazz Pharmaceuticals undertakes no obligation to
update or supplement any forward-looking statements to reflect
actual results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of
which the forward-looking statements were made.
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
References:
- Xywav (calcium, magnesium, potassium and sodium oxybates) oral
solution. Prescribing Information. Palo Alto, CA: Jazz
Pharmaceuticals, Inc. 2021.
- United States Drug Enforcement Agency. Drug
Scheduling. https://www.dea.gov/drug-information/drug-scheduling.
Accessed February 2024.
- Xyrem (sodium oxybate) oral solution. Prescribing
Information. Palo Alto, CA: Jazz Pharmaceuticals,
Inc. 2022.
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SOURCE Jazz Pharmaceuticals plc