Full Press Release Details
Seventeen abstracts debut new data across narcolepsy and idiopathic hypersomnia
DUBLIN , June 1, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) today announced that the Company and its partners will present 17 new abstracts from across its neuroscience portfolio at SLEEP 2022, the 36 th annual meeting of the Associated Professional Sleep Societies (APSS) being held June 4-8, 2022 .
"Our latest research being presented at SLEEP 2022 provides important insights that benefit people living with complex and severe sleep disorders, deepening our understanding of these debilitating conditions and their overarching effects on patients," said Kelvin Tan, MB BCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals. "We continue to be pioneers in sleep medicine, building on the extensive data we've generated in narcolepsy and idiopathic hypersomnia. The breadth of data Jazz is presenting reinforces our passion for advancing research, elevating patient voices and addressing unmet needs through our transformational medicines."
Highlights at SLEEP 2022 include:
The SLEEP 2022 presentations and exhibit hall are available here . A list of poster presentations follows below:
| Presentation Title | Presenting Author | Date / Time (EST) / Session Title / Presentation Number |
| Narcolepsy Data | ||
| External Validation of an Enhanced Machine Learning Algorithm: Polysomnography-Based Narcolepsy-Like Feature Assessment and Clinician Notification in Routine Sleep Medicine Clinics | H Moore | Type: Poster Abstract ID: 082 Poster number: 53 Session date/time: June 7, 2022 at 5:15-7:15PM |
| Long-term Safety During a Clinical Trial of Lower-Sodium Oxybate in Participants With Narcolepsy With Cataplexy | RK Bogan | Type: Poster Abstract ID: 386 Poster number: 131 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Dosing and Reasons for Transitioning From Sodium Oxybate to Lower-Sodium Oxybate in People With Narcolepsy: Data From the Real-World TENOR Study | A Husain | Type: Poster Abstract ID: 388 Poster number: 133 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Weight Changes During Treatment With Lower-Sodium Oxybate in a Phase 3 Clinical Study in Patients With Narcolepsy | N Foldvary-Schaefer | Type: Poster Abstract ID: 393 Poster number: 136 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Efficacy and Safety in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate: Data From the Real-World TENOR Study | EB Leary | Type: Poster Abstract ID: 394 Poster number: 137 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Effectiveness and Treatment Optimization Among Participants With Narcolepsy Switching From Sodium Oxybate to Lower-Sodium Oxybate: Interim Data From the SEGUE Study | EB Leary | Type: Poster Abstract ID: 395 Poster number: 138 Session date/time: June 5, 2022 at 5:15-7:15PM |
| A Narcolepsy Detection Paradigm: Automated Nocturnal Detection and Notification of Sleep Onset Rapid Eye Movement Periods | A Cairns | Type: Poster Abstract ID: 408 Poster number: 151 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Children, Adolescents, and Their Providers: The Narcolepsy Assessment Partnership (CATNAP™) Pediatric Narcolepsy Registry: Baseline Demographics | W Macfadden | Type: Poster Abstract ID: 385 Poster number: 176 Session date/time: June 6, 2022 at 5:15-7:15PM |
| Idiopathic Hypersomnia Data | ||
| Weight Changes During Treatment With Lower-Sodium Oxybate in a Phase 3 Clinical Study in Patients With Idiopathic Hypersomnia | Y Dauvilliers | Type: Poster Abstract ID: 387 Poster number: 132 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Efficacy of Lower-Sodium Oxybate in the Treatment of Idiopathic Hypersomnia: Evaluation of Response Based on the Epworth Sleepiness Scale Score | R Rosenberg | Type: Poster Abstract ID: 389 Poster number: 134 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Efficacy of Lower-Sodium Oxybate in the Treatment of Idiopathic Hypersomnia: Evaluation of Response Based on the Idiopathic Hypersomnia Severity Scale Score | Y Dauvilliers | Type: Poster Abstract ID: 390 Poster number: 135 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Physician Perspective on Idiopathic Hypersomnia: Awareness, Diagnosis, and Impact on Patients | M Whalen | Type: Poster Abstract ID: 391 Poster number: 156 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Patient Perspective on Idiopathic Hypersomnia: Impact on Quality of Life and Satisfaction With the Diagnostic Process and Management | M Whalen | Type: Poster Abstract ID: 392 Poster number: 157 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Characteristics and Disease Burden of Patients With Idiopathic Hypersomnia With and Without Long Sleep Time: The Real-World Idiopathic Hypersomnia Outcomes Study (ARISE) | L Schneider | Type: Poster Abstract ID: 396 Poster number: 158 Session date/time: June 5, 2022 at 5:15-7:15PM |
| Investigator Sponsored Trials | ||
| Prevalence of Idiopathic Hypersomnia in the Wisconsin Sleep Cohort | PE Peppard | Type: Poster Abstract ID: 414 Poster number: 161 Session date/time: June 5, 2022 at 5:15-7:15PM |
| The Impact of Idiopathic Hypersomnia in Social and Romantic Relationships for Young Adults | R Davidson | Type: Poster Abstract ID: 416 Poster number: 163 Session date/time: June 5, 2022 at 5:15-7:15PM |
Important Safety Information
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:
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 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] 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 [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717
SOURCE Jazz Pharmaceuticals plc