Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution in Idiopathic Hypersomnia
Jazz submitted to FDA the clinical study report for the Phase 3 study of Xywav in a double-blind, multicenter, placebo-controlled, randomized withdrawal study evaluating the efficacy and safety of Xywav in adult patients with idiopathic hypersomnia in
The Phase 3 study results will be presented during the Clinical Trials Plenary Session of the 2021
Webcast/conference call details
The company will host an audio webcast on
An archived version of the webcast will be available for at least one week on the Investors section of the company's website. An audio replay will be available through
About Idiopathic Hypersomnia
Idiopathic hypersomnia is an often debilitating, neurologic sleep disorder characterized by chronic 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) that is not caused by other medical, behavioral or psychiatric conditions.1,2,3,4 Symptoms may also include a prolonged main sleep episode of more than 9 hours or a sleep duration of 11 hours or longer over a 24-hour period, prolonged, non-restorative nighttime sleep and long and unrefreshing naps, and severe sleep inertia (prolonged difficulty waking, with frequent reentries into sleep, confusion, and irritability).1,2,3,4 Idiopathic hypersomnia is a condition with its own specific diagnostic criteria.1 Idiopathic hypersomnia is a debilitating illness that can significantly affect social, school and occupational functioning.4,5 Insurance claims data suggest the number of people diagnosed with idiopathic hypersomnia and actively seeking healthcare is 37,000 patients in the
More information about Xywav, including Full Prescribing Information and Medication Guide, is available here. <http://pp.jazzpharma.com/pi/xywav.en.USPI.pdf>
About Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution
Xywav, also known as JZP-258, is a lower-sodium oxybate approved by the
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 Program 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. Sleepwalking can cause injuries. Call your doctor if you or your child starts sleepwalking. Your doctor should check you or your child.
The most common side effects of XYWAV in adults include headache, nausea, dizziness, decreased appetite, 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), diarrhea, excessive sweating (hyperhidrosis), anxiety and vomiting.
The most common side effects of XYWAV in children include bedwetting, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.
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.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the goal date for an FDA decision on the sNDA submission and the potential timing of the availability of Xywav for people with idiopathic hypersomnia; and other statements that are not historical facts. These forward-looking statements are based on
- 2015 Review article in Chest, by Khan/Trotti et al, "Central Disorders of Hypersomnolence: Focus on the Narcolepsies and Idiopathic Hypersomnia" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4694150/
- 2016 Sleep Medicine Review article, by Billiard/Sonka et al, "Idiopathic Hypersomnia" https://www.ncbi.nlm.nih.gov/pubmed/26599679
- International Classification of Sleep Disorders, Third Edition (ICSD 3): http://www.aasmnet.org/store/product.aspx?pid=849
- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) p. 368-372 Hypersomnolence Disorder: https://www.psychiatry.org/psychiatrists/practice/dsm
- G Hess, R Mehra, G Carls, J Profant, J Altenburger, O Pasenchenko, J F Acquavella, 0625 US Prevalence of Narcolepsy and Other Sleep Disorders From 2013–2016: A Retrospective, Epidemiological Study Utilizing Nationwide Claims, Sleep, Volume 41, Issue suppl_1,
April 2018, Page A232, https://doi.org/10.1093/sleep/zsy061.624
- Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution Prescribing Information.
Palo Alto, CA: Jazz Pharmaceuticals, Inc.
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