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First presentation of the Phase 4 XYLO switch study reports blood pressure reductions in patients with narcolepsy when switching from twice-nightly high- to low-sodium oxybate

Novel intermediate analysis from the DUET trial cohort of patients taking >9 grams evaluated safety and changes in daytime sleepiness in adults with narcolepsy taking Xywav听dosages of 9-12 grams per night听

For U.S. media and investors only

DUBLIN, June 9, 2025 /PRNewswire/ -- Jazz听Pharmaceuticals听plc听(Nasdaq:听JAZZ) today听announced late-breaking Phase 4听data evaluating treatment benefits of Xywav^庐听(calcium, magnesium, potassium, and sodium oxybates) oral solution in people with narcolepsy. These results are two of Jazz's four late-breaking abstracts presented today as oral presentations at SLEEP 2025. The four late-breaking abstracts, selected for their scientific quality and innovation, comprise all industry-sponsored late-breaking oral presentations selected by the Associated Professional Sleep Societies (APSS). Xywav听is the only low-sodium oxybate approved by the听U.S. Food and Drug Administration听for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia. The Xywav label recommends a nightly dose of 6-9 grams per night.

"People living with narcolepsy have an increased risk of developing cardiovascular and cardiometabolic comorbidities," said Richard J. Kovacs, MD, MACC, Chief Medical Officer, American College of Cardiology and Q.E. and Sally Russell Professor of Cardiology, Indiana University School of Medicine, and XYLO Steering Committee member. "Results from the XYLO study reinforce the importance of monitoring cardiovascular indicators, including blood pressure, and the need to minimize exposure to excess sodium in this at-risk population. Reducing cardiovascular risk and disease is an important goal for all healthcare providers."

"People with narcolepsy live with a complex, severe disorder and often must combat excessive daytime sleepiness and associated symptoms 鈥� but the challenges they face are not only limited to sleep," said Kelvin Tan, MB BCh, MRCPCH, chief medical affairs officer of Jazz Pharmaceuticals. "Results from the XYLO interim analysis add to the overwhelming body of evidence demonstrating the positive implications of limiting unnecessary sodium intake, and emphasize how choosing low-sodium oxybate, Xywav, rather than twice-nightly high-sodium oxybate helps reduce excessive sodium burden, a modifiable risk factor for cardiovascular disease, in people with narcolepsy."

Phase 4 XYLO Results Show Impact of Switching from Twice-Nightly High- to Low-Sodium Oxybate on Ambulatory Blood Pressure in People with Narcolepsy
The open-label, single arm Phase 4 XYLO switch trial (n=43) met its primary endpoint of change in mean 24-hour ambulatory systolic blood pressure (SBP) from baseline (taking twice-nightly high-sodium oxybate) to end-of-treatment (after six weeks on low-sodium oxybate, Xywav), with a 鈭�4.1 (鈭�6.9, 鈭�1.4; P=0.0019) mmHg change. These results show that switching from twice-nightly high-sodium oxybate to the same dosage of low-sodium oxybate, Xywav, for approximately 6 weeks reduced daily treatment-related sodium intake and was associated with clinically meaningful blood pressure reductions in participants with narcolepsy, which was paralleled by 24-hour urinary sodium reduction. XYLO results are consistent with the extensive body of evidence on the benefits of reducing sodium intake.

The study also achieved key secondary endpoints, including mean change in ambulatory daytime SBP (-5.1 mmHg; P=0.0003) and mean change in seated resting (in-office) SBP (-9.2 mmHg; (P<0.0001). 听The change in mean nighttime ambulatory SBP was 鈭�2.0 (P=0.1265) mmHg. Exploratory endpoints evaluated change in 24-hour, daytime ambulatory, seated resting, and nighttime ambulatory diastolic blood pressure.

Overall, treatment-emergent adverse events (TEAEs) occurred in 32.8% of participants and were all mild or moderate in severity and consistent with the known safety profile of Xywav.

Phase 4 DUET Data Evaluated Effectiveness and Safety of Xywav in Adults with Narcolepsy Taking Dosages of 9-12 Grams
This intermediate analysis, which evaluates a cohort of adults with narcolepsy from the DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, demonstrated improvements in EDS on the Epworth Sleepiness Scale, the study's primary endpoint, in 24 participants taking 9-12 grams of Xywav twice-nightly, as compared to 9 grams at baseline. The current recommended dosage of Xywav for adults with narcolepsy is 6-9 grams per night. Following dose optimization, the average Xywav dose during the stable-dose period was 11.2 g/night.

Participants with narcolepsy in this intermediate cohort analysis also experienced improvements on the Narcolepsy Severity Scale. Additionally, participants showed minimal changes in the number of central apnea events, mean oxygen saturation (SpO2) levels, or the mean percent of total sleep time with SpO2 <90% from BL to EOT.

The DUET trial is a Phase 4, prospective, single-arm, open-label study to assess the effect of Xywav treatment on EDS, polysomnography parameters, and functional outcomes in adults with narcolepsy or IH. Overall, TEAEs were all mild or moderate and consistent with the known safety profile of Xywav at lower dosages.

The full abstracts will be available online at .

About Narcolepsy
Narcolepsy is a chronic, debilitating neurologic sleep disorder characterized by the inability to maintain continuous sleep at night and sustained wakefulness throughout the day. This leads to symptoms that can include fragmented or disrupted nighttime sleep, excessive daytime sleepiness, and cataplexy.¹ Patients with EDS due to narcolepsy experience sleep attacks, called cataplexy, and, despite fighting the urge to sleep, may unintentionally fall asleep for short periods.^2,3听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听Patients with narcolepsy are at increased risk for听hypertension, cardiometabolic morbidity,听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 Xywav^庐听(calcium, magnesium, potassium, and sodium oxybates) oral solution
Xywav听is the only low-sodium oxybate approved by the听U.S. Food and Drug Administration听(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听Xywav听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听Xywav听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^庐听(sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that听Xywav听provides a greatly reduced chronic sodium burden compared to听Xyrem.听Xywav听has 131 mg of sodium at the maximum recommended nightly dose听whereas other high sodium oxybates have 1640 mg at the equivalent dose.听Xywav听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 at the recommended dose range of 6 g to 9 g/night.听Xywav听is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake.

Xywav听is also the first and only听U.S.听FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for听Xywav听for the treatment of idiopathic hypersomnia in adults.听Xywav听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.听Xywav听can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.

The exact mechanism of action of听Xywav听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听Xywav听are mediated through GABA_B听actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.¹⁰听The听U.S.听Drug Enforcement Agency听(DEA) has designated听Xywav听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.^10,11听Because of the risks of central nervous system (CNS) depression and abuse and misuse,听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

Contraindications
XYWAV听is听contraindicated

• in combination with sedative hypnotics or alcohol and
• in patients with听succinic听semialdehyde听dehydrogenase听deficiency.

Warnings and Precautions
Central Nervous System Depression
The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYWAV should be considered.

After听first initiating treatment听and until certain that听XYWAV听does not affect听them听adversely (eg, impair听judgment, thinking,听or motor skills), caution听patients against听hazardous听activities听requiring complete听mental alertness听or motor听coordination听such as operating听hazardous听machinery, including听automobiles听or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking听XYWAV. Patients听should be queried听about CNS depression-related events听upon initiation听of XYWAV therapy听and听periodically听thereafter.

Abuse and Misuse
XYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as听gamma-hydroxybutyrate (GHB), a Schedule听I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of听GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.

XYWAV听and听XYREM听REMS
Because of the risks of central nervous system depression and abuse and misuse,听XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS.

Notable听requirements听of听the听XYWAV听and听XYREM听REMS听include the听following:

• Healthcare Providers who prescribe听XYWAV听are听specially certified
• XYWAV听will听be听dispensed听only听by听the听central听pharmacy that听is听specially听certified
• XYWAV听will be dispensed听and shipped听only to patients听who are enrolled in the XYWAV and听XYREM听REMS听with听documentation听of听safe听use

Further听information听is available听at听 or听1-866-997-3688.

Respiratory Depression and Sleep-Disordered Breathing
XYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In听overdoses听of oxybate听and听with illicit听use of GHB, life-threatening respiratory depression听has been听reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and听pediatric听patients. A significant increase听in the听number听of central apneas听and clinically significant听oxygen听desaturation听may occur听in patients with obstructive听sleep apnea听treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy.

Depression and听Suicidality
In Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression and depressed mood were reported in 3% and 4%, respectively, of patients treated with XYWAV. Two patients (1%) discontinued XYWAV because of depression. In most cases, no change in XYWAV treatment was required.听

In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment.

Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergence听of听depression听in patients treated听with XYWAV requires careful and immediate听evaluation. Monitor patients for the emergence of increased听depressive听symptoms and/or suicidality听while听taking听XYWAV.

Other Behavioral or Psychiatric Adverse Reactions
In听Study 1,听confusion and anxiety听occurred听in听1% and 5% of听patients with narcolepsy听treated听with 听听XYWAV, respectively. One patient听experienced听visual听hallucinations and confusion听after听ingesting approximately听9听grams听of XYWAV.

In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively.听One patient experienced visual hallucinations, which led to discontinuation of XYWAV.听

Other听neuropsychiatric听reactions reported听with oxybate听(same听active听moiety as XYWAV)听in adult or pediatric clinical听trials听and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored.

Parasomnias
Parasomnias听can听occur听in听patients听taking听XYWAV.

In Study 1 and Study 2,听parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with听XYWAV, respectively.听

In听a听clinical trial听of听XYREM听(same听active moiety听as听XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate听(same听active听moiety听as听XYWAV) and听in听postmarketing听experience听with听sodium听oxybate.

Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.

Most Common Adverse Reactions
The听most听common adverse听reactions (occurring in 鈮�5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache,听dizziness, anxiety, insomnia, decreased appetite,听hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.听

In the pediatric clinical trial with XYREM (same active moiety as XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (鈮�5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program. The safety profile in pediatric patients with XYWAV is expected to be similar to that of adult patients treated with XYWAV and to that of pediatric patients treated with XYREM.

Additional Adverse Reactions
Adverse reactions that occurred in 2-<5% of adult patients treated with XYWAV in the Open Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms. Adverse reactions occurring in 2-<5% of patients treated with XYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia, snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability.

Adverse reactions that occurred in听鈮�2% of patients in clinical studies with oxybate (but not in听Study听1)听and听which听may听be听relevant for听XYWAV, were pain, feeling drunk, pain in extremity, cataplexy, disturbance in attention, sleep paralysis, and disorientation.

Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%). In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DB听RWP) (up to 42听weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreased听appetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability). The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.

In the pediatric clinical trial with XYREM (same active moiety as XYWAV), 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache).

Drug Interactions
XYWAV is contraindicated in combination with alcohol or sedative hypnotics. Use of other CNS depressants听may听potentiate听the听CNS-depressant听effects of听XYWAV.

Concomitant听use of sodium听oxybate with divalproex听sodium听results in an increase in systemic听exposure to听GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. A similar increase in exposure is expected with concomitant use of听XYWAV and divalproex听sodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly with听divalproex听sodium. Prescribers听are advised听to monitor听patient听response closely and adjust dose accordingly听if听concomitant听use听of听XYWAV听and听divalproex sodium听is听warranted.

Pregnancy and Lactation
There are no adequate data on the developmental risk associated with the use of XYWAV or sodium听oxybate听in pregnant women. XYWAV should be used during pregnancy听only if the potential benefit听justifies听the听potential听risk听to听the听fetus.听GHB is excreted in human milk after oral administration of sodium听oxybate.听There is insufficient听information听on the risk to a breastfed infant, and there is insufficient听information听on milk听production听in nursing听mothers.听The听developmental听and听health听benefits of听breastfeeding should be听considered along with the mother's clinical need for XYWAV and any potential adverse effects on the breastfed infant听from XYWAV or听from听the听underlying maternal听condition.

Pediatric Use
The safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy or IH. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers.

Safety听and听effectiveness听of听XYWAV in听pediatric听patients below听the听age听of听7听years听with narcolepsy have听not听been听established.

Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established.

Geriatric Use
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Impairment
The听starting听dose听of听XYWAV should听be听reduced听in听patients听with听liver听impairment.

Dosage Modification in Patients with Hepatic Impairment:听The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.

Dependence and Tolerance
There听have听been听case听reports听of听withdrawal,听ranging听from听mild听to听severe,听following听discontinuation听of听illicit use of GHB听at frequent听repeated听doses听(18听g to 250 g per day)听in excess听of the recommended听dosage range. Signs and symptoms听of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required.

In the clinical trial experience听with听XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the听XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses,听one patient听reported insomnia听following听abrupt听discontinuation听of听XYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV.

Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen.

Please see full Prescribing Information, including BOXED Warning here:

About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases 鈥� 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听Dublin, Ireland听with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.

Contacts:

Media:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
[email protected]听
Ireland +353 1 637 2141
U.S. +1 215 867 4948

Investors:
Jeff Macdonald
Executive Director, Investor Relations
Jazz Pharmaceuticals plc
[email protected]
Ireland +353 1 634 3211
U.S. +1 650 496 2717

References:

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5. National Health Service. Narcolepsy 鈥� Overview. 2019.听https://www.nhs.uk/conditions/narcolepsy/. Accessed June 2025.
6. Ben-Joseph听RH, Saad R, Black J, et al. Cardiovascular burden of narcolepsy disease (CV-BOND): a real-world evidence study. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Poster 1203.
7. Black J,听Reaven NL, Funk SE, et al. Medical comorbidity in narcolepsy: findings from the Burden of Narcolepsy Disease (BOND) study. Sleep Med. 2017;33:13-18.
8. Ohayon MM, Black J, Lai C, et al. Increased mortality in narcolepsy. Sleep. 2014;37(3):439-444.
9. Ohayon MM. Narcolepsy is complicated by high medical and psychiatric comorbidities: a comparison with the general population. Sleep Med. 2013;14(6):488-492.
10. Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution. Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2021.
11. United States Drug Enforcement Agency. Drug Scheduling.听https://www.dea.gov/drug-information/drug-scheduling. Accessed June 2025.

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