Avadel Pharmaceuticals to Present New Data on LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension at World Sleep 2025

– 17 abstracts accepted, including one oral presentation –

– Data from the REFRESH real-world study highlight efficacy of once-nightly sodium oxybate when switching from twice-nightly oxybates –

– REFRESH study also highlights efficacy in those who were new to oxybate or returning to oxybate after discontinuing twice-nightly oxybate –

DUBLIN, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16 posters at World Sleep 2025, taking place September 5-10, in Singapore.

"LUMRYZ's novel once-nightly delivery system means patients do not have to worry about not waking up and missing their second dose. The single bedtime dose helps assure patients receive the full therapeutic benefit of their medication every night, demonstrated in the REFRESH study to result in clinically meaningful outcomes for both switch and naïve oxybate patients,” said Gerard J. Meskill, MD, CEO of Tricoastal Narcolepsy and Sleep Disorders Center. “It also means their partners don't have to wake up to an alarm, which is a forgotten burden of this disease and can be a source of guilt for patients."

Additional highlights from the presentations at World Sleep 2025 include:

Updated and new results from an interim descriptive analysis of data from REFRESH (n=51), a prospective multicenter, real-world study in patients with narcolepsy, including those who switched to LUMRYZ from twice-nightly and those new to oxybate or returning to oxybate after discontinuing twice-nightly oxybate.
- Results showed that participants experienced clinically meaningful improvements in Epworth Sleepiness Scale (ESS) scores, a measure of excessive daytime sleepiness (EDS), to within the normal range.
- REFRESH study participants experienced a reduction in severity from moderate at the start of the study to mild at study end for the pentad of narcolepsy symptoms measured on the Narcolepsy Severity Scale (NSS) and reduced interference across domains on the Sheehan Disability Scale (SDS).
- After completing 4 months of therapy (switch participants, n=20; non-switch, n=31), 70% and 76% of switch participants and 90% and 87% of non-switch participants were improved on the Patient Global Impression of Change and the Clinician Global Impression of Change, respectively.
- Additional interim results from a study questionnaire and end of study survey showed that overall quality of life, fatigue, brain fog, depression, anxiety, and mood improved and as-needed use of stimulants was reduced.
To characterize the comorbidities of patients with narcolepsy, an analysis of aggregate patient data from electronic health records (EHR) was conducted at Duke University. Results from 1,659 patients with narcolepsy and 1,659 matched controls showed sleep, pain and psychiatric or mood disorders occurred significantly more frequently in patients with narcolepsy versus the control group (all p<0.0001); hypertension and cardiovascular disease were not included in the top 23 comorbidities identified to be increased.

“Presentations at this year’s World Sleep congress reinforce the benefits of LUMRYZ, including improvements in the hallmark symptoms of EDS, disrupted nighttime sleep, and sleep-related hallucinations,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel. “In particular, the emerging data from the REFRESH study provide further evidence of symptom improvement with LUMRYZ. While the magnitude of change was greatest for those not on an oxybate at study entry, meaningful improvements were also observed in the twice-nightly oxybate switch cohort showing additional clinical benefit that can be gained by consistently taking a single, full therapeutic dose of oxybate at bedtime.”

Oral and poster presentation details follow. All times are in Singapore Time (SGT), and all poster presentations take place in Hall 405:

Tuesday, September 9 – Oral Presentation
Clinically Meaningful Improvement in Daytime Sleepiness With ON-SXB in People With Narcolepsy and Severe Sleepiness	Session: O-17: Biomarkers, phenotyping, and cognitive aspects in narcolepsy and hypersomnolence Abstract Number: 170 Time: 9:00-10:30 a.m. SGT Location: Room 327
Sunday, September 7 – Poster Presentations
Effects of Once-Nightly Sodium Oxybate on Apnea-Hypopnea Index: Post Hoc Analysis From the Phase 3 REST-ON Clinical Trial	Session: Poster abstract group 1 Poster Number: 201 Time: 5:00-6:00 p.m. SGT
Monday, September 8 – Poster Presentations
Effect of Narcolepsy and Idiopathic Hypersomnia on Relationships: A Social Media Analysis	Session: Poster abstract group 2 Poster Number: 193 Time: 6:30-7:30 p.m.
Assessing Usability of Once-Nightly Sodium Oxybate Extended-Release Oral Suspension for Narcolepsy	Session: Poster abstract group 2 Poster Number: 198 Time: 6:30-7:30 p.m. SGT
Demographics and Comorbidities of Patients With Narcolepsy: A Propensity Score-Matched Cohort Study	Session: Poster abstract group 2 Poster Number: 202 Time: 6:30-7:30 p.m. SGT
Amelioration of Sleep-Related Eating Disorder After Switching From Twice- to Once-Nightly Oxybate	Session: Poster abstract group 2 Poster Number: 203 Time: 6:30-7:30 p.m. SGT
Once-Nightly Sodium Oxybate Improves Narcolepsy Symptoms in People With Narcolepsy: Interim Results from the Real-World REFRESH Study	Session: Poster abstract group 2 Poster Number: 211 Time: 6:30-7:30 p.m. SGT
Successful Transition From Twice-Nightly Oxybates to Once-Nightly Sodium Oxybate: A Post Hoc Analysis From RESTORE	Session: Poster abstract group 2 Poster Number: 213 Time: 6:30-7:30 p.m. SGT
Tuesday, September 9 – Poster Presentations
Safety and Tolerability of Once-Nightly Sodium Oxybate: A Post Hoc Analysis From the Long-Term RESTORE Study	Session: Poster abstract group 3 Poster Number: 168 Time: 4:45-5:45 pm. SGT
Understanding Path to Diagnosis, HCP Relationships, and Treatment Regimens Among People Living with Narcolepsy	Session: Poster abstract group 3 Poster Number: 178 Time: 4:45-5:45 p.m.
Hypnagogic/Hypnopompic Hallucination Types Among Participants With Narcolepsy Type 1 From the Phase 3 REST-ON Trial	Session: Poster abstract group 3 Poster Number: 179 Time: 4:45-5:45 p.m. SGT
Oxybate Awareness, Usage, and Experience Among People With Narcolepsy: A MyNarcolepsyTeam Survey Analysis	Session: Poster abstract group 3 Poster Number: 181 Time: 4:45-5:45 p.m. SGT
Real-World Experience of Once-Nightly Sodium Oxybate Treatment in People With Narcolepsy: Interim Results from REFRESH	Session: Poster abstract group 3 Poster Number: 183 Time: 4:45-5:45 p.m. SGT
Long-Term Safety and Tolerability of Once-Nightly Sodium Oxybate: A Post Hoc Analysis From RESTORE	Session: Poster abstract group 3 Poster Number: 185 Time: 4:45-5:45 p.m. SGT
Correlation Between Maintenance of Wakefulness Test and Epworth Sleepiness Scale Scores in REST-ON	Session: Poster abstract group 3 Poster Number: 188 Time: 4:45-5:45 p.m. SGT
Consistent Efficacy of Once-Nightly Sodium Oxybate on Disrupted Nighttime Sleep in People with Narcolepsy	Session: Poster abstract group 3 Poster Number: 193 Time: 4:45-5:45 p.m. SGT

About LUMRYZ™ (sodium oxybate) for extended-release oral suspension
LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients seven years of age and older with narcolepsy.

The FDA approval of LUMRYZ was supported by results from REST-ON™, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.

With its approvals in May 2023 and October 2024, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients seven years of age and older with narcolepsy respectively due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.

LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy, and Avadel does not sell LUMRYZ for any indication beyond narcolepsy.

INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients seven years of age and older with narcolepsy:

sudden onset of weak or paralyzed muscles (cataplexy)
excessive daytime sleepiness (EDS)

IMPORTANT SAFETY INFORMATION

WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you 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 LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have 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 have any of these serious side effects.

Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029.

Do not take LUMRYZ 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 LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Anyone who takes LUMRYZ 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 six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.

Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.

LUMRYZ can cause serious side effects, including the following:

Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.
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 and difficulty concentrating. 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 or your child have 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 start sleepwalking.

Tell your doctor if you or your child are on a salt-restricted diet or have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.

The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.

LUMRYZ 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 LUMRYZ.

For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including BOXED Warning.

About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. For more information, please visit www.avadel.com.

Avadel intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcast.

Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding efficacy and therapeutic benefits of LUMRYZ; the potential benefits of a once-nightly delivery system; and expectations regarding the results and implications of the REFRESH study. In some cases, forward-looking statements can be identified by use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable).

The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Investor Contact:
Austin Murtagh
Precision AQ
Austin.Murtagh@precisionAQ.com
(212) 698-8696

Media Contact:
Alyssa Ramirez
Real Chemistry
aramirez@realchemistry.com

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