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

Rhea-AI Summary

Avadel Pharmaceuticals (AVDL) will present 14 abstracts, including 4 oral presentations, at SLEEP 2025 (June 8-11, Seattle) showcasing new data for LUMRYZ™, their once-nightly narcolepsy treatment. Key highlights include: - Interim REFRESH study results showing clinically significant efficacy in patients switching from twice-nightly to once-nightly oxybate - Post-hoc REST-ON trial analysis demonstrating improved Epworth Sleepiness Scale scores to normal levels in severely sleepy patients - Data showing LUMRYZ participants reported approximately 50% fewer hypnagogic/hypnopompic hallucination events versus placebo - Long-term RESTORE study results (median 503 days) showing only 4% discontinuation rate due to treatment-related adverse events - Evidence of improvement in sleep-related eating disorder (SRED) when switching from twice-nightly oxybates to LUMRYZ

– 14 abstracts accepted, including four oral presentations –

– Interim analysis of real-world REFRESH study demonstrated clinically significant efficacy and improvement of EDS for patients who switched from twice-nightly oxybate to once-at-bedtime LUMRYZ –

– Data reflecting the therapeutic results of LUMRYZ treatment in people with narcolepsy across clinical as well as real-world settings will be presented –

DUBLIN, Ireland, May 29, 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 and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 posters at SLEEP 2025, the 39^th Annual Meeting of the Associated Professional Sleep Societies (APSS), taking place June 8-11, 2025 in Seattle.

“Post-hoc analysis of the pivotal Phase 3 REST-ON clinical trial, restricted to those study participants with the most severe sleepiness at baseline as measured both objectively and subjectively, showed LUMRYZ participants with a median Epworth Sleepiness Scale (ESS) score at Week 13 that was improved to the range at or below that considered normal. Another post-hoc investigation analyzed the apnea-hypopnea index (AHI) for those with no or mild sleep apnea at baseline and provides reassuring data that the AHI was not worsened at any LUMRYZ dose,” said Richard Bogan, M.D., lead study author, Medical Director of SleepMed of South Carolina and Associate Clinical Professor at both the University of South Carolina School of Medicine and the Medical University of South Carolina. “In addition, and importantly, an interim analysis of narcolepsy patients in an open label switch study, REFRESH, from twice-nightly to once-nightly oxybate therapy, demonstrated clinically significant efficacy and improvement of excessive daytime sleepiness. The REFRESH study is an additional piece of evidence validating the efficacy of LUMRYZ in the treatment of excessive sleepiness and cataplexy in narcolepsy patients.”

Highlights from the presentations at SLEEP 2025 include:

• Interim REFRESH results demonstrating that among 67 patients (approximately half oxybate naïve, 37% switches from twice-nightly oxybates, and the remainder previous twice-nightly oxybate users); patients in all groups achieved clinically significant reductions in sleepiness, with normal ESS scores after starting LUMRYZ.
• A post-hoc analysis restricted to the most severely sleepy tertiles at baseline in REST-ON; at the end of the study, median ESS was at or below the normal threshold with LUMRYZ.
• A post-hoc analysis from REST-ON to quantify hypnagogic and hypnopompic hallucinations (HH) during the trial; these aggregate data show that LUMRYZ participants reported approximately half as many HH events where they felt like they were going to be attacked, flying through the air, or falling into a hole compared to placebo.
• A post-hoc analysis from REST-ON demonstrating consistency of LUMRYZ efficacy across objective and subjective disrupted nighttime sleep outcomes in various subgroups (e.g., narcolepsy type 1 or 2, male or female, stimulant use).
• A retrospective chart analysis of patients with sleep-related eating disorder (SRED) while on twice-nightly oxybates, which was ameliorated after switching to LUMRYZ.
• A post hoc analysis from the stable dosing period of the RESTORE open-label study evaluating 115 participants (median treatment: 503 days) who switched from twice-nightly oxybate to LUMRYZ; side effects were consistent with the known adverse events of oxybates and only 4% of participants discontinued LUMRYZ due to a treatment-related adverse event, underscoring the long-term tolerability of LUMRYZ.
• A survey conducted in collaboration with MyNarcolepsyTeam of 88 respondents, revealing the need for enhanced patient-clinician discussions of oxybates as a treatment option, as well as better setting of oxybate treatment expectations to minimize discontinuations, particularly as they relate to side effects that are generally transient in nature.
  

“We are thrilled with our strong scientific presence at SLEEP 2025 and the opportunity to further enhance awareness and understanding of the benefits that LUMRYZ offers to people living with narcolepsy,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel. “I am particularly excited that there will be data available on SRED, a phenomenon that has been shown to disproportionately impact people taking immediate-release, twice-nightly oxybate,¹ and which Dr. Lewis Kass describes in his practice as resolving when his patients transitioned to LUMRYZ. Additionally, our interim REFRESH data not only demonstrate efficacy, with patients achieving ESS scores in the normal range, they also further corroborate prior research of frequent missed middle-of-the-night doses with twice-nightly oxybates and diminished efficacy when this occurs.”^2,3

All abstracts were published in an online supplement in the journal Sleep. Presentation details are as follows:

Title	Presentation Details
Wednesday, June 11 – Oral Presentations
Effects of Once-Nightly Sodium Oxybate on Apnea-Hypopnea Index: Post Hoc Analysis from the Phase 3 REST-ON Clinical Trial	Session: O-24 (also presented as poster #389) Time: 3:30-3:45 p.m. PT
Clinically Meaningful Improvement in Daytime Sleepiness with ON-SXB in People with Narcolepsy and Severe Sleepiness	Session: O-24 (also presented as poster #394) Time: 4:45-5:00 p.m. PT
Long-Term Safety and Tolerability of Once-Nightly Sodium Oxybate: A Post Hoc Analysis from RESTORE	Session: O-24 (also presented as poster #395) Time: 5:00-5:15 p.m. PT
Hypnagogic/Hypnopompic Hallucination Types Among Participants with Narcolepsy Type 1 from the Phase 3 REST-ON Trial	Session: O-24 (also presented as poster #396) Time: 5:15-5:30 p.m. PT
Wednesday, June 11 – Poster Presentations
Effect of Narcolepsy and Idiopathic Hypersomnia on Relationships: A Social Media Analysis	Session: P-51 Poster Number: 327 Time: 10:00-10:45 a.m. PT
Effects of Once-Nightly Sodium Oxybate on Apnea-Hypopnea Index: Post Hoc Analysis from the Phase 3 REST-ON Clinical Trial	Session: P-51 Poster Number: 389 (also oral presentation, as noted above) Time: 10:00-10:45 a.m. PT
Long-Term Safety and Tolerability of Once-Nightly Sodium Oxybate: A Post Hoc Analysis from RESTORE	Session: P-51 Poster Number: 395 (also oral presentation, as noted above) Time: 10:00-10:45 a.m. PT
Improvement of Individual Excessive Daytime Sleepiness Symptoms with Once-Nightly Sodium Oxybate for Narcolepsy	Session: P-51 Poster Number: 397 Time: 10:00-10:45 a.m. PT
Understanding Path to Diagnosis, Healthcare Provider Relationships, and Treatment Regimens Among People Living with Narcolepsy	Session: P-51 Poster Number: 401 Time: 10:00-10:45 a.m. PT
Successful Transition from Twice-Nightly Oxybates to Once-Nightly Sodium Oxybate: A Post Hoc Analysis from RESTORE	Session: P-51 Poster Number: 417 Time: 10:00-10:45 a.m. PT
REFRESH: A Prospective, Observational Study of Once-Nightly Sodium Oxybate Used in Clinical Practice for the Treatment of Narcolepsy	Session: P-51 Poster Number:419 Time: 10:00-10:45 a.m. PT
Correlation Between Mean Sleep Latency on the Maintenance of Wakefulness Test and Epworth Sleepiness Scale in REST-ON	Session: P-51 Poster Number: 421 Time: 10:00-10:45 a.m. PT
Clinically Meaningful Improvement in Daytime Sleepiness with ON-SXB in People with Narcolepsy and Severe Sleepiness	Session: P-51 Poster Number: 394 (also oral presentation, as noted above) Time: 11:00-11:45 a.m. PT
Hypnagogic/Hypnopompic Hallucination Types Among Participants with Narcolepsy Type 1 from the Phase 3 REST-ON Trial	Session: P-51 Poster Number: 396 (also oral presentation, as noted above) Time: 11:00-11:45 a.m. PT
Consistent Efficacy of Once-Nightly Sodium Oxybate on Disrupted Nighttime Sleep in People with Narcolepsy	Session: P-51 Poster Number: 398 Time: 11:00-11:45am PT
Oxybate Awareness, Usage, and Experience Among People with Narcolepsy: A MyNarcolepsyTeam Survey Analysis	Session: P-51 Poster Number: 402 Time: 11:00-11:45 a.m. PT
Improvement in Sleep-Related Eating Disorder After Switching from Twice- to Once-Nightly Oxybate	Session: P-51 Poster Number: 404 Time: 11:00-11:45 a.m. PT
Safety of Once-Nightly Sodium Oxybate in Subgroups of the Long-Term RESTORE Study	Session: P-51 Poster Number: 416 Time: 11:00-11:45 a.m. PT

Additionally, Avadel will host a product theater for U.S. healthcare professionals titled, “Avadel Roundtable: A Multidisciplinary Narcolepsy Care Approach,” Tuesday, June 10, from 11:45 a.m. to 12:45 p.m. PT at the Sheraton Grand Seattle, Grand Ballroom C. The symposium will feature Alon Y. Avidan, M.D., M.P.H., Professor of Neurology at the David Geffen School of Medicine at UCLA and Director of the UCLA Sleep Disorders Center; Monique Mulvany, N.P., a family nurse practitioner specializing in sleep disorders at Sleep Medicine Consultants in Austin, Texas; and a person living with narcolepsy. Interested attendees can register at www.AvadelProductTheater.com.

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 7 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 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients 7 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.

INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years 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 the efficacy and potential therapeutic benefit of LUMRYZ; expectations regarding the results from post-hoc analyses of the Company’s clinical trials, including LUMRYZ’s impact on AHI and SRED; and expectations regarding the success of the commercialization of LUMRYZ. 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.

Media Contact:
Lesley Stanley
Real Chemistry
lestanley@realchemistry.com

Investor Contact:
Austin Murtagh
Precision AQ
Austin.Murtagh@precisionAQ.com   

References
1. Merino D, Gerard AO, Van Obberghen EK, et al. Medications as a trigger of sleep-related eating disorder: a disproportionality analysis. J Clin Med. 2022; 11(13):3890. doi:10.3390/jcm11133890
2. Roy A, Stern T, Harsh J, et al. RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates. Sleep Med X. 2024;8:1-7. doi:10.1016/j.sleepx.2024.100122
3. Picone M, Ascencion F, Horsnell M, et al. Understanding the patient experience with twice-nightly sodium oxybate therapy for narcolepsy: a social listening experiment. Brain Sciences. 2024;14(12). doi:10.3390/brainsci14121189

FAQ

What new data will AVDL present about LUMRYZ at SLEEP 2025?

Avadel will present 14 abstracts including 4 oral presentations showing LUMRYZ's efficacy in treating narcolepsy, improved sleepiness scores, reduced hallucinations, and positive long-term safety data from the RESTORE study.

What were the key findings from the REFRESH study for LUMRYZ?

The interim REFRESH study showed that patients who switched from twice-nightly to once-nightly LUMRYZ achieved clinically significant reductions in sleepiness, with normal ESS scores after starting treatment.

How did LUMRYZ affect hallucinations in narcolepsy patients?

LUMRYZ participants reported approximately 50% fewer hypnagogic and hypnopompic hallucination events compared to placebo, particularly events where they felt like being attacked, flying, or falling.

What were the long-term safety results for LUMRYZ in the RESTORE study?

The RESTORE study of 115 participants over a median of 503 days showed good long-term tolerability, with only 4% discontinuing due to treatment-related adverse events.

How did LUMRYZ affect patients with sleep-related eating disorder (SRED)?

A retrospective chart analysis showed that SRED symptoms, which occurred while patients were on twice-nightly oxybates, improved after switching to once-nightly LUMRYZ.