Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act Litigation
Avadel Pharmaceuticals (Nasdaq: AVDL) announced a significant legal victory as the U.S. Court of Appeals for the District of Columbia Circuit unanimously affirmed the FDA's approval of LUMRYZ, their once-at-bedtime oxybate treatment for narcolepsy patients.
The Appeals Court's decision upholds a previous ruling by the U.S. District Court in favor of the FDA against Jazz Pharmaceuticals' challenge. The court specifically noted that LUMRYZ's once-at-bedtime dosing is clinically superior to all first-generation, immediate-release oxybates and provides a major contribution to patient care.
LUMRYZ, approved for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older, will continue to be available to patients. The company reports that thousands of patients are currently being treated with LUMRYZ, and they plan to expand access further through their commercial strategy.
Avadel Pharmaceuticals (Nasdaq: AVDL) ha annunciato una vittoria legale importante: la Corte d'Appello degli Stati Uniti per il Circuito del Distretto di Columbia ha confermato all'unanimità l'approvazione da parte della FDA di LUMRYZ, il loro trattamento con ossibato da assumere una volta a letto per i pazienti con narcolessia.
La decisione della Corte d'Appello conferma una sentenza precedente del Tribunale Distrettuale degli Stati Uniti a favore della FDA contro la contestazione di Jazz Pharmaceuticals. La corte ha sottolineato che la somministrazione di LUMRYZ una volta a letto è clinicamente superiore rispetto a tutti gli ossibati di prima generazione a rilascio immediato e rappresenta un contributo significativo per la cura dei pazienti.
LUMRYZ, approvato per il trattamento della cataplessia o dell’eccessiva sonnolenza diurna nei pazienti con narcolessia di età pari o superiore a 7 anni, continuerà ad essere disponibile ai pazienti. L'azienda riferisce che migliaia di pazienti sono attualmente in trattamento con LUMRYZ e prevede di ampliare ulteriormente l'accesso tramite la propria strategia commerciale.
Avadel Pharmaceuticals (Nasdaq: AVDL) anunció una importante victoria legal tras la confirmación unánime por parte del Tribunal de Apelaciones de EE.UU. para el Circuito del Distrito de Columbia de la aprobación de la FDA de LUMRYZ, su tratamiento con oxibato para tomar una vez al acostarse para pacientes con narcolepsia.
La decisión del Tribunal de Apelaciones ratifica una sentencia previa del Tribunal de Distrito de EE.UU. a favor de la FDA frente al desafío de Jazz Pharmaceuticals. El tribunal destacó que la dosificación de LUMRYZ una vez al acostarse es clínicamente superior a todos los oxibatos de primera generación de liberación inmediata y representa una contribución importante para el cuidado del paciente.
LUMRYZ, aprobado para tratar la cataplexia o la somnolencia diurna excesiva en pacientes con narcolepsia de 7 años en adelante, seguirá estando disponible para los pacientes. La compañía informa que miles de pacientes están siendo tratados actualmente con LUMRYZ y planean ampliar el acceso mediante su estrategia comercial.
Avadel Pharmaceuticals (나스닥: AVDL)는 미국 컬럼비아 지구 항소 법원이 FDA의 LUMRYZ 승인을 만장일치로 확정하며 중요한 법적 승리를 발표했습니다. LUMRYZ는 기면증 환자를 위한 취침 전 1회 복용 옥시베이트 치료제입니다.
항소 법원은 Jazz Pharmaceuticals의 이의를 기각하고 FDA의 손을 들어준 미국 지방법원의 이전 판결을 유지했습니다. 법원은 특히 LUMRYZ의 취침 전 1회 투여가 1세대 즉시 방출 옥시베이트보다 임상적으로 우수하다고 평가하며 환자 치료에 큰 기여를 한다고 밝혔습니다.
7세 이상 기면증 환자의 탈력발작 또는 과도한 주간 졸림증 치료에 승인된 LUMRYZ는 앞으로도 환자들에게 제공될 예정입니다. 회사는 현재 수천 명의 환자가 LUMRYZ로 치료받고 있다고 보고하며 상업 전략을 통해 접근성을 더욱 확대할 계획입니다.
Avadel Pharmaceuticals (Nasdaq : AVDL) a annoncé une victoire juridique majeure : la Cour d'appel des États-Unis pour le Circuit du District de Columbia a confirmé à l'unanimité l'approbation par la FDA de LUMRYZ, leur traitement à base d'oxybate à prendre une fois au coucher pour les patients atteints de narcolepsie.
La décision de la Cour d'appel confirme un jugement antérieur du tribunal de district américain en faveur de la FDA face au recours de Jazz Pharmaceuticals. La cour a souligné que la posologie unique au coucher de LUMRYZ est cliniquement supérieure à tous les oxybates de première génération à libération immédiate et constitue une contribution majeure aux soins des patients.
LUMRYZ, approuvé pour traiter la cataplexie ou l'hypersomnie diurne excessive chez les patients narcoleptiques âgés de 7 ans et plus, restera disponible pour les patients. La société indique que des milliers de patients sont actuellement traités avec LUMRYZ et prévoit d'élargir l'accès grâce à sa stratégie commerciale.
Avadel Pharmaceuticals (Nasdaq: AVDL) gab einen bedeutenden rechtlichen Erfolg bekannt: Das US-Berufungsgericht für den District of Columbia Circuit bestätigte einstimmig die Zulassung von LUMRYZ durch die FDA, ihrem einmal-pro-Schlafenszeit-Oxybat-Medikament für Patienten mit Narkolepsie.
Die Entscheidung des Berufungsgerichts bestätigt eine frühere Entscheidung des US-Bezirksgerichts zugunsten der FDA gegen die Anfechtung durch Jazz Pharmaceuticals. Das Gericht stellte ausdrücklich fest, dass die einmalige Einnahme von LUMRYZ vor dem Schlafengehen klinisch überlegen gegenüber allen Oxybaten der ersten Generation mit sofortiger Freisetzung ist und einen bedeutenden Beitrag zur Patientenversorgung leistet.
LUMRYZ, zugelassen zur Behandlung von Kataplexie oder übermäßiger Tagesschläfrigkeit bei Narkolepsie-Patienten ab 7 Jahren, wird weiterhin für Patienten verfügbar sein. Das Unternehmen berichtet, dass derzeit Tausende von Patienten mit LUMRYZ behandelt werden und plant, den Zugang durch seine kommerzielle Strategie weiter auszubauen.
- Unanimous Appeals Court decision upholds FDA approval of LUMRYZ
- Court confirms LUMRYZ's clinical superiority to first-generation oxybate treatments
- Thousands of patients currently being treated with LUMRYZ
- Legal victory removes uncertainty around LUMRYZ's FDA approval
- Product offers unique once-at-bedtime dosing advantage
- None.
Insights
Appeals Court unanimously upholds LUMRYZ approval, removing legal risk and validating Avadel's once-nightly narcolepsy treatment against Jazz's challenge.
The U.S. Court of Appeals for the D.C. Circuit has delivered a significant legal victory for Avadel Pharmaceuticals by unanimously affirming the lower court's decision that upheld FDA's approval of LUMRYZ. This conclusively resolves the Administrative Procedure Act litigation brought by Jazz Pharmaceuticals, which had challenged the regulatory pathway for LUMRYZ's approval.
The ruling carries substantial implications for Avadel's market position. The Appeals Court specifically acknowledged the FDA's undisputed finding that LUMRYZ's once-at-bedtime dosing provides clinical superiority over first-generation immediate-release oxybates and makes a major contribution to patient care. This judicial affirmation of LUMRYZ's differentiation is particularly valuable for Avadel's competitive positioning in the narcolepsy treatment landscape.
This decision represents the culmination of a protracted legal battle that began with the District Court's ruling in October 2024, which granted summary judgment in favor of the FDA and Avadel while denying Jazz's motion. By exhausting Jazz's primary legal avenue for challenging LUMRYZ's approval, this Appeals Court decision removes a significant regulatory uncertainty that had been hanging over Avadel's commercial prospects. The unanimous nature of the ruling further strengthens its finality and reduces the likelihood of additional legal challenges.
With this litigation hurdle cleared, Avadel can now execute its commercial strategy with greater regulatory certainty, potentially accelerating market penetration for its novel once-nightly narcolepsy treatment.
DUBLIN, June 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the “Appeals Court”) affirmed a prior decision of the U.S. District Court for the District of Columbia (the “District Court”) in favor of the U.S. Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) regarding the FDA’s approval of LUMRYZTM, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
“The unanimous decision by the Appeals Court panel upholding the FDA’s approval of LUMRYZ underscores the importance of its innovative formulation and validates its benefits for people with narcolepsy,” said Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals. “The ruling affirms the FDA’s decision, which the Appeals Court noted was undisputed, that LUMRYZ’s once-at-bedtime dosing is clinically superior to all first generation, immediate-release oxybates and provides a major contribution to patient care.”
“Importantly, with this ruling, LUMRYZ will continue to be available for narcolepsy patients to consistently experience the benefits of a full, therapeutic, once-at-bedtime dose of oxybate therapy offering the potential for an uninterrupted night’s sleep. We will continue advancing our commercial strategy to ultimately transform the sleep treatment paradigm for the narcolepsy community and increase the number of patients well beyond the thousands currently treated with LUMRYZ,” continued Mr. Divis.
Following the District Court’s ruling in favor of the FDA and Avadel in October 2024, which granted the FDA’s Motions for Summary Judgment with respect to Jazz’s complaint and denied Jazz’s Motion for Summary Judgment, Jazz filed a notice of appeal to the Appeals Court. On June 27, 2025, the Appeals Court, in a unanimous panel decision, affirmed the District Court’s ruling and upheld the FDA’s approval of LUMRYZ.
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.
LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients 7 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 7 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 www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED Warning, and Medication Guide.
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; the potential benefits of the Appeals Court’s ruling; the Company’s strategy to transform the sleep treatment paradigm for the narcolepsy community; and the Company’s expectations to increase the number of patients treated with 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.
Investor Contact:
Austin Murtagh
Precision AQ
Austin.Murtagh@precisionaq.com
(212) 698-8696
Media Contact:
Lesley Stanley
Real Chemistry
lestanley@realchemistry.com
(609) 273-3162
FAQ
What was the outcome of Avadel's (AVDL) Appeals Court decision for LUMRYZ?
What makes LUMRYZ different from other narcolepsy treatments?
Who can be treated with Avadel's LUMRYZ?
How many patients are currently using Avadel's LUMRYZ?
What was Jazz Pharmaceuticals' role in the LUMRYZ court case?
