Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court Injunction
The United States Court of Appeals for the Federal Circuit has ruled in Avadel Pharmaceuticals' (NASDAQ: AVDL) favor, overturning key portions of a Delaware Court injunction regarding LUMRYZ™. The Federal Circuit vacated restrictions that previously prevented Avadel from seeking FDA approval for LUMRYZ beyond narcolepsy treatment. The ruling also lifts prohibitions on conducting new clinical trials and offering open-label extensions to trial participants.
The company's REVITALYZ™ Phase 3 trial for Idiopathic Hypersomnia (IH) remains on schedule, with patient enrollment expected to complete by end of 2025. This double-blind, placebo-controlled study will evaluate LUMRYZ's efficacy and safety in approximately 150 adult IH patients, including those switching from immediate-release oxybates and new participants.
La Corte d'Appello degli Stati Uniti per il Circuito Federale ha emesso una sentenza a favore di Avadel Pharmaceuticals (NASDAQ: AVDL), annullando parti fondamentali di un'ingiunzione del tribunale del Delaware relativa a LUMRYZ™. Il Circuito Federale ha revocato le restrizioni che impedivano ad Avadel di richiedere l'approvazione della FDA per LUMRYZ oltre il trattamento della narcolessia. La sentenza elimina anche i divieti di condurre nuovi studi clinici e di offrire estensioni open-label ai partecipanti agli studi.
Il trial di Fase 3 di REVITALYZ™ per l'Ipersonnia Idiopatica (IH) procede secondo i tempi previsti, con la conclusione dell'arruolamento dei pazienti prevista entro la fine del 2025. Questo studio in doppio cieco, controllato con placebo, valuterà l'efficacia e la sicurezza di LUMRYZ in circa 150 pazienti adulti con IH, inclusi quelli che passeranno dagli ossibati a rilascio immediato e nuovi partecipanti.
El Tribunal de Apelaciones de los Estados Unidos para el Circuito Federal falló a favor de Avadel Pharmaceuticals (NASDAQ: AVDL), revocando partes clave de una orden judicial del tribunal de Delaware relacionada con LUMRYZ™. El Circuito Federal anuló las restricciones que anteriormente impedían a Avadel solicitar la aprobación de la FDA para LUMRYZ más allá del tratamiento de la narcolepsia. La sentencia también elimina las prohibiciones para realizar nuevos ensayos clínicos y ofrecer extensiones de etiqueta abierta a los participantes del estudio.
El ensayo de fase 3 de REVITALYZ™ para Hipersomnia Idiopática (IH) continúa según lo previsto, con la inscripción de pacientes que se espera finalice a finales de 2025. Este estudio doble ciego, controlado con placebo, evaluará la eficacia y seguridad de LUMRYZ en aproximadamente 150 pacientes adultos con IH, incluyendo aquellos que cambien de oxibatos de liberación inmediata y nuevos participantes.
미국 연방 순회항소법원은 Avadel Pharmaceuticals (NASDAQ: AVDL)에 유리한 판결을 내리며 델라웨어 법원의 LUMRYZ™ 관련 주요 금지 명령을 뒤집었습니다. 연방 순회법원은 Avadel이 나르콜렙시 치료 외에 LUMRYZ에 대해 FDA 승인을 신청하는 것을 막았던 제한 조치를 취소했습니다. 이번 판결로 새로운 임상시험 실시 및 시험 참가자에게 오픈라벨 연장 제공 금지도 해제되었습니다.
회사의 REVITALYZ™ 3상 임상시험은 특발성 과다수면증(IH) 치료를 위해 예정대로 진행 중이며, 환자 등록은 2025년 말까지 완료될 것으로 예상됩니다. 이중맹검 위약대조 연구로, 즉시 방출 옥시베이트를 전환하는 환자와 신규 참가자를 포함해 약 150명의 성인 IH 환자를 대상으로 LUMRYZ의 효능과 안전성을 평가할 예정입니다.
La Cour d'appel des États-Unis pour le circuit fédéral a statué en faveur de Avadel Pharmaceuticals (NASDAQ : AVDL), annulant des parties clés d'une injonction du tribunal du Delaware concernant LUMRYZ™. Le circuit fédéral a levé les restrictions qui empêchaient auparavant Avadel de demander l'approbation de la FDA pour LUMRYZ au-delà du traitement de la narcolepsie. La décision supprime également les interdictions de mener de nouveaux essais cliniques et d'offrir des prolongations en ouvert aux participants aux essais.
L'essai de phase 3 de REVITALYZ™ pour l'hypersomnie idiopathique (IH) suit son calendrier, avec un recrutement des patients prévu jusqu'à la fin de 2025. Cette étude en double aveugle, contrôlée par placebo, évaluera l'efficacité et la sécurité de LUMRYZ chez environ 150 patients adultes atteints d'IH, y compris ceux passant des oxybates à libération immédiate et les nouveaux participants.
Das Berufungsgericht der Vereinigten Staaten für den Bundeskreis hat zugunsten von Avadel Pharmaceuticals (NASDAQ: AVDL) entschieden und wesentliche Teile einer einstweiligen Verfügung des Delaware-Gerichts bezüglich LUMRYZ™ aufgehoben. Der Bundeskreis hob die Beschränkungen auf, die Avadel zuvor daran hinderten, eine FDA-Zulassung für LUMRYZ über die Behandlung von Narkolepsie hinaus zu beantragen. Das Urteil hebt auch Verbote für die Durchführung neuer klinischer Studien und die Angebotserweiterung für Studienteilnehmer auf.
Die Phase-3-Studie von REVITALYZ™ für idiopathische Hypersomnie (IH) verläuft planmäßig, wobei die Patientenaufnahme voraussichtlich bis Ende 2025 abgeschlossen sein wird. Diese doppelblinde, placebokontrollierte Studie wird die Wirksamkeit und Sicherheit von LUMRYZ bei etwa 150 erwachsenen IH-Patienten untersuchen, einschließlich solcher, die von sofort freisetzenden Oxybaten wechseln, sowie neuer Teilnehmer.
- Federal Circuit overturned key restrictions, allowing LUMRYZ development beyond narcolepsy
- Company can now seek FDA approval for LUMRYZ in Idiopathic Hypersomnia indication
- REVITALYZ Phase 3 trial enrollment on track, expanding potential market opportunity
- Ability to conduct new clinical trials and offer open-label extensions restored
- None.
Insights
Court victory removes legal barriers for LUMRYZ development beyond narcolepsy, enabling FDA approval pathway for Idiopathic Hypersomnia.
The Federal Circuit's decision represents a significant legal victory for Avadel, removing three critical barriers to LUMRYZ's development beyond narcolepsy. The court vacated portions of the Delaware Court's injunction that had prohibited: 1) seeking FDA approval for additional indications, 2) offering open-label extensions to trial participants, and 3) initiating new clinical trials for non-narcolepsy indications.
Most importantly, the court deemed the original restrictions "simply too speculative and tenuous," establishing a favorable legal precedent that strengthens Avadel's position against similar challenges in the future. This comprehensive reversal provides maximum flexibility for their clinical development strategy.
The ruling specifically enables advancement of LUMRYZ for Idiopathic Hypersomnia (IH) through their REVITALYZ Phase 3 trial, which remains on track to complete enrollment by end-2025. This study design as a double-blind, placebo-controlled, randomized withdrawal trial is strategically enrolling both patients switching from immediate-release oxybates and treatment-naïve participants, maximizing the potential patient population.
The ability to offer open-label extensions is particularly valuable for generating long-term safety data and maintaining patient engagement throughout the development program. This ruling effectively transforms LUMRYZ from a single-indication product to a potential platform for multiple sleep disorders.
Court ruling enhances LUMRYZ's commercial potential by enabling expansion into Idiopathic Hypersomnia and additional indications.
The Federal Circuit's favorable ruling substantially improves Avadel's strategic position by removing legal constraints on LUMRYZ's development beyond narcolepsy. With these barriers lifted, Avadel can now actively pursue approval for Idiopathic Hypersomnia and potentially other indications, significantly expanding the product's addressable market.
This legal victory directly addresses what had been a meaningful business risk constraining the company's growth narrative. The court's characterization of the original restrictions as "too speculative" suggests competitors' intellectual property claims failed to demonstrate sufficient likelihood of harm, strengthening Avadel's position against future challenges.
The ruling enables three critical business activities: 1) seeking FDA approval for new indications, 2) offering open-label extensions to trial participants, and 3) initiating new clinical trials beyond narcolepsy. This operational flexibility enhances the company's ability to execute its pipeline expansion strategy.
Management confirmation that the REVITALYZ trial remains on track for enrollment completion by end-2025 suggests these legal proceedings haven't substantially delayed development timelines. While regulatory approval still requires successful trial completion and FDA review, this legal victory removes what appears to have been a significant impediment to expanding LUMRYZ's commercial potential.
- With this ruling, Avadel can seek and be granted FDA approval for LUMRYZ in Idiopathic Hypersomnia -
- Federal Circuit decision permits new clinical trials and further development of LUMRYZ™ for the treatment of indications beyond narcolepsy -
DUBLIN, Ireland, May 06, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) has ruled in favor of Avadel, overturning important parts of the injunction imposed by the U.S. District Court for the District of Delaware (the “Delaware Court”) regarding LUMRYZ™ as a potential treatment of indications beyond narcolepsy.
The Federal Circuit vacated the portion of the injunction that prohibited Avadel from applying for FDA approval of LUMRYZ for any indication beyond narcolepsy, calling the district court’s analysis “simply too speculative and tenuous.” Additionally, the Federal Circuit lifted the portions of the Delaware Court's injunction that prohibited Avadel from offering open-label extensions to trial participants using LUMRYZ and from initiating new clinical trials or studies with LUMRYZ for potential indications beyond narcolepsy.
“We are pleased with the Federal Circuit’s decision, which paves the way for Avadel to initiate new clinical trials, offer open-label extensions in clinical trials, and ultimately seek FDA approval of LUMRYZ in IH as well as other indications,” stated Greg Divis, Chief Executive Officer of Avadel. “We remain relentlessly committed to demonstrating the clinical value of our differentiated, extended-release, once-at-bedtime medication.”
Patient enrollment in Avadel’s REVITALYZ™ trial remains on track to be completed by the end of 2025. REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and is open for participants switching from immediate-release oxybates and to those not currently taking oxybates.
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.
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.
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. |
INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients seven years and older with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
- excessive daytime sleepiness (EDS)
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.
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 litigation involving Jazz Pharmaceuticals Inc., including the potential benefits of the Federal Circuit’s ruling; the Company’s IH clinical study for LUMRYZ, including enrollment and timing related thereto; the Company’s ability to offer open-label extensions and initiate new clinical trials for LUMRYZ in indications beyond narcolepsy; and the Company’s ability to seek and obtain FDA approval for, as well as, commercially launch LUMRYZ for indications beyond narcolepsy. 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 did the Federal Circuit Court rule regarding Avadel's (AVDL) LUMRYZ?
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