Avadel Pharmaceuticals Announces Favorable Ruling in Administrative Procedure Act Litigation
Avadel Pharmaceuticals Announces Favorable Ruling in Administrative Procedure Act Litigation
DUBLIN, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that yesterday, the U.S. District Court for the District of Columbia ("Court") ruled in favor of the Food and Drug Administration ("FDA") in a suit brought by Jazz Pharmaceuticals Inc. ("Jazz") under the Administrative Procedure Act regarding the FDA's approval of LUMRYZTM, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy. With this ruling, the approval of LUMRYZ is upheld based on the FDA's determination that LUMRYZ is clinically superior to Jazz's twice-nightly oxybate products.
DUBLIN，2024年10月31日，GLOBE NEWSWIRE報道 -- Avadel Pharmaceuticals plc（納斯達克：AVDL），一家專注於轉化藥物以改變生活的生物製藥公司，宣佈昨天，美國哥倫比亞特區地方法院（"法院"）裁定支持食品藥品監督管理局（"FDA"）的決定。在由Jazz製藥公司（"爵士"）根據管理規程法提起的訴訟中，該訴訟是關於FDA對LUMRYZTm的批准，這是首個也是唯一一個用於治療成年人因納爾透症所致的貓癱或白天過度嗜睡的一次夜間治療的氧酸鹽產品。通過這一裁決，基於FDA的判斷LUMRYZ在臨床上優於Jazz的兩次夜間氧酸鹽產品，LUMRYZ的批准維持不變。
Following the FDA's final approval and grant of Orphan Drug Exclusivity ("ODE") to LUMRYZ in May 2023, Jazz filed a complaint against the FDA claiming that LUMRYZ's approval was not in alignment with the Orphan Drug Act. Avadel CNS Pharmaceuticals, LLC ("Avadel CNS") intervened to defend the FDA's actions and successfully argued to uphold approval of LUMRYZ.
在FDA最終批准並授予LUMRYZ孤兒藥專屬權（"ODE"）後，Jazz於2023年5月對FDA提出了投訴，聲稱LUMRYZ的批准不符合孤兒藥法案。Avadel CNS製藥有限責任公司（"Avadel CNS"）介入爲辯護FDA的行爲，併成功辯稱支持LUMRYZ的批准。
"We are pleased with the Court's ruling in favor of the FDA's clinical superiority determination for LUMRYZ in conjunction with final approval for use in adults with narcolepsy. With the Court's decision, LUMRYZ will continue to be available to the narcolepsy community and retain its Orphan Drug Exclusivity," said Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals. "Yesterday's ruling further solidifies LUMRYZ's unique once-at-bedtime dosing schedule as a major contribution to patient care and enables us to continue executing on our commercial launch and expanding LUMRYZ's reach within the narcolepsy community."
"我們對法院支持FDA對LUMRYZ的臨床優越性判斷以及最終批准在成年人中使用的決定表示滿意。在法院的決定下，LUMRYZ將繼續供應給納爾透症社區，並保持其孤兒藥專屬性，"Avadel Pharmaceuticals首席執行官Greg Divis表示"昨天的裁決進一步鞏固LUMRYZ獨特的一次夜間服藥計劃，這對患者的護理是一個重要貢獻，並使我們能夠繼續執行我們的商業推出計劃，擴大LUMRYZ在納爾透症社區內的影響。"
About LUMRYZ (sodium oxybate) for extended-release oral suspension
關於LUMRYZ（醇氧酸鈉）的緩釋口服混懸液
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.
LUMRYZ是一種經FDA於2023年5月1日批准的緩釋醇氧酸鈉藥物，是首個也是唯一一個用於治療納爾透症成年人貓癱或白天過度嗜睡（EDS）的一次夜間治療。2024年10月16日，LUMRYZ還被批准作爲一種一次夜間治療，用於年齡超過7歲的納爾透症兒童患者的貓癱或EDS。
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.
LUMRYZ的FDA批准得到了來自RESt-ON研究的支持，該研究是一項隨機、雙盲、安慰劑對照的關鍵三期試驗，針對成年人患有睡病症。與安慰劑相比，LUMRYZ在三個主要終點指標上表現出統計學上顯著和臨床意義重大的改善：過度白天嗜睡（MWT）、臨床醫師對患者功能的整體評估（CGI-I）以及猝倒發作。
With its original approval in May 2023, the FDA granted 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy 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. Similarly, with its pediatric approval in October of 2024, the FDA granted another 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in patients 7 years and older with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found there that LUMRYZ's dosing makes a major contribution to patient care by providing an opportunity to minimize sleep fragmentation and disruption of sleep architecture in a way that is not possible for a patient on a twice-nightly dosing regimen of oxybate.
LUMRYZ最初於2023年5月獲得批准，在針對睡病患者中治療猝倒或白天過度嗜睡（EDS）方面，FDA授予LUMRYZ 7年孤兒藥獨家權。這是因爲LUMRYZ相對於目前可用的氧丁酸鹽治療具有臨床上的優勢。尤其是，FDA發現LUMRYZ通過提供每晚一次的服藥方案，避免了爲了服用第二劑藥而在夜間醒來，對患者護理做出了重大貢獻。同樣，在2024年10月獲得兒童批准後，FDA再次授予LUMRYZ治療年齡在7歲及以上患有睡病的患者猝倒或EDS 7年孤兒藥獨家權。FDA發現，LUMRYZ的服藥方式對患者護理有重大貢獻，因爲它提供了減少睡眠碎片化和破壞的機會，這是目前採用氧丁酸鹽的一天兩次服藥方案無法實現的。
About Avadel Pharmaceuticals plc
關於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 excessive daytime sleepiness (EDS) in patients 7 years and older with narcolepsy. For more information, please visit .
avadel pharmaceuticals plc（納斯達克：AVDL）是一家專注於改變藥物以改變生活的生物製藥公司。我們的方法包括應用創新解決方案開發藥物，解決患者在當前治療選擇中面臨的挑戰。Avadel的商業產品LUMRYZ已獲得美國食品藥品監督管理局（FDA）批准，作爲首個且唯一一種每晚一次服用的氧丁酸鹽，用於治療年齡在7歲及以上患有睡病的患者的猝倒或白天過度嗜睡（EDS）。欲了解更多信息，請訪問。
IMPORTANT SAFETY INFORMATION
重要安全信息
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. |
警告：與其他中樞神經系統（CNS）抑制劑一起使用LUMRYZ（奧斯卡酸鈉），例如用於使您入睡的藥物，包括阿片類鎮痛藥，苯二氮䓬類藥物，安眠抗抑鬱藥，抗精神病藥，安眠抗癲癇藥，全身麻醉藥，肌肉鬆弛藥，酒精或街頭藥物，可能會導致嚴重的醫療問題，包括呼吸困難（呼吸抑制），低血壓（低血壓），警覺度改變（嗜睡），昏厥（暈厥）和死亡。 |
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:
適應症
用於7歲及以上患有睡病的患者的延釋口服懸浮液LUMRYZ（奧斯卡酸鈉）是一種處方藥，用於治療以下症狀：
sudden onset of weak or paralyzed muscles (cataplexy)
excessive daytime sleepiness (EDS)
肌肉突然無力或癱瘓（癲癇發作）
白天過度嗜睡（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.
如果您或您的孩子服用其他安眠藥或鎮定劑（會導致嗜睡的藥物），喝酒或患有稱爲琥珀酸半乙醛脫氫酶缺乏症的罕見問題，請勿服用LUMRYZ。
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.
將LUMRYZ放在安全的地方以防止濫用和誤用。出售或轉讓LUMRYZ可能會傷害他人，並且違反法律。告訴您的醫生，如果您或您的孩子曾經濫用或依賴酒精、處方藥物或街頭藥物。
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.
服用LUMRYZ的人不應進行任何要求他們完全清醒或危險的活動，包括駕駛汽車、使用重型機械或駕駛飛機，以及服用LUMRYZ後至少六（6）小時內不應進行這些活動。在了解LUMRYZ對您產生影響之前，不應進行這些活動。
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.
迅速入睡，包括站立或從牀上起牀時入睡，可能導致摔倒並受傷，導致一些人需要入院治療。
LUMRYZ can cause serious side effects, including the following:
LUMRYZ 可能會引起嚴重的副作用，包括以下內容：
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.
呼吸問題，包括呼吸變慢、呼吸困難和/或睡眠時呼吸暫停（例如，睡眠呼吸暫停）。已經有呼吸或肺部問題的人在服用LUMRYZ時出現呼吸問題的可能性更高。
心理健康問題，包括混亂、看到或聽到並不存在的事物（幻覺）、不尋常或令人不安的思維（異常思維）、感到焦慮或心煩、抑鬱、自殺念頭或試圖自殺、疲勞加重、罪惡或無價值感、注意力困難。告訴醫生，如果您或您的孩子有抑鬱症狀，或曾經嘗試傷害自己。如果您或您的孩子出現心理健康問題症狀或體重或食慾變化，請立即撥打醫生電話。
夢遊。夢遊可能會導致受傷。如果您或您的孩子開始夢遊，請立即致電醫生。
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.
如果您或您的孩子正在進行限鹽飲食，或有高血壓、心力衰竭或腎臟問題，請告訴醫生。LUMRYZ含有大量鈉（鹽），可能不適合您。
LUMRYZ在成人中最常見的副作用包括噁心、頭暈、遺尿、頭痛和嘔吐。當您服用更高劑量的LUMRYZ時，您可能會出現副作用。兒童中最常見的副作用包括噁心、遺尿、嘔吐、頭痛、體重減輕、食慾減退、頭暈和夢遊。如果不按照指示服用，LUMRYZ可能導致對藥物的依賴和渴望。這些並非所有可能的LUMRYZ副作用。
For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
如需更多信息，請諮詢您的醫生或藥劑師。致電醫生諮詢有關副作用的醫療建議。
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.
鼓勵您向FDA報告處方藥的負面副作用。請訪問 或撥打 1-800-FDA-1088。
Please see full Prescribing Information, including BOXED Warning.
請參閱完整的處方說明，包括 WARNING.
譯文內容由第三人軟體翻譯。
