NEURELIS将在美国神经病学学会年会上重点展示使用地西泮鼻喷雾剂治疗癫痫发作的分析结果-动脉网

NEURELIS WILL HIGHLIGHT ANALYSES OF SEIZURE TREATMENT WITH DIAZEPAM NASAL SPRAY AT THE AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING

CISION 等信源发布 2025-04-07 21:00

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Presentations include post hoc analyses assessing at home treatment of status epilepticus, acute seizure termination and rapid and early seizure termination, and treatment of prolonged seizures

演示内容包括事后分析，评估在家治疗癫痫持续状态、急性癫痫发作终止、快速和早期癫痫发作终止，以及长时间癫痫发作的治疗。

SAN DIEGO

圣地亚哥

，

April 7, 2025

2025年4月7日

/PRNewswire/ -- Neurelis, Inc., today announced details of three poster presentations at the American Academy of Neurology (AAN) Annual Meeting to be held

/PRNewswire/ -- Neurelis, Inc. 今天宣布了将在美国神经病学学会 (AAN) 年会上进行的三场海报展示的详细信息，该会议将于

April 5-9

4月5日至9日

in person in

亲自

San Diego

圣地亚哥

and online. The presentations include post hoc analyses of clinical data prospectively collected from studies of diazepam nasal spray as an immediate-use seizure medication for treatment of episodes of frequent seizures. Presentation topics include evaluation of early at home treatment for status epilepticus (SE), acute seizure termination and rapid and early seizure termination, and treatment of prolonged seizures..

并且在线上。这些报告包括对前瞻性收集的临床数据的事后分析，这些数据来自地西泮鼻喷雾剂作为即用型癫痫药物治疗频繁癫痫发作的研究。报告主题包括在家早期治疗癫痫持续状态（SE）、急性癫痫发作终止、快速和早期癫痫发作终止以及长时间癫痫发作的治疗评估。

'We are pleased to join the neurology community at this year's AAN Annual Meeting to discuss the latest learnings on treatments for people with epilepsy and other neurological disorders,' said

“我们很高兴在今年的美国神经病学学会年会上加入神经学界，讨论针对癫痫和其他神经系统疾病患者的最新治疗进展，”他说。

Adrian L. Rabinowicz

阿德里安·L·拉比诺维奇

, MD, Neurelis Chief Medical Officer. 'We look forward to sharing our additional analyses of data from studies of immediate-use seizure medication and joining the dialogue on clinical research that has the potential to meaningfully impact those living with the challenges of epilepsy.'

，医学博士，Neurelis首席医疗官。“我们期待分享关于即用型癫痫药物研究的更多数据分析，并参与有关临床研究的对话，这些研究有望对面临癫痫挑战的患者产生有意义的影响。”

Neurelis' Annual Meeting presentations include the following.

纽勒利斯的年度会议演示文稿包括以下内容。

Poster Session 8 –

海报会议 8 –

April 8

4月8日

，

8:00 AM-9:00 AM PT

上午8:00 - 上午9:00（太平洋时间）

：

Treatment of Status Epilepticus At and After T1 With Diazepam Nasal Spray: A Combined Cohort Analysis

使用地西泮鼻喷雾剂治疗T1及之后癫痫持续状态：联合队列分析

A post hoc analysis of pooled data from two long-term, open-label safety studies was conducted to investigate treatment of early SE episodes in patients with epilepsy aged 2-65 years. Early SE episodes were defined as seizures continuing after Time Point 1 (t1) (5 minutes for generalized seizures; 10 minutes for focal and unclassified seizures).

对两项长期、开放标签安全性研究的汇总数据进行了事后分析，以调查2至65岁癫痫患者早期SE发作的治疗情况。早期SE发作定义为在时间点1（t1）之后持续的癫痫发作（全面性发作为5分钟；局灶性和未分类发作为10分钟）。

For patients with seizure episodes reaching t1 (671 events of t1 SE in 97 patients), diazepam nasal spray provided timely control of SE episodes. Overall, safety was generally consistent with the established profile of diazepam nasal spray, and most episodes did not result in hospitalization due to serious treatment emergent adverse events (TEAEs) for SE.

对于发作次数达到t1的患者（97名患者中出现671次t1 SE事件），地西泮鼻喷雾剂能够及时控制SE发作。总体而言，其安全性与已知的地西泮鼻喷雾剂特征基本一致，且大多数发作并未因严重的治疗相关不良事件（TEAEs）导致住院。

Additionally, in a responder analysis, the majority of early SE seizures terminated prior to Time Point 2 (when neuronal injury may occur: 30 and 60 minutes for generalized and focal seizures, respectively)..

此外，在应答者分析中，大多数早期 SE 发作在时间点 2 之前终止（此时可能发生神经元损伤：全面性发作和局灶性发作分别为 30 分钟和 60 分钟）。

Poster Session 12 –

海报会议 12 –

April 9

4月9日

，

11:45 AM-12:45 PM PT

上午11点45分至下午12点45分（太平洋时间）

：

Treatment of Prolonged Seizure with Diazepam Nasal Spray: A Post Hoc Cohort Analysis

使用地西泮鼻喷雾治疗长期癫痫发作：事后队列分析

To assess effectiveness of diazepam nasal spray in treating prolonged seizures (5-15 minutes post onset) within seizure clusters (727 events), a post hoc subgroup analysis of data from the long-term safety study of diazepam nasal spray in patients aged 6-65 years was conducted. Across age, seizure type, and high treatment usage subgroups, generally similar times to seizure termination were observed.

为了评估地西泮鼻喷雾剂在治疗癫痫丛集（727次发作）中长时间发作（发作后5-15分钟）的效果，对6至65岁患者使用地西泮鼻喷雾剂的长期安全性研究数据进行了事后亚组分析。在不同年龄、发作类型和高频率治疗使用的亚组中，观察到癫痫终止的时间总体相似。

Use of second doses within 24 hours for prolonged seizures was low (9.3%) and generally consistent across subgroups, demonstrating preserved first-dose effectiveness in seizures that have become prolonged..

在长时间发作的癫痫中，24小时内使用第二剂的情况较少（9.3%），并且在各亚组中总体一致，表明在癫痫持续时间延长的情况下首剂的有效性得以保持。

Exploring Proposed Recommendations for Acute Cluster Treatment and Rapid and Early Seizure Termination Using Data from a Long-Term Safety Study of Diazepam Nasal Spray

使用来自地西泮鼻喷雾剂长期安全性研究的数据，探索急性簇集治疗和快速早期癫痫发作终止的建议推荐

Clinical data from the long-term safety study of diazepam nasal spray in patients aged 6-65 years was analyzed to determine whether it could support the recent expert consensus recommendations to terminate acute clusters and ongoing seizures that are expected to be prolonged. The effectiveness of diazepam nasal spray to prevent further seizures in a cluster was demonstrated by the low use of second doses across 24 hours.

分析了6-65岁患者使用地西泮鼻喷雾剂长期安全性研究的临床数据，以确定其是否能够支持近期专家共识建议，即终止预期会延长的急性癫痫簇和持续发作。地西泮鼻喷雾剂在24小时内通过低频率的第二剂使用，证明了其在预防癫痫簇进一步发作中的有效性。

Rapid and early seizure termination was demonstrated in a dataset of 3225 administrations. Notably, for treatment within 5 minutes of seizure onset, rapid time to seizure termination reinforced the importance of early treatment..

在3225次给药的数据集中显示了快速和早期的癫痫发作终止。值得注意的是，对于在癫痫发作开始后5分钟内进行的治疗，快速终止癫痫发作的时间强调了早期治疗的重要性。

The American Academy of Neurology and its members are focused on promoting brain health by advancing what is possible in brain disease treatment, cures, and prevention. Neurelis' work supports this mission with a dedication to improving quality of life for people with epilepsy and other neurologic disorders..

美国神经病学学会及其成员专注于通过推进脑部疾病治疗、治愈和预防的可能性来促进大脑健康。Neurelis 的工作以致力于改善癫痫和其他神经系统疾病患者的生活质量，支持了这一使命。

About Neurelis

关于Neurelis

Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older.

Neurelis, Inc. 是一家神经科学公司，专注于开发和商业化用于治疗癫痫和神经系统疾病（具有高度未满足医疗需求）的疗法。美国食品药品监督管理局 (FDA) 已批准 Neurelis 的 VALTOCO®（地西泮鼻喷雾剂）用于急性治疗间歇性、刻板型频繁癫痫发作（即癫痫丛集发作、急性重复性癫痫发作），这些发作不同于 6 岁及以上成人和儿童患者的常规癫痫模式。

VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. For more information on VALTOCO, please visit .

VALTOCO 是一种包含 INTRAVAIL® 技术的专属地西泮制剂，INTRAVAIL® 是一种经黏膜吸收增强技术，能够实现多种蛋白质、多肽和小分子药物的非侵入性递送。有关 VALTOCO 的更多信息，请访问。

www.valtoco.com

. For the latest scientific information on VALTOCO, please visit

如需了解VALTOCO的最新科学信息，请访问

http://www.neurelismedicalaffairs.com/

. Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS).

Neurelis公司还在开发NRL-1004，这是一种处于第一阶段的试验性鼻腔给药奥氮平，用于治疗与精神分裂症和双相情感障碍相关的急性躁动发作。此外，Neurelis还在开发NRL-1049（之前称为BA-1049），这是一种处于第一阶段的试验性新化学实体Rho激酶（ROCK）抑制剂，用于治疗脑海绵状血管瘤（CCMS），这是一种罕见的中枢神经系统（CNS）疾病。

For more information on Neurelis, please visit .

有关 Neurelis 的更多信息，请访问。

www.neurelis.com

。

Important Safety Information about VALTOCO:

关于VALTOCO的重要安全信息：

Indication

适应症

VALTOCO

瓦尔托科

(diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.

（地西泮鼻喷雾剂）适用于6岁及以上癫痫患者间歇性、刻板型频繁发作活动（即，癫痫簇集、急性重复性癫痫发作）的急性治疗，这些发作与患者的常规癫痫模式不同。

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

警告：与阿片类药物同时使用的风险；滥用、误用和成瘾；以及依赖性和戒断反应

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation..

同时使用苯二氮卓类药物和阿片类药物可能导致深度镇静、呼吸抑制、昏迷甚至死亡。仅在其他治疗方案不足的情况下，才考虑同时开具这些药物。应将剂量和疗程限制在最低必要范围内。监测患者是否出现呼吸抑制和镇静的体征和症状。

The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.

使用包括VALTOCO在内的苯二氮卓类药物，会使使用者面临滥用、误用和成瘾的风险，这可能导致过量服用或死亡。苯二氮卓类药物的滥用和误用通常涉及同时使用其他药物、酒精和/或非法物质，这与严重不良后果的发生频率增加相关。

Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction..

在开VALTOCO处方之前及整个治疗过程中，评估每位患者滥用、误用和成瘾的风险。

The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening.

苯二氮卓类药物的持续使用可能导致临床上显著的身体依赖。依赖和戒断的风险随着治疗时间的延长和每日剂量的增加而增加。虽然VALTOCO仅适用于间歇性使用，但如果使用频率超过推荐值，突然停用或迅速减少VALTOCO剂量可能引发急性戒断反应，这可能是危及生命的。

For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO..

对于使用VALTOCO频率高于推荐的患者，为降低戒断反应的风险，应逐步减量以停止使用VALTOCO。

Contraindications:

禁忌症：

VALTOCO is contraindicated in patients with:

VALTOCO禁用于以下患者：

Hypersensitivity to diazepam

对地西泮过敏

Acute narrow-angle glaucoma

急性闭角型青光眼

Central Nervous System (CNS) Depression

中枢神经系统（CNS）抑制

Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits..

苯二氮卓类药物，包括VALTOCO，可能会导致中枢神经系统抑制。在药物作用（如嗜睡）消退之前，且在患者身体状况允许的情况下，应提醒患者避免从事需要精神警觉的危险活动，例如操作机器、驾驶机动车或骑自行车。

The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner.

必须考虑 VALTOCO 与酒精或其他中枢神经系统抑制剂合用时产生协同中枢神经系统抑制作用的可能性，并向患者和/或护理人员作出适当建议。

Suicidal Behavior and Ideation

自杀行为和意念

Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.

抗癫痫药物（AEDs），包括VALTOCO，会增加自杀意念和行为的风险。任何接受AED治疗的患者都应监测是否出现或加重抑郁、自杀念头或行为，以及情绪或行为的异常变化。

Glaucoma

青光眼

Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

苯二氮卓类药物，包括VALTOCO，会增加青光眼患者的眼内压。仅当开角型青光眼患者正在接受适当治疗时，才可以使用VALTOCO。VALTOCO禁用于窄角型青光眼患者。

Neonatal Sedation and Withdrawal Syndrome

新生儿镇静和戒断综合征

Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly..

在妊娠晚期使用VALTOCO可导致新生儿出现镇静（呼吸抑制、嗜睡、肌张力低下）和/或戒断症状（反射亢进、易激惹、不安、震颤、无法安慰的哭泣和喂养困难）。监测在妊娠期或分娩期间暴露于VALTOCO的新生儿是否有镇静迹象，并监测在妊娠期暴露于VALTOCO的新生儿是否有戒断症状；相应地管理这些新生儿。

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

苯甲醇防腐剂可能导致婴儿严重不良反应的风险

VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including 'gasping syndrome,' can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The 'gasping syndrome' is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

VALTOCO未被批准用于新生儿或婴儿。使用含苯甲醇的药物（包括VALTOCO）治疗新生儿和低出生体重婴儿时，可能会发生严重甚至致命的不良反应，包括“喘息综合征”。“喘息综合征”的特征是中枢神经系统抑制、代谢性酸中毒和喘息样呼吸。

The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known..

未确定可能发生严重不良反应的苯甲醇最低量。

Adverse Reactions

不良反应

The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.

最常见的不良反应（至少4%）为嗜睡、头痛和鼻部不适。

Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.

地西泮（VALTOCO的活性成分）是第四类管制物质。

To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (

要报告可疑的不良反应，请联系 Neurelis, Inc.，电话：1-866-696-3873 或 FDA，电话：1-800-FDA-1088 (

www.fda.gov/medwatch