OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo.

OnabotulinumtoxinA（BOTOX®）在二期试验中达到了主要终点，与安慰剂相比，在修订后的震颤残疾量表（TREDS-R）总单侧评分中显示出从基线开始统计学显著改善。

1

1

The trial also met all six secondary endpoints.

该试验还达到了所有六个次要终点。

2

2

Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.

安全性分析的结果通常与onabotulinumtoxinA的既定安全性特征一致。

1

1

NORTH CHICAGO, Ill.

伊利诺伊州北芝加哥市

,

，

Oct. 6, 2025

2025年10月6日

/

/

PRNewswire

美通社

/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared to placebo for the treatment of upper limb essential tremor.

/ -- 艾伯维（AbbVie，纽约证券交易所代码：ABBV）今天宣布了2期ELATE试验的积极顶线结果，该试验评估了onabotulinumtoxinA（BOTOX®）与安慰剂相比在治疗上肢原发性震颤方面的安全性和有效性。

The study met its primary endpoint, demonstrating statistically significant improvements in the Tremor Disability Scale-Revised (TREDS-R) of onabotulinumtoxinA compared to placebo at week 18. Specifically, the onabotulinumtoxinA group showed a greater reduction in TREDS-R total unilateral score compared to placebo, with scores of -2.61 versus -1.61, (p=0.029)..

该研究达到了其主要终点，证明在第18周时，与安慰剂相比，ona肉毒杆菌毒素A在修订版震颤残疾量表（TREDS-R）上显示出统计学显著改善。具体而言，ona肉毒杆菌毒素A组的TREDS-R单侧总分下降幅度大于安慰剂组，得分分别为-2.61和-1.61（p=0.029）。

1

1

The study also met all six secondary endpoints.

该研究还达到了所有六个次要终点。

2

2

'Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments,' said

“特发性震颤是一种进展性的神经系统疾病，影响着全世界数百万人，目前的治疗方法往往效果不佳，”

Daniel Mikol

丹尼尔·米科勒

, M.D., Ph.D., vice president, neuroscience development, AbbVie. 'No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate further proof of mechanism for a neurotoxin as a potential treatment option to help patients and healthcare providers manage this challenging condition.'.

医学博士、哲学博士、艾伯维神经科学开发副总裁表示：“美国超过30年没有批准针对特发性震颤的新药治疗。这些结果代表了重大的进展，并进一步证明了神经毒素作为一种潜在治疗选择的作用机制，有助于患者和医疗保健提供者管理这一具有挑战性的疾病。”

Safety results were generally consistent with the well-established safety profile of onabotulinumtoxinA. Muscular weakness was the most common adverse event, with reported rates of 24.5% in the onabotulinumtoxinA group versus 2.3% in the placebo group. Instances were localized and transient and most were classified as mild or moderate in nature..

安全性结果通常与onabotulinumtoxinA已确立的安全性特征一致。肌肉无力是最常见的不良事件，在onabotulinumtoxinA组中的报告率为24.5%，而安慰剂组为2.3%。这些事件是局部的和短暂的，大多数被归类为轻度或中度。

1

1

Results from the study will be presented at the International Congress of Parkinson's Disease and Movement Disorders® on

研究结果将在国际帕金森病和运动障碍大会®上公布。

October 8, 2025

2025年10月8日

.

。

The use of BOTOX® for essential tremor is not approved by the U.S. Food and Drug Administration (FDA) or any other global regulatory authority and its safety and efficacy have not been evaluated by regulatory authorities.

BOTOX® 用于治疗原发性震颤尚未获得美国食品药品监督管理局 (FDA) 或任何其他全球监管机构的批准，其安全性和有效性也未经过监管机构的评估。

About the ELATE Study

关于ELATE研究

The ELATE trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of upper limb essential tremor in adults. The primary efficacy measure was the change in the Tremor Disability Scale-Revised (TREDS-R) total score across seven unilateral items from baseline across weeks 15, 18 and 21.

ELATE 试验是一项二期多中心、随机、双盲、安慰剂对照、平行组研究，旨在评估 onabotulinumtoxinA 治疗成人上肢原发性震颤的安全性和有效性。主要疗效指标是第 15、18 和 21 周时 Tremor Disability Scale-Revised（TREDS-R）在七个单侧项目上的总分较基线的变化。

Secondary outcome measures included activity of daily living assessment, various tremor assessment scales and global impression of severity scores..

次要结局指标包括日常生活活动能力评估、各种震颤评估量表和严重程度总体印象评分。

More information on the ELATE trial can be found on

有关ELATE试验的更多信息，请访问

www.clinicaltrials.gov

www.clinicaltrials.gov

.

。

About Essential Tremor

关于原发性震颤

Essential tremor is the most common movement disorder, impacting approximately 25–60 million individuals worldwide.

特发性震颤是最常见的运动障碍，影响全世界约 2.5 至 6 千万人。

3

3

This condition complicates physical activities due to uncontrollable and involuntary action tremors and furthermore often results in depression, anxiety and social embarrassment, thereby affecting overall quality of life.

这种状况由于无法控制和不自主的动作震颤而使身体活动变得复杂，并且常常导致抑郁、焦虑和社交尴尬，从而影响整体生活质量。

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4

Current treatment options are limited in both efficacy and tolerability often leaving patients with few viable options.

目前的治疗选择在有效性和耐受性方面都有限，常常使患者几乎没有可行的选择。

About BOTOX

关于BOTOX

®

®

(onabotulinumtoxinA)

（onabotulinumtoxinA）

BOTOX

保妥适

®

®

was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX

1989年首次获得FDA批准，用于治疗两种罕见的眼肌疾病——成人睑痉挛和斜视。如今，BOTOX

®

®

is FDA-approved for multiple therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to detrusor overactivity associated with a neurologic condition in adults and in pediatric patients five years of age and older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis).

获得FDA批准用于多种治疗适应症，包括慢性偏头痛、膀胱过度活动症、因成人和五岁及以上儿童神经系统疾病相关的逼尿肌过度活动导致的尿失禁、颈肌张力障碍、成人和儿童痉挛状态，以及严重的腋下多汗症（腋窝多汗症）。

BOTOX® is not FDA-approved for essential tremor..

BOTOX® 未获 FDA 批准用于治疗特发性震颤。

BOTOX

肉毒杆菌素

®

®

(onabotulinumtoxinA) Important Information

（onabotulinumtoxinA）重要信息

U.S. Indications

美国适应症

BOTOX

保妥适

®

®

(onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used:

（ona肉毒杆菌毒素A）是一种处方药，注射到肌肉中并用于：

To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.

用于治疗膀胱过度活动症症状，如成人18岁及以上出现的强烈排尿需求伴随漏尿或尿失禁（急迫性尿失禁）、立即排尿的强烈需求（紧迫感）以及频繁排尿（频尿），当另一种药物（抗胆碱能药物）效果不佳或无法服用时使用。

To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken

用于治疗因神经疾病导致膀胱过度活动症的18岁及以上成人尿液泄漏（尿失禁），当另一种药物（抗胆碱能药物）效果不佳或无法服用时。

To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken

用于治疗因神经系统疾病引起的膀胱过度活动症，适用于5岁及以上儿童，当其他类型的药物（抗胆碱能药物）效果不佳或无法服用时。

To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older

预防每月有15天或更多头痛、且每天持续4小时或以上的成人慢性偏头痛（适用于18岁及以上人群）。

To treat increased muscle stiffness in people 2 years of age and older with spasticity

用于治疗2岁及以上痉挛性肌肉僵硬患者增加的肌肉僵硬。

To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older

用于治疗16岁及以上人群因颈椎肌张力障碍（CD）而出现的头部姿势异常和颈部疼痛问题。

To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older

用于治疗12岁及以上人群的某些类型的眼肌问题（斜视）或眼睑异常痉挛（睑痉挛）。

BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

BOTOX 也可注射到皮肤中，用于治疗严重腋下出汗（严重的原发性腋窝多汗症）的症状，当用于皮肤（局部）的药物在 18 岁及以上的人群中效果不佳时。

It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

目前尚不清楚BOTOX对于每月有14天或更少头痛天数的偏头痛患者（偶发性偏头痛）预防头痛是否安全有效。

BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

保妥适尚未被证明可以帮助人们用上肢执行特定任务或增加因僵硬肌肉而永久固定位置的关节的活动性。

It is not known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits.

除腋窝外，BOTOX 对其他部位严重出汗的安全性和有效性尚不清楚。

U.S. IMPORTANT SAFETY INFORMATION

美国重要安全信息

BOTOX may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX:

BOTOX可能会引起严重的、可能危及生命的副作用。如果在注射BOTOX后（数小时至数周内）出现以下任何问题，请立即就医：

Problems swallowing, speaking, or breathing,

吞咽、说话或呼吸困难，

due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.

由于相关肌肉的弱化，可能会非常严重并导致生命危险。如果在注射前就存在这些问题，那么风险最高。吞咽困难可能会持续数月。

Spread of toxin effects.

毒素效应的传播。

The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness; double vision; blurred vision; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing..

肉毒杆菌毒素的作用可能会影响到远离注射部位的区域，并引起严重的症状，包括体力下降和全身肌肉无力；复视；视力模糊；眼睑下垂；声音嘶哑或改变或失声；说话不清；膀胱失控；呼吸困难；以及吞咽困难。

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.

当按照推荐剂量使用BOTOX治疗慢性偏头痛、严重腋下出汗、眼睑痉挛或斜视时，尚未有确认的严重毒素效应扩散到注射部位以外的案例。

BOTOX may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX.

在注射BOTOX后的数小时至数周内，BOTOX可能导致体力丧失或全身肌肉无力、视力问题或头晕。

If this happens, do not drive a car, operate machinery, or do other dangerous activities.

如果发生这种情况，请勿驾驶汽车、操作机器或进行其他危险活动。

Do not receive BOTOX if you

如果你有以下情况，请勿接受BOTOX：

are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc

对BOTOX中的任何成分过敏（见药品指南中的成分）；对其他肉毒杆菌毒素产品如Myobloc有过敏反应

®

®

(rimabotulinumtoxinB), Dysport

（里马肉毒杆菌毒素B），Dysport

®

®

(abobotulinumtoxinA), Xeomin

(abobotulinumtoxinA)，Xeomin

®

®

(incobotulinumtoxinA), Jeuveau

（英科波特利那毒素A），Jeuveau

®

®

(prabotulinumtoxinA-xvfs), Daxxify

(prabotulinumtoxinA-xvfs)，Daxxify

®

®

(daxibotulinumtoxinA-lanm), or Letybo

（大西博特ulinumtoxinA-lanm），或Letybo

®

®

(letibotulinumtoxinA-wlbg) (this may not be a complete list of all botulinum toxin products); have a skin infection at the planned injection site.

（letibotulinumtoxinA-wlbg）（这可能不是所有肉毒杆菌毒素产品的完整列表）；在计划注射部位有皮肤感染。

Do not receive BOTOX for the treatment of urinary incontinence if you

如果您有以下情况，请勿接受BOTOX治疗尿失禁

have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate catheterization posttreatment, if required, should be considered for treatment..

患有尿路感染（UTI）或无法自行排空膀胱且未常规导尿的患者。由于存在尿潴留（难以完全排空膀胱）的风险，只有愿意并且能够在治疗后必要时进行导尿的患者才应被视为适合接受治疗。

Patients treated for overactive bladder:

接受膀胱过度活动症治疗的患者：

In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2).

在临床试验中，552 名接受 BOTOX 治疗的患者中有 36 名因尿潴留需要自我导尿，而 542 名接受安慰剂治疗的患者中有 2 名需要自我导尿。接受 100 单位 BOTOX 治疗的患者（n = 36）导尿的中位持续时间为 63 天（最短 1 天，最长 214 天），而接受安慰剂治疗的患者（n = 2）导尿的中位持续时间为 11 天（最短 3 天，最长 18 天）。

Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics..

接受BOTOX治疗的糖尿病患者比非糖尿病患者更容易出现尿潴留。

Adult patients treated for overactive bladder due to a neurologic disease:

因神经系统疾病导致膀胱过度活动症而接受治疗的成年患者：

In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7)..

在临床试验中，30.6%（33/108）的成年患者在注射BOTOX 200单位之前未使用清洁间歇导尿（CIC），但治疗后因尿潴留需要导尿，而接受安慰剂治疗的患者中这一比例为6.7%（7/104）。这些接受BOTOX 200单位治疗的患者（n = 33）导尿的中位持续时间为289天（最短1天，最长530天），而接受安慰剂治疗的患者（n = 7）的中位持续时间为358天（最短2天，最长379天）。

Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection than those with spinal cord injury.

在基线时未使用清洁间歇导尿（CIC）的成年患者中，多发性硬化症患者比脊髓损伤患者更可能在注射后需要使用CIC。

The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product.

BOTOX的剂量与另一种肉毒杆菌毒素产品不同，也不可比较。

Serious and/or immediate allergic reactions have been reported

已报告严重和/或立即的过敏反应

,

，

including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued.

包括瘙痒；皮疹；红色、发痒的荨麻疹；喘息；哮喘症状；头晕；或感到昏厥。如果出现症状，请立即就医；应停止继续注射BOTOX。

Tell your doctor about all your muscle or nerve conditions

告诉你的医生你所有的肌肉或神经状况。

,

，

such as ALS or

例如ALS或

Lou Gehrig's

卢·格里克病

disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing from typical doses of BOTOX.

疾病、重症肌无力或Lambert-Eaton综合征，因使用常规剂量的BOTOX可能会增加严重副作用的风险，包括吞咽困难和呼吸困难。

Tell your doctor if you have any breathing-related problems.

如果您有任何呼吸相关的问题，请告诉您的医生。

Your doctor may monitor you for breathing problems during treatment with BOTOX for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX.

在使用BOTOX治疗痉挛或与神经系统疾病相关的逼尿肌过度活动时，您的医生可能会监测您的呼吸问题。对于肺功能减退的患者，接受BOTOX治疗后出现肺病的风险会增加。

Cornea problems have been reported.

已报告有角膜问题。

Cornea (surface of the eye) problems have been reported in some people receiving BOTOX for their blepharospasm, especially in people with certain nerve disorders. BOTOX may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX.

一些接受保妥适治疗眼睑痉挛的患者报告出现了角膜（眼睛表面）问题，尤其是在某些神经疾病患者中。保妥适可能会导致眼睑眨眼次数减少，从而使眼睛表面比平常更多地暴露在空气中。如果在接受保妥适治疗期间遇到任何眼部问题，请告知您的医生。

Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch..

您的医生可能会使用滴眼液、药膏、隐形眼镜或眼罩来治疗您的眼睛。

Bleeding behind the eye has been reported.

眼后出血已被报道。

Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX.

据报道，一些因斜视而接受BOTOX治疗的人出现了眼球后出血的情况。如果在使用BOTOX期间出现任何新的视力问题，请告知您的医生。

Bronchitis and upper respiratory tract infections (common colds) have been reported.

已报告出现支气管炎和上呼吸道感染（普通感冒）。

Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more frequently.

接受BOTOX治疗上肢痉挛的成人中，支气管炎的报告频率更高。既往有呼吸相关问题的痉挛成年患者中，上呼吸道感染的报告频率也更高。在使用BOTOX治疗上肢痉挛的儿科患者中，上呼吸道感染的报告频率同样更高。

In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo..

在使用BOTOX治疗下肢痉挛的儿科患者中，上呼吸道感染的发生频率并未比安慰剂组更高。

A

A

u

你

t

t

onomic dysreflexia in patients treated for overactive bladder due to a neurologic disease.

由于神经系统疾病导致膀胱过度活动症治疗的患者出现onomic失调。

Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively)..

与膀胱内注射BOTOX相关的自主神经功能障碍可能发生在因神经性疾病导致逼尿肌过度活动而接受治疗的患者中，可能需要及时的医疗干预。在临床试验中，使用200单位BOTOX治疗的成年患者中自主神经功能障碍的发生率高于安慰剂组（分别为1.5%和0.4%）。

Tell your doctor about all your medical conditions, including if you

告诉您的医生您的所有医疗状况，包括如果您

have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX passes into breast milk)..

有或曾经有出血问题；计划进行手术；面部曾接受过手术；有额肌无力、抬眉困难、眼睑下垂及其他任何异常的面部变化；有尿路感染症状并正因尿失禁接受治疗（尿路感染症状可能包括排尿时疼痛或灼烧感、尿频或发烧）；存在自行排空膀胱困难并正因尿失禁接受治疗；怀孕或计划怀孕（尚不清楚BOTOX是否会对胎儿造成伤害）；正在哺乳或计划哺乳（尚不清楚BOTOX是否会进入母乳）。

Tell your doctor about all the medicines you take,

告诉您的医生您所服用的所有药物，

including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain other medicines may cause serious side effects.

包括处方药和非处方药、维生素以及草本补充剂。将BOTOX与其他某些药物一起使用可能会导致严重的副作用。

Do not start any new medicines until you have told your doctor that you have received BOTOX in the past.

在您告知医生您过去曾接受过BOTOX治疗之前，请勿开始使用任何新药。

Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc

告诉你的医生你过去4个月内是否使用过其他肉毒杆菌毒素产品；是否接受过如Myobloc等肉毒杆菌毒素注射。

®

®

, Dysport

，Dysport（ Dysport是一种药物品牌，通常用于治疗肌肉痉挛和皱纹等）

®

®

, Xeomin

，Xeomin

®

®

, Jeuveau

，Jeuveau

®

®

, Daxxify

，Daxxify

®

®

, or Letybo

，或者Letybo

®

®

in the past (this may not be a complete list of all botulinum toxin products; tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners..

在过去（这可能不是所有肉毒杆菌毒素产品的完整列表；请准确告知医生你使用了哪种产品）；最近是否接受过抗生素注射；是否服用肌肉松弛剂；是否服用过敏药或感冒药；是否服用安眠药；是否服用类似阿司匹林的产品或血液稀释剂。

Other side effects of BOTOX include

BOTOX的其他副作用包括

dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include UTI and painful urination.

口干；注射部位不适或疼痛；疲倦；头痛；颈痛；视力问题，如复视、视力模糊、视力下降、眼睑下垂、眼睑肿胀和眼睛干涩；眉毛下垂；上呼吸道感染。在治疗尿失禁的成人中，其他副作用包括尿路感染和排尿疼痛。

In children being treated for urinary incontinence, other side effects include UTI; bacteria, white blood cells, and blood in the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder on your own after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again..

在治疗尿失禁的儿童中，其他副作用包括尿路感染；尿液中的细菌、白细胞和血液。在治疗尿失禁的患者中，另一副作用包括无法自行排空膀胱。如果您在接受BOTOX治疗后难以完全自行排空膀胱，您可能需要使用一次性自用导尿管，每天几次，直到您的膀胱能够再次自行排空为止。

For more information, refer to the Medication Guide or talk with your doctor.

有关更多信息，请参阅药品指南或与您的医生交谈。

You are encouraged to report negative side effects of prescription drugs to the FDA.

我们鼓励您向FDA报告处方药的不良副作用。

Visit

访问

www.fda.gov/medwatch

www.fda.gov/medwatch

or call 1-800-FDA-1088.

或拨打1-800-FDA-1088。

If you are having difficulty paying for your medicine, AbbVie may be able to help.

如果您在支付药品费用方面遇到困难，AbbVie 可能能够提供帮助。

Visit AbbVie.com/PatientAccessSupport to learn more.

访问AbbVie.com/PatientAccessSupport了解更多信息。

Please see BOTOX

请参见BOTOX

®

®

full

满的

Product Information

产品信息

, including Boxed Warning and

，包括加框警告和

Medication Guide

药品指南

.

。

Globally, prescribing information varies; refer to the individual country product label for complete information.

全球范围内，处方信息各不相同；欲获取完整信息，请参阅各个国家的产品标签。

About AbbVie

关于艾伯维

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.

艾伯维的使命是发现并提供创新的药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们力求在包括免疫学、肿瘤学、神经科学和眼科在内的几个关键治疗领域对人们的生活产生显著影响，并通过我们的艾尔建美学产品和服务组合产生积极影响。

For more information about AbbVie, please visit us at .

欲了解有关艾伯维的更多信息，请访问我们的网站。

www.abbvie.com

www.abbvie.com

. Follow @abbvie on

关注 @abbvie

LinkedIn,

LinkedIn，

Facebook

Facebook

,

，

Instagram

Instagram

,

，

X (formerly Twitter)

X（前称Twitter）

and

和

YouTube

YouTube

.

。

Forward-Looking Statements

前瞻性声明

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements.

本新闻稿中的某些声明，或者可能被视为，1995年《私人证券诉讼改革法案》意义上的前瞻性声明。“相信”、“预期”、“预见”、“规划”等词语及类似表达和未来或条件动词的使用，通常用于识别前瞻性声明。

AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations.

艾伯维提醒，这些前瞻性陈述受到可能导致实际结果与前瞻性陈述中明示或暗示的结果存在重大差异的风险和不确定性的影响。这些风险和不确定性包括但不限于知识产权方面的挑战、来自其他产品的竞争、研发过程中固有的困难、不利的诉讼或政府行为、适用于我们行业的法律法规的变化、全球宏观经济因素的影响（如经济衰退或不确定性）、国际冲突、贸易争端和关税，以及与全球业务运营相关的其他不确定性和风险。

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information.

有关可能影响AbbVie运营的经济、竞争、政府、技术及其他因素的更多信息，请参见AbbVie于2024年提交给证券交易委员会的10-K表格年度报告中的第1A项“风险因素”，并以其10-Q表格季度报告及AbbVie随后向证券交易委员会提交的更新、补充或取代该信息的其他文件为准。

AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law..

AbbVie 不承担任何义务，并明确拒绝因后续事件或发展而公开发布对前瞻性声明的修订，除非法律要求。

AbbVie Media:

艾伯维媒体：

Liz Tang, Ph.D.

唐丽兹，博士

liz.tang@abbvie.com

liz.tang@abbvie.com

Investors:

投资者：

Liz Shea

莉兹·谢伊

liz.shea@abbvie.com

liz.shea@abbvie.com

References:

参考文献：

Patel A., Patterson K., Khosla D., et al. Results From the ELATE Trial: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of OnabotulinumtoxinA for the Treatment of Upper Limb Essential Tremor. Presented at: International Congress of Parkinson's Disease and Movement Disorders (MDS); .

帕特尔 A.， 帕特森 K.， 科斯拉 D.， 等。 ELATE 试验结果：一项关于使用肉毒杆菌毒素A治疗上肢原发性震颤的 2 期多中心、随机、双盲、安慰剂对照研究。 在国际帕金森病与运动障碍大会 (MDS) 上发表；。

October 5, 2025

2025年10月5日

;

；

Honolulu, HI

檀香山，夏威夷州

(Late-Breaking Abstract).

（最新发表的摘要）。

AbbVie. Data on file ABVRRTI81777.

艾伯维。文件数据 ABVRRTI81777。

Song P., Zhang Y., Zha M., et al. The global prevalence of essential tremor, with emphasis on age and sex: A meta-analysis. J Glob Health. 2021; 11:04028, 202.

宋鹏、张勇、查敏等。全球原发性震颤的患病率，重点关注年龄和性别：一项荟萃分析。《全球健康杂志》。2021年；11:04028，202页。

Crawford P., Zimmerman EE., Am Fam Physician. 2018;97(3):180–186; 2.

克劳福德 P., 齐默尔曼 EE., 《美国家庭医生》。2018;97(3):180–186; 2.

SOURCE AbbVie

来源：艾伯维（AbbVie）