2018年7月5日，美国食品和药物管理局（FDA）已批准神经毒素产品Xeomin（incobotulinumtoxinA，A型复合游离肉毒毒素），用于成人患者治疗慢性（长期）流涎症（chronic sialorrhea，即唾液过多、大量流口水）。
  FDA通过优先审评程序对Xeomin进行了审查。此次批准，使Xeomin成为美国市场首个也是唯一一个获批该适应症的神经毒素产品。慢性流涎症也是Xeomin在美国获批的第4种神经适应症。
  流涎症（sialorrhea）主要表现为流口水较多，这是神经系统疾病患者的常见症状，包括帕金森病（PD）、肌萎缩侧索硬化症（ALS）、脑性瘫痪（CD）以及发生了脑卒中的患者。该病可能是由于吞咽问题或面部肌肉控制问题导致口腔内难以保持唾液。
  Xeomin是一种处方药，通过注射入肌肉或腺体内发挥作用。在美国市场，Xeomin于2010年首次获批治疗成人肌张力障碍、眼睑痉挛（既往已接受艾尔建保妥适Botox[onabotulinumtoxinA，A型肉毒毒素]治疗的眼睑痉挛），之后在2015年获批治疗成人上肢痉挛。
  Xeomin的获批，是基于一项随机、双盲、安慰剂对照、多中心III期临床的数据。该研究入组了184例流涎症成人患者，36例患者接受安慰剂治疗，74例患者接受75个单位Xeomin治疗，74例患者接受100个单位Xeomin治疗。数据显示，该研究成功达到了共同主要终点：在治疗第4周，与安慰剂注射组相比，100个单位Xeomin注射组在无刺激唾液流率（uSFR）和总体改变印象量表（GICS）相对注射前基线均表现出统计学意义的显著改善（分别为：p=0.004，p=0.002）。GICS是临床医生常用的一种评估神经系统疾病治疗的评分系统。该研究中，不良事件整体发生率方面，安慰剂组和治疗组相似，没有发生新的或未预料到的不良事件。
  Merz北美公司副总裁兼神经科学负责人Kevni O'Brien表示，直到现在，还没有一种获FDA批准治疗这种疾病的药物。Xeomin的获批标志着一个重要的里程碑，将解决美国地区遭受慢性流涎症困扰的超过60万成人患者中存在的未满足医疗需求，践行了Merz公司致力于改善运动障碍患者生活的承诺。
完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3f35d6e0-3450-4abc-a0da-cc7b277e7c6e

XEOMIN® (incobotulinumtoxinA)
Uses
XEOMIN is a prescription medicine used in adults:
that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea).
that is injected into muscles and used to:
treat increased muscle stiffness in the arm because of upper limb spasticity.
treat the abnormal head position and neck pain with cervical dystonia (CD) in adults who have and have not had prior treatment with botulinum toxin.
treat abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (BOTOX®).
It is not known if XEOMIN is safe and effective in children under 18 years of age.
Warnings
XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:
Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.
Do not take XEOMIN® if you: are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport®) or have a skin infection at the planned injection site.