外泌汗腺位于真皮内，主要受胆碱能神经分泌乙酰胆碱递质支配，分泌物以水为主。很多患者在睡觉、休息、放松等交感神经不兴奋时则是不出汗的，一运动或者紧张等交感神经兴奋时，其功能亢进，就会分泌出很多的汗液，我们称之为“多汗症”。顶泌汗腺主要位于皮下浅层，紧邻真皮，其除了受胆碱能神经支配外，还受其它肾上腺素能神经支配，主要分泌一些不饱和或羟基化的支链脂肪酸，这些物质被分泌至皮肤表面，被细菌分解后可具有特殊气味，严重的时候可影响到人们的生活和日常交往。

2018年6月30日,Dermira制药公司宣布，美国食品和药物管理局（FDA）已批准Qbrexza（glycopyrronium tosylate，葡萄糖吡喀甲磺酸盐）Cloth，用于9岁及以上儿童和成人，治疗原发性腋窝多汗症（Primary Axillary Hyperhidrosis）。

此次批准，使Qbrexza成为首个获FDA批准治疗腋下多汗症的每日一次局部擦拭药物。腋下多汗症，也被称为腋下出汗过度，是一种常见的慢性皮肤病，影响美国约1000万人，男女患病率相似。Qbrexza是一种抗胆碱能药物，可直接应用于腋下，可通过抑制汗腺激活来阻止汗液产生。Dermira计划在2018年10月将Qbrexza推向美国市场。

多汗症是指出汗超过正常体温调节生理学需求的一种疾病，影响美国约4.8%人口，或大约1500万人。研究表明，过度出汗常会妨碍正常的日常活动，也会导致职业、情绪、心理、社会和身体上的损害。若出汗过多的原因无法查明，则被归为原发性多汗症范畴。若是因一种内在病症而大量出汗，则称为继发性多汗症。若是腋下出汗过多，但又找不到原因，则称为原发性腋窝多汗症。

Qbrexza旨在通过抑制乙酰胆碱与负责汗腺激活的胆碱能受体之间的相互作用来阻止汗液的产生。

U.S. Food and Drug Administration (FDA) has approved Qbrexza™ (glycopyrronium) cloth, an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.

Primary axillary hyperhidrosis, also commonly known as excessive underarm sweating, is a chronic medical skin condition that results in sweating beyond what is needed for normal body temperature regulation. The exact cause is unknown, but it affects nearly 10 million people in the United States, with both men and women having similar preva lence. Qbrexza (pronounced kew brex’ zah) is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation.

“For years, dermatologists have been telling us of the need for new treatment options that address primary axillary hyperhidrosis given the stigma and burden associated with this condition,” said Tom Wiggans, chairman and chief executive officer at Dermira. “From the start, our goal was to develop an approach that went beyond masking a person’s excessive underarm sweating and instead focused on treating the condition in a clinically meaningful way. We partnered with dermatologists and the FDA during the development stage and listened to the people who have been living with this condition to understand how they would define a meaningful benefit. It is our hope that Qbrexza will not only provide the clinical benefit these sufferers have been seeking, but help to reduce the overall burden on their lives.”

The approval is based on results from two Phase 3 clinical trials, ATMOS-1 and ATMOS-2, which eva luated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis. Both trials assessed the absolute change from baseline in sweat production (the weight or amount of sweat a patient produced) following treatment with Qbrexza and the proportion of patients who achieved at least a four-point improvement from baseline in their sweating severity, as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument. The PRO was developed in consultation with the FDA and in accordance with the agency’s 2009 guidance on PRO instruments.

Dermira Receives FDA Approval for Qbrexza™ (glycopyrronium) Cloth to Treat Primary Axillary Hyperhidrosis