FDA批准首款西维美林口服液：为吞咽困难的干燥综合征患者提供新选择
美国食品药品监管局（FDA）已批准 Evoxac（盐酸西维美林）口服液上市，用于治疗成年干燥综合征患者的口干症状。制药商 Cosette Pharmaceuticals 于 10 月 20 日宣布了这一消息；这是这家位于 New Jersey 州 Bridgewater 的 specialty 药企获得的首个新药申请（NDA）批准。
新获批的口服液规格为每 5 毫升含西维美林 30 毫克，覆盆子口味，以 473 毫升瓶装供应。西维美林胶囊剂早在 2000 年即获 FDA 批准用于同一适应症；Cosette 表示，口服液是为吞咽胶囊有困难的患者设计的替代剂型。
西维美林是一种胆碱能激动剂，通过与外分泌腺上的毒蕈碱受体结合，促进唾液腺等腺体分泌。口服液的推荐剂量为每次 30 毫克（5 毫升）、每日三次，配一杯水送服，可与食物同服或空腹服用。
此次批准部分依据西维美林胶囊剂此前的三项安慰剂对照试验数据，以及一项在干燥综合征患者中开展的生物利用度研究——该研究显示口服液与胶囊的生物利用度相当，30 毫克剂量服药后平均达峰时间约为 1.7 小时。Cosette 科学事务副总裁 Ravi Patel 表示，开发口服液需要攻克复杂的制剂难题，并生成支持监管审评的科学证据。
根据药品说明书，30 毫克剂量组最常见的不良反应包括多汗（18.7%）、恶心（13.8%）、鼻窦炎（12.3%）与鼻炎（11.2%）。该药禁用于未受控制的哮喘患者、对西维美林过敏者，以及急性虹膜炎、窄角型青光眼等不适宜缩瞳的情形。
Cosette 预计，Evoxac 口服液将于 2026 年底前在美国上市销售，具体供应细节将在临近上市时公布。干燥综合征是一种自身免疫性疾病，患者的外分泌腺受损，常表现为口干、眼干等症状。
FDA Approves First Cevimeline Oral Solution for Dry Mouth in Sjögren Disease
The U.S. Food and Drug Administration (FDA) has approved Evoxac (cevimeline hydrochloride) oral solution for the treatment of dry mouth symptoms in adults with Sjögren disease. Cosette Pharmaceuticals announced the approval on October 20, calling it the first New Drug Application (NDA) approval for the Bridgewater, New Jersey-based specialty pharmaceutical company.
The oral solution contains 30 mg of cevimeline per 5 mL, is raspberry-flavored, and is supplied in 473-mL bottles. Cevimeline capsules were first approved by the FDA in 2000 for the same indication; Cosette designed the oral solution as an alternative for patients who have difficulty swallowing capsules.
Cevimeline is a cholinergic agonist that binds to muscarinic receptors in exocrine glands, increasing secretion from glands including the salivary glands. The recommended dosage of the oral solution is 30 mg (5 mL) three times daily, taken with a glass of water, with or without food.
The approval relied in part on efficacy and safety data from three placebo-controlled trials of cevimeline capsules, along with a bioavailability study in patients with Sjögren disease showing comparable bioavailability between the two formulations, with a mean time to peak concentration of 1.7 hours after a 30-mg dose. Ravi Patel, vice president of scientific affairs at Cosette, said developing the oral solution required solving a complex formulation challenge and generating the scientific evidence needed to support regulatory review.
According to the prescribing information, the most common adverse reactions at the 30-mg dose included excessive sweating (18.7%), nausea (13.8%), sinusitis (12.3%) and rhinitis (11.2%). The drug is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and conditions in which miosis is undesirable, such as acute iritis and narrow-angle glaucoma.
Cosette expects the oral solution to be commercially available in the United States by the end of 2026, with additional availability details to be shared closer to launch. Sjögren disease is an autoimmune condition that damages the exocrine glands, commonly causing dry mouth and dry eyes.
发布：GSM·美国（发布链接）
图片来源：图：口干症医学示意图：舌面干燥是干燥综合征患者口干症状的典型表现。西维美林通过刺激唾液腺等外分泌腺分泌，缓解口干症状。图片：Scientific Animations，CC BY-SA 4.0，经维基共享资源。Image: Medical illustration of xerostomia (dry mouth), the hallmark symptom treated in Sjögren syndrome patients. Cevimeline works by stimulating exocrine glands including the salivary glands. By Scientific Animations, CC BY-SA 4.0, via Wikimedia Commons.
GSM Global · 本篇英文版 English edition of this story
