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.
Published by GSM · USA (original Chinese edition)
Photo: 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.
