FDA OKs Evoxac oral solution for Sjögren’s disease dry mouth

On October 20, 2026, FDA approved Evoxac (cevimeline hydrochloride) oral solution for the treatment of dry mouth symptoms in adults with Sjögren’s disease. It contains the same active ingredient as Evoxac capsules, which are already approved for this indication. Because disease-related dryness can make swallowing difficult for some patients, the liquid formulation offers an alternative to capsule-based treatment. The product is expected to be commercially available in the US by the end of 2026.

The application relied in part on the established safety and efficacy data for previously approved Evoxac capsules, reducing the need for a full-scale clinical development program.

Safety information in the announcement reflects Evoxac labeling. The most common adverse reactions include excessive sweating, nausea, sinusitis, upper respiratory tract infection, rhinorrhea, abdominal pain, urinary tract infection, cough, and vomiting. Labeling also includes warnings regarding cardiac rhythm and heart rate abnormalities, pulmonary effects including bronchoconstriction and increased airway secretions, visual disturbances, and cholinergic adverse reactions.

Evoxac is contraindicated in patients with uncontrolled asthma, acute iritis, narrow-angle glaucoma, or hypersensitivity to cevimeline.

Source: Cosette Pharmaceuticals. (2026 Oct 20). Cosette Pharmaceuticals announces FDA approval of Evoxac (cevimeline HCl) oral solution, marking Cosette’s first New Drug Application (NDA) approval