FDA Approves EVOXAC Oral Solution for Sjögren’s Disease

Cosette Pharmaceuticals has secured its first New Drug Application (NDA) approval from the US Food and Drug Administration (FDA) for EVOXAC oral solution, a liquid formulation of cevimeline hydrochloride for adults with Sjögren’s disease who experience dry mouth.

The approval expands the available formulations of an established medicine, potentially benefiting patients who have difficulty swallowing capsules. Cosette developed the formulation internally, taking it from initial concept through regulatory approval.

EVOXAC capsules already carry an indication for treating dry mouth symptoms in adults with Sjögren’s disease. The oral solution contains the same active ingredient, providing an alternative formulation without introducing a new therapeutic agent.

Addressing Dry Mouth in Sjögren’s Disease

Sjögren’s disease is a chronic, systemic autoimmune disorder that primarily affects moisture-producing glands, commonly causing dry eyes and dry mouth. The disease can also affect multiple organ systems and cause fatigue, joint pain and other complications.

An estimated four million Americans live with Sjögren’s disease, and approximately 90% of diagnosed patients are women, according to Cosette’s announcement.

Dry mouth can interfere with eating, speaking, swallowing and everyday activities. For patients who struggle to swallow solid oral dosage forms, a liquid formulation may improve the practicality of taking medication. However, the approval announcement does not establish that the oral solution improves symptom control, adherence or clinical outcomes compared with the capsule formulation.

Regulatory Pathway Relied on Existing Evidence

Cosette submitted the NDA through an FDA regulatory pathway that allowed the company to rely partly on existing safety and efficacy data for the approved EVOXAC capsules. This approach supported development of the new formulation without a full-scale clinical development programme, according to the company.

Cevimeline is a muscarinic receptor agonist that stimulates exocrine gland secretion, including saliva production. Its pharmacological activity provides the basis for its use in managing dry mouth associated with Sjögren’s disease.

Cosette’s Vice President of Scientific Affairs, Ravi Patel, said development required the company to address formulation challenges and generate scientific evidence to support regulatory review. The programme involved collaboration across research and development, regulatory affairs, quality and manufacturing teams.

The company has not disclosed detailed formulation data, comparative clinical outcomes, dosing instructions or additional safety findings in the supplied announcement. These details will be important for healthcare professionals assessing the practical use of the oral solution.

First NDA Approval Marks a Development Milestone

Cosette President and Chief Executive Officer Apurva Saraf described the approval as a milestone in the company’s transition from acquiring and strengthening established pharmaceutical brands to developing its own products.

The achievement demonstrates its ability to advance reformulated medicines through regulatory review. It also provides a potential route for addressing formulation-related patient needs without developing an entirely new active pharmaceutical ingredient.

Nevertheless, the clinical value of EVOXAC oral solution will depend on its approved prescribing information, formulation characteristics and availability to patients. The FDA approval itself does not establish superiority over the existing capsules.

US Launch Expected by End of 2026

Cosette expects EVOXAC oral solution to become commercially available in the United States by the end of 2026. The company plans to provide further availability information closer to launch.

The approval gives adults with Sjögren’s disease another formulation option for managing dry mouth symptoms. Its principal near-term significance is improved choice of dosage form, while its broader commercial impact will depend on launch execution, prescribing uptake and the needs of patients who have difficulty swallowing capsules.

Reference

Cosette Pharmaceuticals Announces FDA Approval of EVOXAC^® (cevimeline HCl) Oral Solution, Marking Cosette’s First New Drug Application (NDA) Approval, Cosette Pharmaceuticals, 20 October 2026