FDA approves liquid cevimeline for Sjögren’s disease

The new oral solution offers an alternative to capsules for adults with dry mouth, including those with swallowing difficulties.

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The FDA approved oral solution cevimeline hydrochloride for treating dry mouth in adults with Sjögren’s disease.
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The liquid formulation offers an alternative to existing cevimeline capsules for patients who have difficulty swallowing them.
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The approval relied in part on existing safety and efficacy data for cevimeline capsules and did not require a full-scale clinical development program.
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No new randomized efficacy trial or comparative data were reported, and the approval does not establish superior symptom relief with the oral solution.
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Cosette expects the oral solution to be commercially available in the United States by the end of 2026.

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