5 Key Takeaways

• 1

  The FDA approved oral solution cevimeline hydrochloride for treating dry mouth in adults with Sjögren’s disease.

• 2

  The liquid formulation offers an alternative to existing cevimeline capsules for patients who have difficulty swallowing them.

• 3

  The approval relied in part on existing safety and efficacy data for cevimeline capsules and did not require a full-scale clinical development program.

• 4

  No new randomized efficacy trial or comparative data were reported, and the approval does not establish superior symptom relief with the oral solution.

• 5

  Cosette expects the oral solution to be commercially available in the United States by the end of 2026.