FDA greenlights liquid Evoxac for Sjögren's patients who struggle to swallow capsules

The FDA has approved Evoxac oral solution (cevimeline HCl), a liquid formulation of the already-approved Evoxac capsule, for treating dry mouth symptoms in adults with Sjögren's disease. Developed by Cosette Pharmaceuticals, the new formulation is specifically aimed at patients who have difficulty swallowing capsules — a common challenge in this population. It marks Cosette's first-ever new drug application (NDA) approval and is expected to be commercially available by the end of 2026.

The approval was granted through a streamlined regulatory pathway that allowed Cosette to leverage existing safety and efficacy data from the original capsule formulation, bypassing the need for a full-scale clinical development program. The active ingredient remains the same; only the delivery format has changed.

Key Takeaways:

• Evoxac oral solution contains the same active ingredient (cevimeline HCl) as the capsule, just in a more accessible liquid form
• Approved via an expedited pathway using existing clinical data — no new large-scale trials were required
• The Sjögren's Foundation welcomed the approval, noting that flexible treatment options are critical since the disease manifests differently in each patient

Why it matters: Dry mouth in Sjögren's disease can significantly affect daily life — from eating and speaking to oral health. Giving patients and providers a liquid option expands access and personalization of care for a condition that often requires individualized management.