Cosette Pharmaceuticals has received FDA approval for EVOXAC (cevimeline HCl) oral solution, a new formulation intended to treat dry mouth symptoms in adults with Sjögren’s disease. The approval marks the specialty pharmaceutical company’s first approved New Drug Application (NDA) developed through its own product development efforts. The oral solution offers an alternative to the existing EVOXAC capsule formulation, particularly for patients who experience difficulty swallowing solid dosage forms. Both formulations contain cevimeline hydrochloride, which is indicated for the treatment of dry mouth symptoms associated with Sjögren’s disease.

Sjögren’s disease is a chronic autoimmune condition that affects the body’s moisture-producing glands. Common symptoms include dry eyes and dry mouth, with some patients experiencing swallowing difficulties that can complicate medication administration. Cosette developed the new formulation internally, taking the product from initial concept through regulatory approval. The achievement demonstrates the company’s expanding capabilities in formulation development and its strategy of creating new product opportunities by addressing unmet patient needs.

“EVOXAC oral solution marks an important milestone for Cosette — our first NDA approval, achieved through the dedication and ingenuity of our own teams,”

says Apurva Saraf, president and CEO of Cosette Pharmaceuticals. He said the approval reflects the company’s ability to develop new formulations of established medicines in addition to acquiring and expanding existing pharmaceutical brands.

The company pursued a streamlined FDA regulatory pathway for the oral solution, allowing it to rely in part on existing safety and efficacy data for the previously approved EVOXAC capsules. This approach enabled development of the new formulation without requiring a full-scale clinical development program.

According to Ravi Patel, vice president of scientific affairs at Cosette, the project involved addressing formulation challenges and assembling the scientific evidence required for regulatory review. He credits collaboration across research and development, regulatory affairs, quality, and manufacturing teams for bringing the product through the approval process.

Cosette expects EVOXAC oral solution to become commercially available in the United States by the end of 2026. The company said it will provide further details about availability closer to launch. The approval represents a step forward in Cosette’s efforts to build its internal research and development capabilities, with the new formulation providing another option for adults managing dry mouth symptoms associated with Sjögren’s disease.

For more information, visit www.cosettepharma.com.