The US Food and Drug Administration (FDA) has approved Evoxac (cevimeline HCI) oral solution to address dry mouth in patients with Sjögren’s disease (SjD).
SjD is an autoimmune disorder that largely impacts secretory glands. It is also associated with rheumatic disorders such as rheumatoid arthritis or systemic lupus erythematosus. Hallmark symptoms include dry mouth and dry eyes, but the condition may cause skin, nose, and vaginal dryness. SjD may also affect other organs of the body including the kidneys, blood vessels, lungs, liver, pancreas, and brain.
Cevimeline is a direct-acting cholinergic receptor (mucarinic) agonist. The new oral solution is designed to offer an alternate formula, providing patients with choices in their treatment plan, including those who have difficulty swallowing pills.
Cevimeline (capsule formulation) was first approved in 2000 for Daiichi Sankyo. The approval for the new liquid formation with Cosette Pharmaceuticals was made possible via a more streamlined FDA process that included the existing safety and efficacy data from that earlier review of the capsule formulation.
For more information, visit https://cosettepharma.com/cosette-pharmaceuticals-announces-fda-approval-of-evoxac-cevimeline-hcl-oral-solution-marking-cosettes-first-new-drug-application-nda-approval/
To learn more about SjD and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-autoinflammatory-disorders/