The US Food and Drug Administration (FDA) has approved a new oral solution formulation of cevimeline hydrochloride (Evoxac) for treating dry mouth in adults with Sjögren’s disease, providing an alternative formulation for patients who have difficulty swallowing capsules, according to a Cosette Pharmaceuticals press release.
The approval introduces a liquid formulation of an established medication rather than a new active ingredient or treatment indication. Cevimeline hydrochloride is already available in capsule form for the same patient population.
The oral solution was developed to address administration challenges associated with Sjögren’s disease, which affects moisture-producing glands and can cause persistent oral dryness. According to Cosette, patients whose symptoms make swallowing capsules difficult may benefit from the alternative formulation.
The approval was granted through a streamlined New Drug Application pathway that allowed Cosette to rely in part on existing safety and efficacy data for previously approved cevimeline capsules. The company reported that this approach did not require a full-scale clinical development program for the oral solution.
Cosette also did not disclose results from a new randomized efficacy trial, comparative effectiveness data, or evidence demonstrating superior symptom relief with the liquid formulation. The approval therefore expands available administration options without establishing an efficacy advantage over cevimeline capsules.
Cevimeline stimulates muscarinic receptors to increase exocrine gland secretions, including saliva. Its established indication addresses symptomatic dry mouth rather than the underlying autoimmune disease.
Important safety considerations include potential cardiac rhythm and heart rate disturbances, bronchoconstriction, increased respiratory secretions, and visual disturbances, particularly during nighttime activities. Cholinergic adverse reactions may also occur, including excessive sweating, nausea, abdominal discomfort, dizziness, and diarrhea. Patients experiencing increased sweating should maintain adequate hydration.
Cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to the medication, or conditions in which pupillary constriction is undesirable, including acute iritis and narrow-angle glaucoma.
Additional precautions apply to patients with cardiovascular disease, obstructive pulmonary conditions, or a history of kidney stones or gallstones. The company noted clinicians should review concomitant medications and monitor for cardiovascular, respiratory, and cholinergic adverse reactions during treatment.
Cosette expects the oral solution to become commercially available in the United States by the end of 2026. The announcement did not specify the new formulation's concentration, dosing instructions, or price.
Source: Cosette Pharmaceuticals
