FDA Approves Cevimeline Oral Solution for Dry Mouth in Sjögren Disease

The US Food and Drug Administration (FDA) has approved cevimeline hydrochloride oral solution (Evoxac) for the treatment of symptoms of dry mouth in adults with Sjögren disease, according to an October 20, 2026, announcement from Cosette Pharmaceuticals.¹

The new formulation contains the same active ingredient as cevimeline capsules, a cholinergic agonist first approved by the FDA in 2000 for the same indication.² Cosette designed the oral solution as an alternative for adults who have difficulty swallowing capsules.¹ The approval is the first New Drug Application (NDA) approval for the Bridgewater, New Jersey-based specialty pharmaceutical company.¹

"Developing Evoxac oral solution required us to solve a complex formulation challenge and generate the scientific evidence needed to support regulatory review," said Ravi Patel, vice president, Scientific Affairs, Cosette Pharmaceuticals. "By leveraging an established regulatory pathway and the existing body of evidence for cevimeline, our teams were able to take a focused approach to development."

Cevimeline oral solution approval pathway and efficacy data

According to Cosette, the company submitted the NDA through a streamlined regulatory pathway permitting it to rely in part on existing safety and efficacy data for the previously approved capsules.¹ The approach allowed the oral solution to advance without a full-scale clinical development program.¹ In a bioavailability study conducted in patients with Sjögren disease, the oral solution showed comparable bioavailability to the capsules, with a mean time to peak concentration of 1.7 hours after a 30-mg (5-mL) dose followed by a glass of water.²

The label carries efficacy data from 3 randomized, double-blind, placebo-controlled trials of cevimeline capsules.² In Trial 1, a 6-week study of 75 adults, 76% of patients receiving cevimeline 30 mg 3 times daily reported global improvement in dry mouth symptoms compared with 35% of patients receiving placebo (P = .0043).² Trial 2, a 12-week study of 197 adults, also showed significant global improvement with the 30-mg dose vs placebo (P = .0004), along with significant increases in salivary flow.²

Trial 3, a 12-week study of 212 adults, did not show a statistically significant difference in patient global evaluations, and the label notes a higher placebo response rate in this trial compared with Trials 1 and 2.² However, the 30-mg dose produced a significant increase in salivary flow from predose to postdose compared with placebo (P = .0017).² Higher dosing did not add benefit, as patients receiving 60 mg 3 times daily in Trial 1 did not report better global evaluation scores than those receiving 30 mg.²

Cevimeline dosing and safety profile in Sjögren disease

The recommended dosage of the oral solution is 30 mg (5 mL) 3 times daily taken with a glass of water, with or without food.² The raspberry-flavored solution is supplied at 30 mg per 5 mL in 473-mL bottles.² Per the label, patients should not double a missed dose and should wait for the next scheduled dose if fewer than 4 hours remain.²

Safety for the oral solution was established from the capsule trials, which enrolled 320 adults across dosages ranging from 15 mg to 60 mg 3 times daily.² In these trials, 14.6% of patients discontinued treatment due to adverse events.² The most common adverse reactions with the 30-mg dose (n = 533) vs placebo (n = 164) included excessive sweating (18.7% vs 2.4%), nausea (13.8% vs 7.9%), sinusitis (12.3% vs 10.9%), and rhinitis (11.2% vs 5.4%).²

Cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, or conditions in which miosis is undesirable, such as acute iritis and narrow-angle glaucoma.² Warnings address cardiovascular, pulmonary, ophthalmic, and cholinergic adverse reactions, with close monitoring advised for patients with a history of nephrolithiasis or cholelithiasis.² The label also calls for close monitoring of patients with known or suspected CYP2D6 deficiency and those taking CYP2D6 or CYP3A3/4 inhibitors, beta-adrenergic antagonists, or other cholinergic agonists.²

Cosette expects the oral solution to be commercially available in the US by the end of 2026, with additional availability details to be shared closer to launch.¹

References

1. Cosette Pharmaceuticals. Cosette Pharmaceuticals announces FDA approval of EVOXAC (cevimeline HCl) oral solution, marking Cosette's first New Drug Application (NDA) approval. Published October 20, 2026. Accessed October 20, 2026. https://www.businesswire.com/news/home/20261020345996/en/Cosette-Pharmaceuticals-Announces-FDA-Approval-of-EVOXAC-cevimeline-HCl-Oral-Solution-Marking-Cosettes-First-New-Drug-Application-NDA-Approval

2. Evoxac (cevimeline hydrochloride) capsules and oral solution. Prescribing information. Cosette Pharmaceuticals, Inc; 2026. Accessed October 20, 2026. https://evoxac.com/wp-content/uploads/2026/10/Evoxac-Oral-Solution-Prescribing-Information.pdf