On October 20, 2026, local time, Cosette announced that the U.S. FDA has approved Evoxac(cevimeline HCl) oral solution for the treatment of dry mouth symptoms associated with Sjögren’s disease in adults.
This oral solution was conceived and developed entirely by Cosette’s internal team from initial concept through FDA approval. It is intended to provide an alternative formulation for adults with Sjögren’s disease who have dry mouth symptoms, especially for patients who may have difficulty swallowing capsules. This is Cosette’s first New Drug Application(NDA) approval, marking an important milestone in the company’s development and demonstrating its ability to identify unmet patient needs, develop new formulations of established medicines, and successfully advance FDA approval.
Evoxac Oral Solution Safety Information
Evoxac is a prescription medicine used to treat dry mouth symptoms associated with Sjögren’s disease in adults. It is not known whether Evoxac is safe and effective in children.
Important Risk Information
Heart Rhythm and Heart Rate Problems
Healthcare providers will check for heart rhythm and heart rate problems. Tell your healthcare provider if you have dizziness, palpitations or a fast heartbeat, feeling faint or lightheaded, chest discomfort, tiredness or weakness, or shortness of breath.
Lung Problems
Evoxac may make it harder for air to pass through the airways, cause the muscles in the lungs to tighten, and increase mucus in the lungs. Tell your healthcare provider if you have trouble breathing or shortness of breath, wheezing, or increased mucus.
Vision Changes
Evoxac may cause vision changes, especially at night. Do not drive or do other dangerous activities until you know how Evoxac affects you.
Cholinergic Reactions (Nervous System Problems)
Healthcare providers will check for nervous system problems during treatment. Tell your healthcare provider if you have headache, abdominal cramps or pain, changes in blood pressure, vision changes, nausea, dizziness, tearing, vomiting, shock, sweating, diarrhea, confusion, breathing problems, fast heartbeat, or tremor. Especially tell your healthcare provider if you have heavy sweating or sweating more than normal, and drink water to stay hydrated.
Who Should Not Take Evoxac
People with certain eye conditions, such as acute iritis and narrow-angle (closed-angle) glaucoma, meaning those who do not want “pinpoint” small pupils. Evoxac can cause pupil constriction.
People who are allergic to cevimeline or any ingredient in Evoxac.
People with uncontrolled asthma.
Before Taking Evoxac
Before taking Evoxac, tell your healthcare provider if you:
Have a history of atrial fibrillation or other heart or blood vessel problems;
Have asthma, chronic bronchitis, or chronic obstructive pulmonary disease;
Have a history of kidney stones or gallstones;
Have or suspect you have hereditary CYP2D6 deficiency;
Are pregnant or plan to become pregnant. It is not known whether Evoxac will harm an unborn baby;
Are breastfeeding or plan to breastfeed. It is not known whether Evoxac passes into breast milk. Do not breastfeed during treatment and for 1 day after the last dose. Discuss with your healthcare provider the best way to feed your baby during treatment.
Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Evoxac and other medicines may affect each other and cause side effects. Know the medicines you take, and keep a list to show your healthcare providers and pharmacist when you get a new medicine.
Common Side Effects
Heavy sweating or sweating more than normal, nausea, swelling inside the nose/throat or sinuses (sinusitis), upper respiratory tract infection, runny nose, abdominal pain, urinary tract infection, cough, vomiting, injury, back pain, bronchitis, joint pain, tiredness or lack of energy (fatigue). These are not all possible side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
