Cosette Pharmaceuticals Announces FDA Approval of EVOXAC® (cevimeline HCl) Oral Solution, Marking Cosette’s First New Drug Application (NDA) Approval

The approval marks Cosette’s first successful New Drug Application for a product developed by its internal teams.

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– – New Oral Solution Formulation Developed for Patients Living with Sjögren’s Disease demonstrates Cosette's expanding capabilities in product development and innovation – –

– – Product Expected to be Commercially Available by the end of 2026 – –

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Cosette Pharmaceuticals, Inc. (“Cosette”), a U.S.-based specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved EVOXAC^® (cevimeline HCl) oral solution for the treatment of symptoms of dry mouth in adults with Sjögren’s disease.

EVOXAC (cevimeline HCl) oral solution logo

Conceived and developed by Cosette’s internal teams, from initial concept through FDA approval, EVOXAC^® oral solution was designed to offer an alternative formulation for adults living with Sjögren’s disease who experience symptoms of dry mouth, including those who may have difficulty swallowing capsules. As Cosette’s first New Drug Application (NDA) approval, this achievement marks an important milestone in the company’s evolution, demonstrating its ability to identify unmet patient needs, develop new formulations of established medicines, and successfully bring them through FDA approval.

“EVOXAC^® oral solution marks an important milestone for Cosette—our first NDA approval, achieved through the dedication and ingenuity of our own teams,” said Apurva Saraf, President and Chief Executive Officer of Cosette Pharmaceuticals. “It brings to life what we mean by Innovating Every Day: looking at established medicines in new ways to address real patient needs. We have built Cosette by acquiring and strengthening trusted brands. Today, we are demonstrating that we can also create value through our own product development capabilities. I am incredibly proud of our teams and excited about what this achievement makes possible for the patients’ and our future.”

Sjögren’s is a chronic autoimmune disease that affects the body's moisture-producing glands, commonly resulting in dry eyes and dry mouth. For some patients, the dryness associated with the disease can also make swallowing difficult, creating additional challenges when taking medications in capsule form.

EVOXAC^® oral solution was developed as an oral solution formulation of cevimeline hydrochloride, the same active ingredient in EVOXAC^® capsules, which are indicated for the treatment of symptoms of dry mouth in adults with Sjögren’s disease.

Cosette submitted an NDA for EVOXAC^® oral solution through a streamlined FDA-approval process, which permits applicants to rely, in part, on existing safety and efficacy data for Cosette’s previously approved EVOXAC^® capsules. This approach enabled Cosette to advance the new formulation without conducting a full-scale clinical development program.

“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 at 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. This achievement reflects years of scientific work and collaboration across R&D, Regulatory, Quality, Manufacturing and other functions, and I'm incredibly proud of everyone who contributed.”

EVOXAC^® oral solution is expected to be commercially available in the United States by the end of 2026. Additional information regarding availability will be shared closer to launch.

About EVOXAC^® Oral Solution

What is EVOXAC?

EVOXAC is a prescription medicine used to treat the symptoms of dry mouth in adults with Sjögren’s disease. It is not known if EVOXAC is safe and effective in children.

What is the most important information I should know?

Heart rhythm and heart rate problems. Your healthcare provider will check you for heart rhythm and heart rate problems. Tell your healthcare provider if you get dizziness, a feeling that your heart is pounding or racing, feeling faint or lightheaded, chest discomfort, tiredness or weakness, or shortness of breath.

Lung problems. EVOXAC can make it harder for air to move through your airways, cause the muscles in your lungs to tighten, and increase the amount of mucus in your lungs. Tell your healthcare provider if you develop trouble breathing or shortness of breath, wheezing, or increased mucus.

Changes in vision. EVOXAC may cause changes in vision, especially at night. Do not drive or do other hazardous activities until you know how EVOXAC affects you.

Cholinergic reactions (nervous system problems). Your healthcare provider will check you for nervous system problems during treatment with EVOXAC. Tell your healthcare provider if you get headache, stomach (abdominal) cramping or pain, change in blood pressure, change in vision, nausea, dizziness, watery eyes, vomiting, shock, sweating, diarrhea, confusion, breathing problems, fast heartbeat, or tremors. Especially tell your healthcare provider if you develop heavy sweating or sweat more than normal and drink fluids to keep hydrated.

Who should not take EVOXAC?

Do not take EVOXAC if you:

• have certain eye conditions such as acute iritis and narrow-angle (angle-closure) glaucoma, in which a small “pinpoint” pupil is not wanted. EVOXAC can cause tightening (constriction) of your eye pupils.
• are allergic to cevimeline or any of the ingredients in EVOXAC.
• have uncontrolled asthma.

Before taking EVOXAC, tell your healthcare provider if you:

• have a history of a heart rhythm problem called atrial fibrillation or other heart or blood vessel problems.
• have asthma, long-term (chronic) bronchitis, or chronic obstructive pulmonary disease.
• have a history of kidney stones or gallstones.
• have or think you have an inherited condition called CYP2D6 deficiency.
• are pregnant or plan to become pregnant. It is not known if EVOXAC will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if EVOXAC passes into your breast milk. Do not breastfeed during treatment with EVOXAC and for 1 day after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with EVOXAC.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. EVOXAC and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the most common side effects of EVOXAC?

The most common side effects of EVOXAC include:

• heavy sweating or sweating more than normal
• nausea
• swelling of the inside of your nose, throat or sinuses (sinusitis)
• upper respiratory tract infection
• runny nose
• stomach area (abdominal) pain
• urinary tract infection
• coughing
• vomiting
• injury
• back pain
• bronchitis
• joint pain (arthralgia)
• tired or lack of energy (fatigue)

These are not all of the possible side effects of EVOXAC.

Reporting side effects.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

To report suspected adverse reactions, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088, or visit FDA MedWatch.

Please see the Full Prescribing Information for EVOXAC.

About Sjögren’s Disease

Sjögren’s disease is a chronic, systemic autoimmune disease that affects an estimated four million Americans, approximately 90% of diagnosed patients being women. While commonly associated with dry eyes and dry mouth, Sjögren’s can affect multiple organs and systems throughout the body, causing symptoms such as fatigue, joint pain and other potentially serious complications. Dry mouth is a common symptom of Sjögren’s and can significantly affect patients’ daily lives and quality of life.¹

About Cosette

Cosette Pharmaceuticals, Inc. is a U.S.-based, leading specialty pharmaceutical company providing some of the most trusted and well-known brands in medicine — developing, manufacturing, and delivering products that make a difference in patients’ lives. Cosette’s strong growth has been driven by its proven ability to maximize the value of its portfolio through best-in-class marketing, promotion, and strategic distribution capabilities, enabling the company to scale efficiently while continuing to invest in high-quality, patient-centered therapies. Cosette has corporate headquarters in Bridgewater, New Jersey and is supported by 350+ dedicated team members across all functional areas. Cosette is backed by Avista Healthcare Partners, a healthcare focused private equity firm, and funds managed by Hamilton Lane, a private markets investment management firm (Nasdaq: HLNE). For more information, please visit www.cosettepharma.com or follow Cosette on LinkedIn.

References:

1. Sjögren’s Foundation. “Understanding Sjögren’s.” Accessed October 2026. sjogrens.org/understanding-sjogrens

 

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Cosette Pharmaceuticals Media Contact
media@cosettepharma.com

Source: Cosette Pharmaceuticals, Inc.

Key Terms

new drug application (nda) regulatory

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

atrial fibrillation medical

Atrial fibrillation is a common heart rhythm problem in which the heart’s upper chambers quiver instead of delivering steady, strong pumps, like a washing machine on an unbalanced cycle. It matters to investors because it increases use of medications, medical devices, hospital care and long‑term monitoring, drives demand for new treatments and diagnostics, and can affect healthcare costs, regulatory decisions and revenue prospects across drug, device and insurance markets.

cyp2d6 deficiency medical

A genetically or drug-induced reduction or loss of activity of the liver enzyme CYP2D6, which metabolizes many prescription drugs. CYP2D6 deficiency usually results from inherited gene variants (including nonfunctional alleles or gene deletions) or from strong enzyme inhibitors and produces a “poor metabolizer” or intermediate metabolizer phenotype that changes how quickly affected individuals clear drugs that are CYP2D6 substrates, potentially altering drug levels and effects. It is a metabolic phenotype, not a disease diagnosis; testing identifies genotype or phenotype to predict enzyme activity.

cholinergic reactions medical

A set of signs and symptoms produced when the nervous system is exposed to excess acetylcholine or drugs that mimic it, causing overstimulation of cholinergic (muscarinic and nicotinic) receptors. Common features from muscarinic overstimulation include increased saliva and tears, sweating, slow heart rate, constricted pupils, and increased bronchial secretions; nicotinic effects include muscle twitching, weakness or paralysis; severe reactions can cause breathing failure. Cholinergic reactions are classically seen after exposure to cholinesterase inhibitors (including some pesticides and certain medicines) or direct cholinergic agonists and reflect the underlying receptor-specific effects rather than a single symptom profile.