Cosette Pharmaceuticals Receives FDA Approval for EVOXAC® Oral Solution to Treat Dry Mouth in Adults With Sjögren’s Disease
Cosette Pharmaceuticals, Inc., a U.S.-based specialty pharmaceutical company, has 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. The approval introduces a new formulation of an established medicine intended to address the needs of patients who experience difficulty swallowing capsules.
The newly approved oral solution was conceived, developed, and advanced through regulatory review by Cosette’s internal teams, marking a significant milestone in the company’s product development capabilities. The achievement represents Cosette’s first New Drug Application (NDA) approval and demonstrates its ability to develop new formulations of existing medicines to address unmet patient needs.
EVOXAC® oral solution contains cevimeline hydrochloride, the same active ingredient used in Cosette’s previously approved EVOXAC® capsules. The capsule formulation is indicated for the treatment of symptoms of dry mouth in adults with Sjögren’s disease. By developing the medicine in an oral solution format, Cosette aims to provide an alternative administration option for patients who may find swallowing capsules challenging because of disease-associated dryness or other swallowing difficulties.
The company expects EVOXAC® oral solution to become commercially available in the United States by the end of 2026. Cosette stated that additional information about product availability will be shared closer to the anticipated launch.
First NDA Approval Marks a Milestone for Cosette Pharmaceuticals
The FDA approval represents an important development in Cosette’s evolution from a company focused on acquiring and strengthening established pharmaceutical brands to one that can also develop and advance its own products through regulatory approval.
Apurva Saraf, President and Chief Executive Officer of Cosette Pharmaceuticals, highlighted the significance of the achievement and the work performed by the company’s internal teams.
“EVOXAC® oral solution marks an important milestone for Cosette—our first NDA approval, achieved through the dedication and ingenuity of our own teams,” Saraf said.
He explained that the development reflects the company’s philosophy of “Innovating Every Day,” which involves reassessing established medicines and identifying opportunities to address practical challenges faced by patients.
According to Saraf, Cosette has built its business by acquiring and strengthening trusted pharmaceutical brands. The approval of EVOXAC® oral solution demonstrates that the company can also create value through internal research, formulation development, and regulatory expertise.
Saraf expressed pride in the employees who contributed to the product’s development and noted that the milestone creates opportunities for the company’s future product development activities.
The approval is significant not only because it expands the available formulation options for a medicine used to treat Sjögren’s-associated dry mouth, but also because it validates Cosette’s ability to navigate the regulatory process for a company-developed product.
Addressing Dry Mouth in Adults With Sjögren’s Disease
Sjögren’s disease is a chronic autoimmune condition that affects the body’s moisture-producing glands. The disease commonly causes dry eyes and dry mouth, although its effects can vary among individuals and may extend beyond these symptoms.
Dry mouth, also known as xerostomia, can affect everyday activities such as eating, speaking, and swallowing. In some patients, reduced moisture in the mouth makes it difficult to swallow solid medicines, including capsules. This can create an additional treatment burden for people who already manage persistent symptoms associated with an autoimmune disease.
For patients who experience swallowing difficulties, an oral solution may provide an alternative way to take a medicine containing an established active ingredient. Cosette developed EVOXAC® oral solution with this practical challenge in mind.
The product is intended for adults with Sjögren’s disease who require treatment for symptoms of dry mouth. It provides a liquid formulation of cevimeline hydrochloride, the active ingredient in EVOXAC® capsules.
The development of alternative formulations can be an important strategy in pharmaceutical innovation. Although a medicine’s active ingredient may already be established, changing its dosage form can help address administration difficulties and provide additional options for specific patient populations.
In this case, the oral solution is intended to address a formulation-related need without requiring the development of an entirely new active pharmaceutical ingredient.
However, the availability of a liquid formulation does not eliminate the need to assess whether the medicine is appropriate for each patient. Healthcare professionals must consider the patient’s medical history, existing conditions, concomitant medications, and the safety information included in the product’s prescribing information.
Streamlined Regulatory Pathway Supported the Approval
Cosette submitted an NDA for EVOXAC® oral solution through an FDA regulatory pathway that allowed the company to rely, in part, on existing safety and efficacy evidence for the previously approved EVOXAC® capsules.
This approach enabled the company to advance the new formulation without conducting a full-scale clinical development program. By drawing on the established body of evidence for cevimeline, Cosette was able to focus its development efforts on the requirements associated with the oral solution and the supporting scientific information needed for regulatory review.
The development process nevertheless involved significant formulation and scientific work. Creating a new dosage form requires attention to the product’s formulation characteristics, quality, manufacturing processes, and regulatory requirements.
Ravi Patel, Vice President of Scientific Affairs at Cosette Pharmaceuticals, described the work involved in developing the oral solution and supporting its FDA submission.
“Developing EVOXAC® oral solution required us to solve a complex formulation challenge and generate the scientific evidence needed to support regulatory review,” Patel said.
He explained that the company used an established regulatory pathway and existing evidence for cevimeline to pursue a focused development strategy.
Patel also emphasized the collaborative effort required to bring the product through approval, highlighting contributions from research and development, Regulatory, Quality, Manufacturing, and other functions within the organization.
The milestone reflects the importance of coordination across pharmaceutical development teams, particularly when a company seeks to modify an established medicine’s formulation while meeting applicable regulatory standards.
The approval also demonstrates how formulation development can offer a route to product innovation when an established medicine has a known therapeutic use but a different administration format could better accommodate certain patient needs.
Important Safety Information for EVOXAC®
Although EVOXAC® oral solution offers an alternative formulation, the medicine retains important safety considerations associated with cevimeline. Patients and healthcare professionals should review the full prescribing information before treatment.
EVOXAC is a prescription medicine used to treat symptoms of dry mouth in adults with Sjögren’s disease. Its safety and effectiveness in children have not been established.
The prescribing information identifies several potentially serious risks that require attention during treatment.
Heart rhythm and heart rate problems
EVOXAC may cause heart rhythm or heart rate problems. Patients should tell their healthcare provider if they experience dizziness, a pounding or racing heartbeat, faintness, lightheadedness, chest discomfort, unusual tiredness, weakness, or shortness of breath.
Healthcare professionals should assess relevant symptoms and monitor patients as appropriate, particularly when there is a history of cardiovascular disease or heart rhythm disturbances.
Lung and breathing problems
The medicine can make it more difficult for air to move through the airways, cause the muscles in the lungs to tighten, and increase mucus production.
Patients should seek medical advice if they develop difficulty breathing, shortness of breath, wheezing, or increased mucus. These risks are particularly relevant for individuals with certain underlying respiratory conditions.
Changes in vision
EVOXAC may cause changes in vision, especially at night. Patients should avoid driving or performing hazardous activities until they understand how the medicine affects their vision and ability to carry out these activities safely.
Cholinergic reactions
EVOXAC can cause cholinergic reactions involving the nervous system and other bodily functions. Potential symptoms include headache, abdominal cramping or pain, changes in blood pressure, vision changes, nausea, dizziness, watery eyes, vomiting, sweating, diarrhea, confusion, breathing difficulties, rapid heartbeat, and tremors. Severe reactions may require urgent medical attention.
Heavy sweating or sweating more than usual is an important potential effect. Patients should maintain adequate fluid intake to help prevent dehydration and discuss excessive sweating with their healthcare provider.
These warnings do not represent every possible risk associated with treatment. Patients should consult their healthcare provider about symptoms that arise during therapy.
Who Should Not Take EVOXAC?
According to the supplied prescribing information, EVOXAC should not be taken by individuals with certain medical conditions or allergies.
The medicine is contraindicated in patients with acute iritis or narrow-angle, also known as angle-closure, glaucoma when pupil constriction is undesirable. Cevimeline can cause the pupils to constrict, which may be inappropriate for patients with these eye conditions.
Patients who are allergic to cevimeline or any ingredient in EVOXAC should not take the medicine. It is also contraindicated in people with uncontrolled asthma.
Before starting treatment, patients should inform their healthcare provider if they have a history of atrial fibrillation or other heart and blood vessel problems. Information about asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), kidney stones, gallstones, or suspected CYP2D6 deficiency should also be discussed.
Patients who are pregnant or planning to become pregnant should speak with their healthcare provider because it is not known whether EVOXAC can harm an unborn baby.
Breastfeeding also requires careful consideration. The supplied prescribing information states that it is not known whether EVOXAC passes into breast milk and advises patients not to breastfeed during treatment and for one day after the last dose. Patients should discuss appropriate infant-feeding arrangements with their healthcare provider.
Patients must also disclose all prescription and over-the-counter medicines, vitamins, and herbal supplements they take. EVOXAC may interact with other medicines, potentially affecting safety or increasing the risk of adverse effects. Maintaining an up-to-date medication list can help healthcare professionals assess potential interactions.
Common Side Effects and Adverse Event Reporting
The most common side effects listed for EVOXAC include heavy sweating or sweating more than usual, nausea, sinusitis, upper respiratory tract infection, runny nose, abdominal pain, urinary tract infection, coughing, vomiting, injury, back pain, bronchitis, joint pain or arthralgia, and fatigue.
This list is not exhaustive, and individual experiences may vary. Patients should contact their healthcare provider if they develop side effects that are bothersome, persistent, or concerning.
Suspected adverse reactions can be reported to Cosette Pharmaceuticals at 1-800-922-1038 or to the FDA at 1-800-FDA-1088. Reports can also be submitted through the FDA MedWatch program.
Patients and healthcare professionals should consult the full prescribing information for EVOXAC for complete details regarding indications, contraindications, warnings, precautions, interactions, and adverse reactions.
Anticipated U.S. Launch by the End of 2026
Cosette Pharmaceuticals expects EVOXAC® oral solution to be commercially available in the United States by the end of 2026. The company plans to communicate additional information about availability closer to the launch date.
The approval represents a dual milestone for Cosette: it introduces a new formulation option for adults with Sjögren’s disease who experience dry mouth and establishes the company’s first NDA approval for a product developed by its internal teams.
By combining an established active ingredient with an alternative dosage form, Cosette has sought to address a specific administration challenge while building its internal product development capabilities.
As the anticipated launch approaches, the practical impact of EVOXAC® oral solution will depend on commercial availability, prescribing decisions, and individual patient suitability. For adults living with Sjögren’s disease, the approval provides an additional formulation option to discuss with healthcare professionals when managing symptoms of dry mouth.
For Cosette, the achievement demonstrates the potential of internal formulation development to complement its established-brand business and support future pharmaceutical innovation.
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).