An Unmet Clinical Need

Xerostomia, known as dry mouth, is a medical condition caused by salivary gland dysfunction, often triggered by radiation therapy for head and neck cancer, autoimmune diseases or aging. Dry mouth has been reported to affect over 8 million people in the U.S. alone, up to 1 in 4 adults over 50, with severity ranging from mild to significant¹. Patients suffering from dry mouth often experience a burning sensation in the mouth, dental decay, difficulty chewing, swallowing, tasting, speaking, sore throat, dry lips and tongue, mouth sores, halitosis and much more. These symptoms can make basic tasks such as communication and eating incredibly difficult and a constant battle. Although dry mouth affects 8 million patients worldwide, it remains one of the most overlooked, underdiagnosed, and poorly managed oral health conditions². Despite the significant burden Xerostomia places on patients, the market for effective treatments remains remarkably underdeveloped, with limited viable options.

Competitive Market Assessment

The current standard of care for managing dry mouth includes FDA-approved oral medications cevimeline (Evoxac™) and pilocarpine (Salagen™), which increase glandular secretion systemically. These medications are known as sialogogues and have short half-lives (3 and 5 hours, respectively) requiring dosing 3-5 times per day³. The disruptive schedule and systemic side effects significantly reduce adherence to these oral sialogogues. One physician noted, “I’ll prescribe pilocarpine because I can assume patients will develop dry mouth after radiation treatment, though almost no patients report being satisfied or experiencing relief.” Many patients have resorted to over-the-counter Biotene™ products such as oral rinses, lozenges, and mouth sprays, but one patient reported, “None of the products have been effective—they work on a limited basis and are not worth it.” Additionally, there are no regenerative therapies that aim to permanently treat dry mouth symptoms by restoring salivary gland function, unlike Hydronovo’s ceviginate.

Ceviginate was specifically developed to overcome the shortcomings of existing therapies, which, due to their short half-life, inconvenient dosing schedules, and lack of regenerative properties, fail to provide meaningful relief. As a result, many dry mouth patients rely on palliative care rather than a true therapeutic solution. By directly addressing the limitations of existing therapies, ceviginate is positioned to be the first treatment designed to meet patient needs with both efficacy and long-term impact.

References:

1. Tanasiewicz M, Hildebrandt T, Obersztyn I. Xerostomia of Various Etiologies: A Review of the Literature. Adv Clin Exp Med Off Organ Wroclaw Med Univ 2016;25:199–206. https://doi.org/10.17219/acem/29375. 

2. Frydrych AM. Dry mouth: Xerostomia and salivary gland hypofunction. Aust Fam Physician 2016;45:488–92. 

3. Weber J, Keating GM. Cevimeline. Drugs 2008;68:1691–8. https://doi.org/10.2165/00003495-200868120-00006.