New Intraoral Patch for Canker Sores Enters Clinical Trials

SWEDEN: A promising new treatment for the painful and recurring condition known as aphthous stomatitis, or canker sores, has taken a significant step forward. Swedish startup Mucocort has received approval from the Swedish Medical Products Agency and the Swedish Ethical Review Authority to commence clinical trials for its innovative intraoral patch, M045A.

Unique Self-Absorbing Patch Design

The treatment consists of a self-absorbing patch developed by a team of distinguished Swedish professors – Mats Jontell (oral medicine and pathology), Olle Isaksson (endocrinology), and Thomas Hedner (clinical pharmacology) – led by project manager Jean Lycke. According to Mucocort, preliminary research has demonstrated the patch’s potential for providing immediate pain relief to patients suffering from aphthous stomatitis.

The biodegradable patch is designed to shield the ulcer, providing instant pain relief and promoting healing primarily through a hygroscopic effect. Once placed directly over the canker sore, the patch remains in place for three to four hours before converting into a gel that can either be swallowed or spit out. As Jean Lycke expressed, “We are pleased to soon be ready to welcome our first patient to the trial.”

Collaborative Effort and Sustainable Production

The clinical trial, expected to run for six to nine months, will be conducted in collaboration with the private dental clinic chain Oral Care AB. Meanwhile, future production of the patch will be managed by Aurena Laboratories, a strategic partner of Mucocort, with manufacturing taking place in Sweden. Lycke emphasized the importance of these partnerships, stating, “We look forward to collaborating with Oral Care, and our relationship with Aurena is excellent. Both organisations share our focus on sustainable solutions and improved care.”

Promising Prospects in Buccal Delivery Market

According to GlobalData’s medical device pipeline database, 20 buccal delivery devices are currently in various stages of development globally. These devices are designed to administer drugs within or through the buccal mucosa, offering both local and systemic pharmacological actions. Mucocort’s intraoral patch represents a promising advancement in this burgeoning field.

As the clinical trials progress, the dental community and patients alike will be eagerly anticipating the potential relief and improved quality of life this innovative treatment could provide for those suffering from the often debilitating effects of canker sores.