Swedish startup Mucocort has received approval from the Swedish Medical Products Agency and the Swedish Ethical Review Authority to commence a clinical trial assessing its intraoral patch for the treatment of aphthous stomatitis.
The condition, which is more commonly known as canker sores, results in frequent mouth ulcers with significant pain for affected patients.
Mucocort's treatment consists of a self-absorbing patch (M045A) developed by Mats Jontell, professor in oral medicine, and pathology; Olle Isaksson, professor in endocrinology; and Thomas Hedner, professor in clinical pharmacology, with Jean Lycke as project manager.
The company says that in research undertaken to date, the patch has demonstrated the potential for immediate pain relief in patients with aphthous stomatitis. The oral patch is designed to shield the ulcer giving instant pain relief and promoting healing primarily through a hygroscopic effect.
The biodegradable patch is placed directly over the aphthous ulcer and stays in place for three to four hours, before converting into a gel that can either be swallowed or spit out.
"We are pleased to soon be ready to welcome our first patient to the trial," said Jean Lycke.
The clinical trial will run for an estimated six to nine months, with future production of the product to take place in Sweden.
The study will be conducted in collaboration with private dental clinic chain Oral Care AB while production of the patch will be managed by Aurena Laboratories, a strategic partner of Mucocort.
Lycke continued: "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. The collaboration with Umeå Biotech Incubator (UBI) has also been a significant part of our success in developing our patch.”
According to GlobalData’s medical device pipeline database, 20 buccal delivery devices are in various stages of development globally.
Buccal delivery devices are used to administer drugs within or through buccal mucosa to affect local or systemic pharmacological actions.
