Scientists from the University of Sheffield School of Clinical Dentistry, working with Dermtreat A/S of Copenhagen, have developed a patch that administers steroids directly to oral ulcers or lesions while creating a protective barrier around the affected area, accelerating the healing process.
The patch uses special polymers that can stick to moist surfaces. The researchers call it a breakthrough therapy for treating mucosal conditions such as oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS), which cause painful lesions and affect 1% to 2% of the population.
Ulcers and lesions inside the mouth typically are treated with creams or mouthwashes, which affect the whole mouth, not just the target area, making them less effective. The Rivelin patch, though, promises a long adhesion time and high flexibility that conforms with the surface of the insider of the mouth.
“Chronic inflammatory conditions such as OLP and RAS, which cause erosive and painful oral lesions, have a considerable impact on quality of life,” said Craig Murdoch, PhD, lead author and reader in oral bioscience at the dental school.
“Current treatments consist of using steroids in the form of mouthwashes, creams, or ointments, but these are often ineffective due to inadequate drug contact times with the lesion,” said Murdoch.
“The patch acts like a plaster inside your mouth, which means it is very effective at directly targeting the specific area as well as forming a protective barrier,” Murdoch said. “Patients who have trialed the patch found it to be very comfortable to wear, and they were really pleased with the length of adhesion, which makes it particularly effective and efficient.”
“Collaboration with the University of Sheffield has undoubtedly accelerated the translation of our intellectual property towards clinical use. Our company are very confident that we will soon gain regulatory approval for the first adhesive drug delivery technology to address pressing clinical needs in oral medicine,” said Jens Hansen, CEO at Dermtreat A/S.
“We look forward to continuing this collaboration, which will be increasingly directed at finding new clinical applications for muco-adhesive patches,” Hansen said.
Dermtreat A/S recently received $17.7 million from venture capital firm Sofinnova. The funding will take the patches into phase two clinical trials, which will run at several sites in the United States and the United Kingdom. Also, Dermtreat A/S is funding further research at the dental school to develop the next generation of patches for administering other useful drugs.
The study, “Pre-Clinical Evaluation of Novel Mucoadhesive Bilayer Patches for Local Delivery of Clobetasol-17-Propionate to the Oral Mucosa,” was published in Biomaterials.
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