A Phase III trial of the buccal tablet, called Lauriad (miconazole), showed that the product was at least as effective as an oral gel formulation of the antifungal in the treatment of oropharyngeal candidiasis, also known as thrush.
Lauriad was also administered with a more convenient schedule than the miconazole oral gel comparator - once-daily rather than four times a day - suggesting that it could improve compliance with therapy
This is significant, because while current treatment guidelines recommend the use of topical or localised therapies such as gel, lozenges and mouthwashes for oropharyngeal candidiasis, they have been generally unsuccessful in treating this infection.
Patients have resisted the multiple daily applications and unpleasant taste, while transient drug concentrations in the oral cavity have limited efficacy. And this has resulted in the preferential use of systemic antifungal agents, which carry a greater risk of side effects and the generation of resistant fungal strains.
The study enrolled 306 patients who had received radiotherapy for head and neck cancer, a treatment which results in changes in the lining of the mouth and a reduction in saliva production that makes oral thrush more likely to occur.
Dominique Costantini, BioAlliance's CEO, said: "Our goal is to provide physicians with an effective option for local treatment of this fungal infection that obviates the need to prescribe systemic antifungals."
Lauriad is placed beneath the upper lip and adheres to the mouth lining while it releases the antifungal agent. It is made up of a natural polymer that gradually absorbs water, triggering sustained release of miconazole as the tablet erodes. Once the tablet is in place, patients can eat, drink and carry on normal daily activities while the tablet dissolves.
BioAlliance is also developing its buccal tablet technology to deliver drugs for other applications, including acyclovir for oral herpes and the opioid analgesic fentanyl for severe pain.