• 10/30/2006
  • web resource, no city listed
  • Yael Waknine
  • Medscape.com

On October 13, the French regulatory authority Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSAPS) approved miconazole Lauriad 50-mg bioadhesive buccal tablets (Loramyc, made by BioAlliance Pharma SA) for the treatment of oropharyngeal candidiasis in immunodepressed patients, particularly those with head and neck cancers who have undergone radiotherapy and those infected with HIV.

Miconazole Lauriad is designed with proprietary technology (Lauriad) that ensures an early and extended release of the active component at the site of infection, maintaining therapeutic levels of the drug (saliva concentration > 1 µg/mL) while reducing the risk for drug interactions and systemic effects. In contrast with other topical treatments such as gels, rinses, or lozenges that require multiple daily dosing, the product is applied once daily on the upper gum.

According to a company news release, approval of miconazole Lauriad was based on data from 2 European phase 3 clinical trials. The first of these was conducted in 25 HIV-positive patients at 11 clinical sites in France. Results showed clear evidence of efficacy (success rates at day 7 and 15 were 89.5% and 94.7%, respectively) and the study was therefore terminated early.

The second study was a comparative, multicenter, randomized study in 306 French and North African patients with head and neck cancer treated by radiotherapy and presenting with candidiasis and low saliva levels (dry mouth). Results at day 14 confirmed the noninferiority of the miconazole Lauriad 50-mg tablet applied once daily compared with miconazole 125-mg oral gel applied 4 times daily.

According to the news release, miconazole Lauriad is currently being evaluated in a pivotal phase 3 US clinical trial with the objective of pursuing its approval by the Food and Drug Administration. Also, the same technology is being used to develop a second product (acyclovir Lauriad) for the treatment of oral herpes.