BioAlliance Pharma SA has announced submission of its Sitavir® (acyclovir Lauriad™) European registration dossier to the European Medicines Agency for the treatment of recurrent orofacial herpes in immunocompetent patients presenting more than 4 episodes a year. Sitavir® is a mucoadhesive buccal tablet delivering very high concentrations of the active ingredient in mucosa and lips.

The European registration dossier is based on the results of the a phase III clinical trial conducted in 775 patients, which found that one single application of Sitavir® 50mg reduced the occurrence of vesicular lesions (p=0.043), the duration of the herpes episode (p=0.0038) and the severity of symptoms (p=0.008). Moreover, a 9-month follow-up showed that Sitavir® had an effect on the long term, delaying the time to occurrence of the following herpes episode (p=0.04).