Medivir trials Lipsovir® on cold sores in adolescents and the immunocompromised
Medivir’s pivotal phase III clinical trial with Lipsovir® on cold sores (labial herpes) in the North American adult population is progressing well and 60% of the patients have now been treated.
To enable the marketing of Lipsovir® to paediatric and immunodeficient patients as well, Medivir has newly commenced two smaller phase III clinical trials: one in Sweden/Russia with adolescents in the 12-17 year age group, and one in Russia/Ukraine in immunocompromised patients.
The primary aim of these studies is to show that Lipsovir® is a safe cold sore treatment in these patient populations. The trial design for both these clinical trials has been discussed with the US FDA (Food and Drug Administration).
Medivir plans on the results from the pivotal phase III trial in North America being ready for evaluation during the autumn. The two smaller trials are estimated to be ready for evaluation no later than at the end of 2007. An application for marketing authorisation will be submitted early 2008 and an approval is expected at the end of 2008, as communicated earlier.