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news.Sweden-based pharmaceutical company Medivir has submitted a marketing authorization application to the European regulatory authorities for Lipsovir, a topical product for prevention and treatment of cold sores.
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Lipsovir is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) in a proprietary cream base developed by Medivir.
The clinical Phase III program demonstrated that the development of cold sores can be prevented with early treatment initiation, an effect that currently available products for this indication lack. Lipsovir thereby provides individuals prone to recurrent cold sores with a clinically important benefit compared to currently available products, the company said.
Borje Darpo, head of Medivir’s clinical development department, said: “We have achieved a substantial and important milestone for Lipsovir in filing registration applications in both the US and Europe.”