The entire Phase III program comprised of almost 3000 patients in five studies, the pivotal trial being the largest ever conducted with 1443 patients treated out of 2437 recruited. Treatment with Lipsovir prevented the development of cold sores in 42% of patients.
Lipsovir is a patented combination of hydrocortisone and aciclovir in a proprietary cream base developed by Medivir. Lipsovir prevented cold sores significantly better than placebo (p<0.0001). Even though company's proprietary cream base seemed to have increased the effect of aciclovir, Lipsovir's preventive effect was superior (p=0.014). The healing time of ulcerative recurrences was reduced by 1.5 days in comparison to placebo, which is a clinically highly meaningful reduction. Lipsovir was well tolerated in all Phase III studies. Lars Adlersson, CEO of Medivir, said: "We have proven that the Lipsovir concept works. The combination of an antiviral and an anti-inflammatory agent in our cream base prevents cold sores. We will now continue our contacts with potential marketing partners."