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According to Pharmacychoice leading web portal for pharmacy resources, news and education, the US FDA approves Lipsovir (R) for marketing and sales in US, i.e. granted Medivir's New Drug Application for the use of acyclovir
and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented. Treatment is approved for adults and children 12 years or older.
Lipsovir® is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral) intended for the topical treatment of cold sores.
Like other cold sore pharmaceuticals Lipsovir will be a prescription (Rx) product in the US. The label, that is the indication text endorsed by the FDA, states "Acyclovir and Hydrocortisone Cream is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time".
No product currently marketed for the treatment of cold sores has a corresponding label or has been shown to prevent an outbreak with early treatment.
A clinical program has demonstrated that it is possible to prevent cold sores by early treatment initiation.
"The phase III clinical program shows that Lipsovir(R) has clear advantages compared with the current standard treatment for cold sores. The results are remarkably good and it is very positive for patients with recurrent cold sores that over 40% of episodes could be prevented by Lipsovir(R)," said Assoc. Professor Borje Darpo, Medivir's Vice President for Clinical Development.
Treatment with Lipsovir(R) prevented the development of cold sores in 42% of patients. In those patients who nevertheless developed a cold sore, the healing time and severity were significantly reduced.