From Medscape Medical News
Yael Waknine
August 6, 2009 — The US Food and Drug Administration (FDA) has approved a hydrocortisone plus acyclovir cream (Lipsovir, Medivir AB) 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. Treatment is approved for adults and children aged 12 years and older.
The approval was based on data from a clinical phase 3 program showing that 42% of patients using hydrocortisone/acyclovir cream did not develop cold sores with blisters, ulcers, and crusting compared with 26% of those receiving placebo.
For those patients who developed cold sores, healing time was significantly decreased, being lowered by 1.5 days in the active treatment group vs in the placebo group.
"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," the company noted in a news release.
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