FDA Approves Medivir Pharma's Lipsovir

Lipsovir is a cream containing a combination of acyclovir and hydrocortisone.

Acyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Acyclovir will not cure herpes, but it can lessen the symptoms of the infection.

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Lipsovir is used for the early treatment of cold sores to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time.

Lipsovir is a topical cream used in the treatment of cold sores. It is a combination medication containing hydrocortisone, an anti-inflammatory agent, and acyclovir, an antiviral agent.

Cold sores are caused by a viral infection known as herpes. They appear when the body's immune system produces a defensive response against the virus. There are two different types of herpes viruses including herpes simplex virus one (HSV-1) and herpes simplex virus two (HSV-2). Cold sores can be caused by either version of the virus; however, most are caused by HSV-1.

Lipsovir helps treat cold sores both by fighting actions of the immune system as well as the herpes virus that triggers them.

The US Food and Drug Administration (FDA) has now approved Lipsovir, i.e. granted Medivir's New Drug Application (NDA) 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.

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. This gives Medivir a clear competitive edge on the US market, which is the most important, and economically speaking the greatest single, market.

Medivir has received approval to market Lipsovir (hydrocortisone and acyclovir, cream) for the topical treatment of cold sores in patients ≥12 years of age. Lipsovir is indicated for early treatment of recurrent herpes labialis (cold sores) to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented.