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Clinical Trials Resource Center

FDA Approved Drugs » 2000
Medical Areas: Immunology | Infections and Infectious Diseases

View By:Year | Company | Conditions | Therapeutic Areas | Drug Names

ABREVA (docosanol)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: AVANIR PHARMACEUTICALS
Approval Status: Approved July 2000
Treatment Area: oral-facial herpes simplex

General Information

Abreva is a docosanol 10% cream for the topical treatment of recurrent oral-facial herpes simplex episodes (cold sores or fever blisters). The active ingredient is n-docosanol, also known as behenyl alcohol, a saturated 22-carbon aliphatic alcohol which exhibits antiviral activity against many lipid enveloped viruses including herpes simplex virus (HSV).

It is being marketed by SmithKline Beecham and will be available without prescription in the over-the-counter market.

Clinical Results

Two clinic-initiated, double-blind, placebo-controlled multicenter trials of docosanol 10% cream were held to establish its effectiveness in treating recurrent oral-facial herpes simplex. Patients that were otherwise healthy were randomized to either docosanol 10% cream or placebo. The cream was applied at the beginning of an outbreak, before the development of a lesion, five times daily. Total healing occurred when there was no longer evidence of an active lesion.

Studies showed that the average healing time of a recurrent oral-facial herpes simplex episode in the 370 docosanol 10% cream-treated patients was approximately one day shorter than that observed in the 367 placebo treated patients. The noted difference in healing times between the two groups was statistically significant in both trials (p ~ 0.01). In addition to the positive treatment effect for the primary efficacy parameter in the trials, docosanol 10% cream also demonstrated statistically significant reductions - when compared to placebo - in the duration of the important oral-facial herpes simplex associated symptoms of pain and/or burning, itching or tingling (p < 0.03).

A subgroup in the trial noted that docosanol stopped cold sore episodes from progressing to the blister stage in 34% of patients who applied it at the early sign of an outbreak (redness) compared to 23% in the equivalent placebo group.

Side Effects

Headache was the most common side effect, but it occurred with the same frequency in patients treated with placebo as with docosanol.

Mechanism of Action

Docosanol works by inhibiting fusion between the human cell plasma membrane and the herpes simplex virus (HSV) envelope, thereby preventing viral entry into cells and subsequent viral replication. Since the compound doesn't act directly on the virus, it is unlikely it will produce drug resistant mutants of HSV. All known competitive Rx products work by inhibition of viral DNA replication and, as such, carry risk of mutating the virus. (From Company Site)

Additional Information

Cold sore episodes can be caused by stress, fever, fatigue and exposure to sunlight. Sufferers have reported that they avoid family and friends during outbreaks, which usually last about a week, but can last as long as two weeks. Up to 15 percent of sufferers have reported staying home from work during an outbreak. Due in part to the fact that there have been few effective treatments, only a small percentage of patients seek professional care.

80% of adults in the United States are carriers of the virus that causes cold sores. Every year, 20 to 40 percent of these - more than 50 million adults - develop symptomatic episodes. The number of treatable episodes ranges from 100 to 130 million outbreaks annually, with 70 to 80% of these episodes treated by products in the over-the-counter (OTC) market.