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