Magazine article Drug Topics

FDA Approves Acyclovir Buccal Tablets for Recurrent Herpes Labialis

Magazine article Drug Topics

FDA Approves Acyclovir Buccal Tablets for Recurrent Herpes Labialis

Article excerpt


In April 2013, the Food and Drug Administration approved acyclovir (Sitavig, BioAlliance Pharma) mucoadhesive buccal tablets (MBT) for the treatment of recurrent herpes labialis in immunocompetent adults. Acyclovir is a synthetic purine nucleoside that is converted into a triphosphate form through enzymatic reactions. Acyclovir triphosphate inhibits replication of herpes viral DNA through insertion into the viral DNA chain and subsequent termination. Each tablet contains 50 mg of acyclovir. Acyclovir MBT is contraindicated in patients with hypersensitivity to acyclovir, milk protein concentrate, or any other components of the product.


In a randomized, double-blind, placebo-controlled trial, 378 patients were treated with acyclovir MBT and 397 were treated with placebo. A single dose of acyclovir MBT 50 mg was given to patients with recurrent herpes labialis, of which the majority (68.4%) had five or more episodes in the previous year. Patients' average age was 41 years of age; most were Caucasian (94.9%) and female (68.6%). Patients were instructed to apply acyclovir MBT within one hour of appearance of prodromal symptoms, with the same instructions as for the approved dosing.

Duration of the herpes labialis episode for patients in the acyclovir MBT group was approximately one-half day less than that for patients taking placebo. Additional outcomes showed that patients randomized to acyclovir MBT experienced less time from prodromal symptoms to healing, more patients had abortive episodes that did not progress to vesicular lesions, and duration of abortive episodes was briefer. For patients who agreed to follow up at nine months, the time to recurrence of a herpes labialis episode was significantly delayed - by 37 days - for those treated with acyclovir MBT, compared to recurrence time for those treated with placebo.


The same randomized trial evaluated patients for safety outcomes. Treatment of emergent adverse events occurring in 1% or more of the patients included headache (1% acyclovir MBT and 2% placebo) and application site pain (1% in both groups). No one discontinued drug therapy due to adverse events. In each group, one report of headache was classified as severe. …

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