Acyclovir Lauriad^®: a muco-adhesive buccal tablet for the treatment of recurrent herpes labialis

Abstract

The treatment of recurrent herpes labialis remains a challenge in the 21st century. The virus is ubiquitous and there is no vaccine against the disease. Although recurrence episodes are usually of shorter duration than the primary episode, they are debilitating to patients and there is significant stigma associated with the disease. Acyclovir Lauriad^® is a new topical agent that was approved by the US FDA in 2013 for the treatment of recurrent herpes labialis, which affects approximately 20–40% of the population worldwide. The drug is a muco-adhesive tablet, applied to the upper gum at the onset of prodromal symptoms. Utilizing Lauriad^® technology, a biologically active compound traverses the mucous membrane to deliver a high concentration of acyclovir directly to the site of the herpes simplex virus infection. Data from a Phase III clinical trial shows that this may be a promising therapy for patients with recurrent herpes labialis.

Keywords::

• acyclovir
• antiviral
• buccal
• herpes
• HSV
• lip
• mucosal
• Sitavig^®

Financial & competing interests disclosure

S Tyring participated in the BioAlliance Pharma UP BA 2005/21/02 study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Acyclovir Lauriad^® (Sitavig^®) is a new muco-adhesive tablet that was approved by the US FDA in April 2013 for recurrent herpes labialis in immunocompetent adult patients.

• The therapy is suited for patients who require episodic therapy and who can recognize prodromal symptoms of disease such as pain, tingling and pruritis.

• One tablet is used per episode and is placed in the mouth on the upper gum on the affected side just above the incisor tooth. It is held in place with a slight pressure over the upper lip for 30 s to ensure adhesion.

• In clinical trials, a single application of acyclovir muco-adhesive buccal tablet resulted in high exposure of acyclovir to saliva and oral mucosa, and levels were sustained for 24 h. This is a major advantage over oral acyclovir as it requires frequent dosing due to its low bioavailability.

• Approximately 88% of the population is herpes simplex virus type 1 seropositive by the age of 40 years and 20–40% of those patients experience episodes of recurrence.

• The therapy works by blocking viral replication to enable reduction of the symptoms of disease and shorten overall time of disease. This has been supported by data from a Phase III clinical trial.

• Compliance with treatment may improve due to its one-time dosing and ease of use.

• Further research needs to be performed to assess the long-term efficacy and safety of acyclovir Lauriad^® (Sitavig^®).