Drug Name (Brand / Generic)
Sitavig / acyclovir
Synthetic purine nucleoside analogue
Approved in the US
Sitavig (acyclovir) is a muco-adhesive buccal tablet indicated for the treatment of recurring herpes labialis. The drug is manufactured and marketed by BioAlliance Pharma (BioAlliance).
BioAlliance received marketing authorisation for Sitavig from the US Food and Drug Administration (FDA) for the treatment of recurring herpes labialis in April 2013.
Sitavig obtained marketing authorisation approvals in eight European countries in December 2012.
It is currently awaiting marketing authorisation approval in the rest of the EU countries.
Herpes labialis infection details
Herpes labialis is an infection of the lips, mouth, or gums. It causes blisters or sores around the mouth, which are also called cold sores or fever blisters. The condition is caused by the herpes simplex virus (HSV-1). An estimated 40 million people in the US experience more than 100 million episodes of herpes labialis in a year.
Sitavig (acyclovir) mechanism of action
Sitavig contians a synthetic purine nucleoside analogue called acyclovir. The drug works actively against herpes viruses by delivering a high concentration of acyclovir when applied on the site of the cold sore infection.
The acyclovir contained in the drug stops the replication of herpes viral DNA.
The drug is available as muco-adhesive buccal tablet in 50mg dose for mucosal administration. It is formulated on Lauriad muco-adhesive technology developed by BioAlliance Pharma.
Clinical trials on BioAlliance’s Sitavig (acyclovir)
BioAlliance Pharma conducted a Phase III clinical trial on Sitavig between May 2007 and August 2009. It was a multicentre, randomised, double blind, single dose and parallel assignment. The study enrolled 1,757 Herpes Labialis patients.
The primary outcome measure of the study was abortion of primary lesions on day 14. The secondary outcome measures included TTH of non-primary lesions, duration of episode, time to cessation of symptoms and time to recurrence of non-aborted lesions during a nine-month follow-up study.
The marketing approval for Sitavig by the US FDA was based a Phase III clinical study. The multicentre, randomised, double blind and placebo controlled study enrolled 771 patients with herpes labialis. The patients were treated with Sitavig 50mg as single dose, or placebo.
The results of the study demonstrated that the patients who were treated with Sitavig showed half a day shorter mean and median durations of recurrent herpes labialis episodes, when compared to the patients treated with placebo. The median duration in Sitavig group was 5.03 days compared to 5.95 days in placebo group.
The patients in the Sitavig group experienced a reduction of overall duration of the infection episode to 5.57 days, compared to 6.38 days in placebo group. The duration of symptoms and symptom intensity was also reduced in the Sitavig group.
The patients with non-primary vesicular lesions also experienced a reduction when treated with Sitavig. The patient satisfaction was higher in the Sitavig group compared to the placebo group.
The adverse events reported during the clinical study of Sitavig included headaches and pain at the application site.
Marketing commentary for BioAlliance Pharma’s drug
BioAlliance Pharma is leading pharmaceutical company based in Paris, France. The company is focused on developing specialty and orphan products. It develops inventive medicines for hospital use and for rare or orphan diseases. It has the necessary expertise to identify, design, develop and register drugs in both Europe and the US.
BioAlliance Pharma is yet to find potential partners for marketing Sitavig in the US market.
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