Cipher Pharmaceuticals Inc.’s New Drug Submission for Sitavig has been accepted for review by Health Canada. Sitavig (acyclovir mucoadhesive buccal tablets) is proposed for the treatment of recurrent herpes labialis in adults.

In the United States, Sitavig^® is approved as a single-dose prescription cold sore treatment. Based on proprietary Lauriad^® technology from Onxeo S.A, Sitavig is a 50mg mucoadhesive tablet, which the patient places inside the lip on the upper gum and, in clinical trials, has been seen to deliver acyclovir to the site of the cold sore infection.

"The Health Canada submission for Sitavig is a joint achievement for Cipher and Onxeo that reflects great collaboration and regulatory work by the two companies over the past several months," said Judith Greciet, CEO of Onxeo S.A.  "Should Sitavig receive approval in Canada, it will strengthen the brand in North America and increase the availability of the product for patients suffering from cold sores."

Cipher acquired the North American distribution rights to Sitavig with the April 2015 acquisition of INNOCUTIS Holdings LLC, which originally licensed the product from Onxeo S.A. Cipher plans to market Sitavig through its Canadian sales force.