Health Canada to review Sitavig for recurrent herpes labialis

Cipher Pharmaceuticals announced in a press release that Health Canada has accepted to review its new drug submission for Sitavig for treating recurrent herpes labialis in adults.

Sitavig (acyclovir mucoadhesive buccal tablets) is available in the United States as a single-dose prescription cold sore treatment, and is based on proprietary Lauriad technology from Onxeo S.A., according to the release.

Patients place the 50 mg mucoadhesive tablet inside the lip and the upper gum, which has been shown in clinical trials to deliver acyclovir to the herpes labialis infection site, the release reported.

“Cold sores are one of the most common viral skin infections, affecting one in five Canadians,” Shawn O’Brien, president and CEO of Cipher, stated in the release. “In additional to the pain, this is a highly stigmatizing disorder. If approved, Sitavig will represent an attractive treatment option for the many Canadians who suffer from cold sores and another key addition to our growing Canadian dermatology portfolio.”

“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,” Judith Greciet, CEO of Onxeo S.A., stated in the release.

The North American distribution rights to Sitavig were acquired by Cipher in April 2015 with the acquisition of Innocutis Holdings LLC, which originally licensed the product from Onxeo S.A., according to the release.

Reference: www.cipherpharma.com