The US Food and Drug Administration has given marketing authorisation to BioAlliance Pharma’s new treatment for orolabial herpes, called Sitavig.
The treatment is a small mucoadhesive tablet which the patient places on the gum, where it then delivers a high concentration of antiviral drug acyclovir directly to the lip and the site of the cold sore infection.
Sitavig was given marketing permission after a phase III international study conducted on 775 patients. During the study the treatment demonstrated a high level of efficacy in terms of healing time with one single tablet containing 50mg of acyclovir and an excellent tolerance profile.
"We are very pleased with the outcome of this development which will allow patients, once the product is on the market, to have a drug that meets their needs," said Professor Stephen Keith Tyring of the Dermatology Department at the University of Texas Health Sciences Center in Houston, US.
French BioAlliance, a company that focuses on speciality and orphan products, hopes Sitavig will generate significant income for the company. It will now accelerate discussions with its international partners to market the drug across the US.
"Drug approval in the United States represents for all laboratories, whether large or small, both a challenge and a major success once it has been obtained since the process is so complex and significant levels of competence and expertise are required," said Judith Greciet, CEO of BioAlliance Pharma.
"This is a key step in creating company value for our shareholders and should allow us to generate revenue thereby fully participating in the growth and success of BioAlliance," she added.
Orolabial herpes is an extremely common condition. According to BioAlliance some 40 million people in the US suffer more than 100 million episodes of Herpes Labialis annually.
Sitavig is the second treatment BioAlliance has marketing approval for; it also has approval for Loramyc/Oravig, for the treatment of Oropharyngeal candidiasis or thrush, in the US and Europe, plus 26 other countries.