GYNOFLOR™, a product licensed to Acerus in Canada by Medinova AG, is an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, for the treatment of atrophic vaginitis, certain vaginal infections and/or to restore a healthy vaginal environment.
GYNOFLOR™ is approved in 39 countries across Europe, Asia-Pacific, the Middle East, Africa and South America. It was first approved in Germany in 1982 and it is estimated that up to 28 million women worldwide have been treated with the product to date. In addition, a total of 4,655 women have been studied as part of its extensive clinical trial program.
Currently, there are no approved products in Canada containing estriol, or the unique combination of estrogen and lactobacillus. Acerus plans to submit a New Drug Submission to Health Canada.