The Swedish company Laccure AB recently got CE marking as a Class IIa medical device product for its treatment and prevention of bacterial vaginosis (BV) with a proven cure rate of 80 percent already after one vaginal tablet. Addressing the unmet needs of up to 300 million women suffering from BV infection, the new treatment represents a considerable commercial potential in the OTC market.
Laccure's novel, non-prescription vaginal tablet has been tested in randomized controlled clinical multicenter studies including 126 women. The results show a cure rate of 80 percent following a single administration of one vaginal tablet. Along with a good safety profile and by fully meeting women's need for user-friendly comfort, this represents a major improvement in the treatment of BV. Moreover, the use of this new treatment might significantly reduce the need for antibiotics and consequently limit the risk of antibiotic resistance.
The product is based on a proprietary substance that releases lactic acid over an extended period of time to decrease elevated vaginal pH.
"Showing such high cure rates already a week after single administration exceeded our ambitious expectations for this product. The study results have been confirmed in two independent studies which led to the successful CE marking, says Dr. Jeanette Robertsson, CEO of Laccure AB.
"As there is a lack of effective and user-friendly treatment that is also effective in preventing recurrent episodes of bacterial vaginosis, this product will truly fill an unmet need in the market. Product launch in early 2013 is entirely possible if we can find the right marketing partner," says Dr. Lennart Bruce, Board Member of Laccure AB.