Dov analgesic produces favorable safety data

According to the study data, there were no meaningful signals of carcinogenicity detected after two years of testing in two species – rats and mice. The company said it believes these results to be very positive as the outcome from these two safety studies will support regulatory submissions in the US and elsewhere.

Carcinogenicity studies are required by the FDA and are a critical part of the NDA packages submitted to the agency. Carcinogenicity studies are performed by administering maximum doses of a drug in two species (usually rats and mice) for a period of two years. This timeframe is accepted as analogous to administering the drug over a lifetime in humans.

“These carcinogenicity data underscore and reinforce the findings from our long-term safety database for bicifadine in humans,” said Dr Warren Stern, senior vice president of drug development at Dov. “The data collected to-date indicate that bicifadine is very safe and well-tolerated, properties that in combination with its previously reported efficacy should enhance our ability to build a strategic partnership to develop and commercialize the drug.”