Orexo files Zubsolv at FDA for treatment of Opioid Dependence - 15-Sep-2012

Orexo files at FDA for Zubsolv (buprenorphine and naloxone) for the treatment of Opioid Dependence. The earlier submission is expected to be of major commercial importance, as it provides a potential launch of Zubsolv in the third quarter of 2013 – ahead of other branded competitors. In clinical studies Zubsolv has demonstrated an accelerated dissolve time, has a smaller tablet size and an improved taste, resulting in a strong preference in comparison with the Suboxone tablet. Orexo market insights indicate that these properties, which are important product characteristics for particularly sublingual therapies, will be important drivers for the market uptake of the product.