Orexo announced submission of a New Drug Application (NDA) to the FDA for Zubsolv (OX219) for treatment of opioid dependence.
A total of four clinical studies were completed in support of the filing.
Zubsolv (OX219) is a novel sublingual formulation of buprenorphine and naloxone. Zubsolv is intended for maintenance treatment of people suffering from opioid dependence. Through application of its proprietary technologies Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved taste resulting in a preference of Zubsolv in comparison with Suboxone tablet.
For more information visit www.orexo.com.