Orexo reports successful achievement of product stability data for OX219 – submission of the US file now advanced 5 months to September 2012
Swedish specialty pharmaceutical company Orexo today communicated that it projects a late Q3 regulatory submission to the US regulatory agency FDA of its treatment of opioid dependence, OX219. Opioid dependence is in the US increasingly being recognized as a major health problem, with over two million Americans affected and costing the society an estimated USD 25 billion in related health care cost.As communicated in July, following the pre-NDA meeting with FDA, the final product development task outstanding before OX219 could be submitted in the US, was completion of certain product
