Orexo announces successful completion of OX219 initial pharmacokinetic trial for opioid dependence

“The successful outcome of this trial shows important progress for Orexo in building its proprietary pipeline and further confirms the quality of our drug reformulation capabilities. This is the first of many important steps towards our defined goal of becoming a leading specialty pharmaceutical company”

Orexo AB (STO:ORX) announces successful completion of the initial pharmacokinetic trial in the OX219 project. In the comparative bioavailability study, the OX219 buprenorphine/naloxone sublingual tablet formulation demonstrated favourable profiles compared to the comparator Suboxone®, which is the market leading product for treatment of opioid dependence. Global value of the opioid dependence market today is approximately US$ 1.4 billion. Based on the positive results, Orexo will be meeting with the FDA during Q1-2011 to discuss the development program for OX219. Following the meeting with the FDA Orexo will make a final decision on the development of OX219.

"The successful outcome of this trial shows important progress for Orexo in building its proprietary pipeline and further confirms the quality of our drug reformulation capabilities. This is the first of many important steps towards our defined goal of becoming a leading specialty pharmaceutical company" says Dr Torbjörn Bjerke, President and Chief Executive Officer of Orexo."

OX219 is a novel sublingual tablet formulation of buprenorphine and naloxone for the treatment of opioid dependence within a framework of medical, social and psychological treatment. Buprenorphine is a long acting partial μ-opioid receptor agonist which relieves cravings for opioids of abuse. Naloxone is an opioid antagonist which is included to deter intravenous abuse. When taken sublingually as intended, naloxone is almost completely eliminated by first pass metabolism, but if injected it prevents getting a "high" and produces uncomfortable withdrawal symptoms in opioid dependent users.

SOURCE Orexo