The aim of OX219 is to create a new, patentable drug for the treatment of various forms of opioid dependence. The active substance in OX219, buprenorphine, has documented good efficacy in the treatment of opioid abuse within the framework of medical, social and psychological rehabilitation. Buprenorphine is effective against withdrawal symptoms and blocks the “high” effects of other opioids. OX219 also contains naloxone, which counteracts "high" effect that may arise following the intravenous injection of a disolved tablet. Combining buprenorphine and naloxone in a single tablet reduces the risk of intravenous abuse and illegal dealing.
Project status
An initial pharmacokinetic study was carried out during 2010. The study showed good results compared with the competing preparation Suboxone®, which is the current market leader for the treatment of opioid dependence. Successful discussions with the US FDA about the clinical development program took place in a pre-IND meeting held during February 2011.
Market
Use of Suboxone has grown over the past few years and the product is now selling for around 1.2 billion per year (IMS 2010), with the bulk of sales in the US.