22 Nov 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Mundipharma has entered a license agreement with Japan-based Shionogi for the exclusive rights to develop, manufacture and commercialize the abuse deterrent formulation of Oxycodone, OxyContin Neo tablets (tamper-resistant OxyContin tablets), as well as Targin tablets (oxycodone-with-naloxone controlled-release tablets) in Japan. Shionogi has been providing opioids for medical use in Japan for many years including OxyContin Tablets, OxiNorm Powder and OxiFast Injection.
OxyContin Neo tablets are abuse deterrent tablets, which have been commercialized in the US since August 2010. In April, 2013, the US FDA approved the abuse-resistant characteristics of the product and announced that it would not approve any generic versions of OxyContin tablets without tamper resistance properties.
Targin tablets are abuse deterrent extended-release combination tablets of oxycodone hydrochloride and naloxone hydrochloride, combining opioid pain treatment with alleviation of constipation, an opioid induced adverse effects symptom. Targin tablets, which are approved in Europe to manage pain and reduce the symptoms of opiate-induced constipation, have been commercialized by Mundipharma in most European countries since 2009. Targin has also recently been submitted to the FDA for approval,
"We are excited to expand our partnership with Shionogi to bring improved pain management with abuse deterrence technology to Japan, which is the latest advancement in the treatment of moderate to severe pain," said Mr Raman Singh, regional MD of Mundipharma Asia, Latin America, Middle East and Africa.
"It has always been Mundipharma's aim to deliver the best outcomes for patients suffering from chronic pain. We believe this will benefit both patients and the Japanese health care system and continue to help patients manage their pain and maintain a better quality of life," he added.