The US Food and Drug Administration (FDA) has refused to approve any generics of the original non-crush-resistant formulation of oxycodone. The originator drug Oxycontin is manufactured by Purdue Pharma (Purdue) and the US patent on the blockbuster painkiller expired in April 2013 [1].

OxyContin is formulated to release oxycodone over a long period of time. However, when crushed or chewed and either inhaled by the nose, injected or swallowed, the oxycodone is released and absorbed rapidly producing a heroin-like effect euphoria. It is for this reason that Purdue reformulated the product back in 2010 to produce a crush-resistant version of the drug. This abuse-resistant version of Oxycontin has patent protection in the US until 2025 [1].

The approval of the generic from India-based generics maker Ranbaxy Laboratories came despite the fact that the US has been pressing Canada to ban generics of the original non-crush-resistant formulation of oxycodone, citing studies that show the more addictive formulations are migrating south of the border.

Mr Gil Kerlikowske, Director of the White House Office of Drug Control Policy, had written to Canada’s Health Minister Rona Ambrose on 8 November 2013 stating that ‘more can be done to prevent the misuse and diversion of generic oxycodone products, which remain available in Canadian markets in crushable forms’.

Health Canada has defended its approval of the drug, stating that the agency ‘rigorously’ assesses every drug’s safety and efficacy before approving it. While Health Canada spokeswoman Mrs Leslie Meerburg added that the agency ‘is working to help companies develop tamper-resistant opioid formulations that might help reduce the risk of abuse’.

Related article

Actavis makes agreement for generic abuse-deterrent oxycodone

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. FDA is dragging its feet over oxycodone generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from: www.gabionline.net/Generics/General/FDA-is-dragging-its-feet-over-oxycodone-generics

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.