Pharmacy Daily | FDA blocks generic OxyContin

THE US Food and Drug Administration has formally blocked generic pharmaceutical makers from producing versions of the old form of OxyContin, in the light of the patent on the original drug which is set to expire next week. Purdue Pharma, which originally patented the drug in 1995, created a “crush-resistant” formulation in 2010 in order to combat widespread abuse of the painkiller. The FDA said the original OxyContin was often manipulated to defeat its extended-release properties which significantly increased the risk of serious adverse events, including overdose and death. The newer formulation cannot be injected if someone tries to dissolve the tablets in liquid, and Purdue stopped shipping the original OxyContin to US pharmacies in August 2010. In a statement issued overnight, the FDA said it had approved “abuse-deterrent labelling” for Purdue’s reformulated OxyContin, which indicates that the products has physical and chemical properties that are “expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting)”. The agency also said it would not accept or approve any generic drug applications which rely on the approval of the original OxyContin. That means that generic makers will have to create their own crushresistant formulations, delaying the entry of generic versions. “The development of abusedeterrent opioid analgesics is a public health priority for the FDA,” said a spokesperson. Postmarketing assessments of the impact of reformulated OxyContin on abuse are ongoing, the FDA said.

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