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FDA bars generic version of Purdue’s painkiller OxyContin

New abuse-deterrent formulation means original version no longer has positive benefit-to-risk profile

FDA bars generic version of Purdue's painkiller OxyContin

US regulators have banned generic versions of Purdue Pharma's painkiller OxyContin after the company received approval for updated labelling for a reformulated version of the drug that prevents abuse.

Since its initial approval from the FDA in 1995, the opioid-based OxyContin (oxycodone hydrochloride controlled-release) has been subject to misuse and abuse, often following manipulation to overcome its extended-release properties, increasing the risk of adverse events, including overdose and death.

This led to the launch in April 2010 of a new version of the drug that is more difficult to crush, break, or dissolve, which made abuse via injection or snorting more difficult.

The FDA has now approved updated labelling for this reformulated product from Pardue, meaning that the original version of OxyContin must be withdrawn as its benefits no longer outweigh its risks.

This also means any generic version based on the original product will not be able to reach market as it does not have the abuse-deterrent formulation.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Dr Douglas Throckmorton, deputy director for regulatory programmes in the FDA's Center for Drug Evaluation and Research.

“While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”

In its statement, Purdue said it was “gratified” by the FDA's decision, which allows the company retain exclusivity until 2025 on a drug that made more than $2.5bn in the US during 2012, according to the website

The decision to ban generic versions of OxyContin that isn't formulated to prevent abuse was also welcomed by the group Operation UNITE, which campaigns against drug abuse in the US.

"I think [the decision] saves lives. Preventing this from hitting the streets is a major victory,” said Karen Kelly, president and chief executive of the organisation, as quoted in USA Today.

17th April 2013

From: Sales, Regulatory



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