Abuse-Deterrent Labeling Approved for Reformulated OxyContin
The FDA has approved updated labeling for reformulated OxyContin (oxycodone hydrochloride controlled-release, Purdue) tablets, effectively putting a nail in the coffin for potential generic opioid formulations that do not have abuse-deterrent properties.
The new labeling states that reformulated OxyContin is imbued with “physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting),” according to a press release from the FDA announcing the approval.
The FDA further announced that the reformulated OxyContin is therapeutically equivalent to original OxyContin, which ceased delivery to pharmacies in August 2010 due to safety concerns (the abuse-deterrent version of the agent was introduced in April 2010). The agency added that given that the original version’s higher risk for some forms of abuse and misuse “the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.” Thus, the FDA stated at the time of the new approved labeling it would not consider for approval new drug applications for generic agents based on the approval of the original, discontinued version of OxyContin.
The new labeling states that reformulated OxyContin is imbued with “physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting),” according to a press release from the FDA announcing the approval.
The FDA further announced that the reformulated OxyContin is therapeutically equivalent to original OxyContin, which ceased delivery to pharmacies in August 2010 due to safety concerns (the abuse-deterrent version of the agent was introduced in April 2010). The agency added that given that the original version’s higher risk for some forms of abuse and misuse “the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.” Thus, the FDA stated at the time of the new approved labeling it would not consider for approval new drug applications for generic agents based on the approval of the original, discontinued version of OxyContin.
OxyContin was approved by FDA in its original form in 1995. The original formulation went off patent on April 16.
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