The US Food and Drug Administration has approved a new formulation of controlled-release oxycodone (OxyContin), designed to discourage misuse and abuse of the medication, which is prescribed by doctors for the management of moderate to severe pain when a continuous, around-the-clock analgesic is required for an extended period of time.
Yael Waknine of Medscape Today writes that controlled-release oxycodone tablets contain a large quantity of the drug, allowing extension of the dosing interval. Individuals seeking to abuse oxycodone have been able to release high levels of the opioid medication from the previously approved formulation, potentially resulting in overdose.
According to the US Substance Abuse and Mental Health Services Administration's National Survey on Drug Use and Health, approximately 500,000 people abused oxycodone for the first time in 2008.
"The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication," FDA officials noted in a news release. "The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended."
"It is Purdue's position that we will not speculate on the impact that the formulation will have on misuse and abuse. This formulation is not tamper resistant and can still be abused,” said Libby Holman, a representative from Purdue Pharmaceuticals, to Medscape Pharmacists.
According to a company news release: "Purdue elected to reformulate OxyContin to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction."
"There is actually no discrepancy at all [between the FDA's and Purdue's statements]. We completely agree with Purdue's statement," Karen Riley, MPH, medical products team leader in the FDA Office of Public Affairs, toldMedscape Pharmacists, while noting that data indicate a potential for reducing the risk of overdose caused by tampering and the risk for abuse from snorting or injection.
In an FDA news release, Bob Rappaport, MD, said, "Although this new formulation of [oxycodone] may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction."
Dr. Rappaport is the director of the Division of Anesthesia and Analgesia Products in the FDA's Center for Drug Evaluation and Research.
"As with all opioids, safety is an important consideration," Dr. Rappaport added. "Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."
As a condition of approval, the manufacturer is required to conduct a post-marketing study to evaluate the potential benefits of the new formulation with respect to abuse and misuse of oxycodone. In addition, a risk evaluation and mitigation strategy is being implemented that will include the issuance of a medication guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics for pain.
In 2007, Purdue pled guilty to a felony count of misbranding oxycodone extended-release tablets with the intent to defraud and mislead, with respect to the formulation being less likely to cause abuse, addiction, tolerance, and withdrawal.