FDA approves a more tamper-resistant formulation of OxyContin

FDA granted marketing approval for a new formulation of controlled-release oxycodone (OxyContin, Purdue Pharma) on April 5, 2010.

Key Points

FDA granted marketing approval for a new formulation of controlled-release oxycodone (OxyContin, Purdue Pharma) on April 5, 2010. The reformulated drug is designed to help discourage misuse and abuse of the medication by preventing people from overcoming the sustained-release mechanism. For example, any attempt to dissolve the new formulation in liquid will result in a "gummy substance" that would be difficult, if not impossible, to be drawn up into a syringe and injected.

The drug is formulated to slowly release large quantities of oxycodone over an extended period of time. It is commonly used to treat patients who require continuous, around-the-clock management of sustained or chronic moderate-to-severe pain, such as patients with cancer. Unfortunately, many people were able to release most, if not all of the oxycodone from the older formulation at once. This rapid release of the potent opioid often resulted in fatal overdose and contributed to high abuse rates. In fact, a recent report from the U.S. Substance Abuse and Mental Health Services Administration estimated that approximately 500,000 people tried OxyContin for non-medical purposes in 2008.

"OxyContin now joins Embeda as opioids with tamper-resistant dosage forms," noted Richard Gannon, PharmD, a clinical pharmacist and pain management specialist for the Department of Pharmacy at Hartford Hospital in Hartford, Conn. He continued, "These new products should prevent abuse by crushing, chewing, or dissolving and injecting."

"It will be interesting to see if the post-marketing surveillance data supports their tamper-resistant contention," said Dr Gannon. "These drugs may still be abused by swallowing the tablets whole."

Bob Rappaport, MD, director of the Division of Anesthesia and Analgesia Products in FDA's Center for Drug Evaluation and Research said in an FDA press release, "Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction."

According to Dr Gannon, the best deterrent to abuse is a practitioner that appropriately evaluates a patient's pain problem and screens the patient for a history of substance abuse. Dr Gannon further emphasized, "Use of an opioid contract, urine drug screens, pill counts, and so on can be effective components of a comprehensive pain management program."

SOURCES

1. FDA. FDA Approves New Formulation for OxyContin. April 5, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207480.htm. Accessed April 6, 2010.

2. Substance Abuse and Mental Health Services Administration. 2009. Results from the 2008 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-36, HHS Publication No. SMA 09-4434) Rockville, MD. September 1, 2009. Available at: http://ncadistore.samhsa.gov/catalog/productDetails.aspx?ProductID=18177/. Accessed April 23, 2010.