FDA Approves New OxyContin Formulation

WASHINGTON, April 6 (UPI) — The U.S. Food and Drug Administration has approved a new formulation of the controlled-release drug OxyContin that’s designed to prevent misuse and abuse.

The FDA said the new medication slowly releases the potent opioid oxycodone to treat patients requiring a continuous, around-the-clock opioid analgesic for managing moderate to severe pain.


“Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often,” the FDA said. “However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse.”

The reformulated medication is intended to prevent the drug from being cut, broken, chewed, crushed or dissolved to present less risk of overdose due to tampering, snorting or injection.

“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,” said Dr. Bob Rappaport, director of the FDA’s Division of Anesthesia and Analgesia Products. “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.”

OxyContin is manufactured by Purdue Pharma L.P. of Stamford, Conn.

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