FDA OKs tamper resistant form of OxyContin

The U.S. Food and Drug Administration said on Monday it has approved a new formulation of controlled-release OxyContin that makes the powerful pain drug harder to abuse.

OxyContin, made by privately held Purdue Pharma, is a favorite of drug abusers because it contains large quantities of the potent opioid pain killer oxycodone.

The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication, thereby potentially decreasing the risk of overdose due to tampering.

The new formulation will likely result in less abuse by snorting or injection, but it still can be abused or misused by ingesting larger doses than are recommended, the FDA said. (For more, see today’s Reuters Health story, “Prescription drug overdoses on the rise in U.S.”)

OxyContin is designed to slowly release oxycodone for patients who need a continuous, around-the-clock treatment for moderate to severe pain for an extended period of time.

With the previous formulation those intent on abusing the drug could release high levels of oxycodone all at once by tampering with the pills.

“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,” Bob Rappaport, the FDA’s director of the division of anesthesia and analgesia products, said in a statement.

“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,” Rappaport said.

About half a million people took OxyContin non-medically for the first time in 2008, according to the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.

Stamford, Connecticut-based Purdue Pharma will be required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of its drug, the FDA said.

—-
NEW YORK (Reuters)