Reformulated OxyContin To Receive Abuse-Deterrent Labelling

Date: Apr-17-2013A new reformulated form of Oxycontin (a highly addictive oxycodone hydrochloride) has received a unique labeling update by the U.S. Food and Drug Administration regarding its abuse potential.

People most commonly abuse Oxycontin by injecting or snorting it. However, with Purdue Pharma L.P.'s new reformulated version, abuse is much harder.

OxyContin abuse is a huge problem in the U.S. In 2011 only 7% of OxyContin users got their drug from their doctor while 13% bought it from a drug dealer.  In Florida oxycodone was one of the most abused pills - its drug abuse problem in the state was out of control.

The reformulated form of Oxycontin provides the same therapeutic benefits as the original drug but with a reduced risk of abuse. The FDA has said that the reason why the original Oxycontin was removed from the market was because its benefits no longer outweighed its risks.

Similarly the FDA has prohibited all abbreviated new drug applications, or generics, that rely on the approval of the original OxyContin.

The original formulation of OxyContin was approved by the FDA in 1995. Sadly, the number of people who abused the drug became extremely high and manipulation of its extended-release properties was a serious problem. The new reformulated version of Oxycontin was approved in April 2010, making manipulation of the drug much harder.

According to Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research:

"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA. While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin."

The new form of OxyContin is now much more difficult to crush or dissolve and can't easily be prepared for injection. However there is still potential for abuse orally.

The original OxyContin was commonly crushed and snorted recreationally

If the agency finds any abuse deterrent properties in the new formulation they can also make generic makers add these abuse-deterrent properties as well.

The agency analyzed the following as part of their review of the issue:

Information about the withdrawal of the original OxyContin
Peer-reviewed literature and clinical data
Citizen petitions inquiring why the original OxyContin was withdrawn from sale

The impact the reformulated OxyContin will have on reducing abuse is still being assessed and the FDA will report more detailed information in the near future.

There is growing concern that the change in the formula of the widely abused prescription painkiller OxyContin has many addicts switching to heroin, a drug that is even more dangerous.

Written by Joseph Nordqvist

View drug information on OxyContin.

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