Generic OxyContin Banned In Favor Of New Abuse-Resistant Version
Federal health regulators have banned the creation of generic OxyContin, indicating that the only approved formations of the powerful pain killers will involve pills that use abuse-deterrents introduced in 2010.
In a news release issued on April 16, the FDA indicated that it will not approve any generic equivalents based on the the original formulation of OxyContin, which was prone to abuse where the pills may be crushed and snorted or injected. The patent for the original OxyContin drug, held by Purdue Pharma L.P., expired yesterday.
Purdue obtained approval for a new abuse-deterrent version of OxyContin in April 2010, and the drug maker stopped making the original version four months later. The new version of the pill has physical and chemical properties that make abuse difficult, and patent protection for this formulation does not expire until 2025.
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The FDA indicates that it has determined the risks of abuse outweigh any benefits provided by the original Oxycontin, since both formulations provide the same therapeutic benefits. Therefore, the agency wil not accept or approve any new drug applications for generic OxyContin.
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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.”
Painkillers are now responsible for more deaths than cocaine and heroin combined since 2003.
Last year the CDC labeled the phenomenon a “U.S. Epidemic” with more than 27,000 drug overdoses in 2007 alone.
Officials say that while the new version is more difficult to tamper with, abuse is still possible. The hope is the reformulated product will reduce the level of abuse and tampering.
Original OxyContin was approved in a time-release formula in December 1995, but was found to be highly abused by snorting or injection. The crushing of the pill allowed the drug to be quickly released into the body, causing serious side effects and resulting in widespread overdose and death. The original formula was no longer shipped by August of 2010 after the new formula was approved.
The FDA decision included the evaluation of citizen petitions, public comments, clinical data and peer-reviewed studies. The end goal is to reduce abuse of prescription drugs while remaining committed to ensuring patients with chronic pain have access to the necessary medications.
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