FDA bans generic version of original OxyContin
No generic forms of the original formula of OxyContin will be approved in the U.S., the Food and Drug Administration announced on Tuesday.
In addition, the FDA said that they have approved updated labeling for a reformulated version of OxyContin. The controlled-release version of OxyContin has physical and chemical properties that will theoretically deter people from injecting or snorting the pills.
"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said in a press release. "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."
OxyContin (oxycodone hydrochloride), which is manufactured by Purdue Pharma, was first approved in December 1995. The opioid medication is an effective pain reliever made from thebaine, which is found in poppies. The patent for the original formula of the drug expired on Tuesday, and three other drug makers were aiming to produce generic versions.
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The medication is often abused, with many people finding ways to manipulate the extended release qualities. This allows the active ingredients to be released quicker, and can lead to adverse reactions like overdose and death. Opioid drugs were cited in a JAMA study in February 2013 as the most frequently abused in overdose deaths in 2010, accounting for three out of four medication-related demises.
Because of the high rate of abuse, Purdue stopped sending the original form of OxyContin to pharmacies in August 2010.
The new formula is harder to crush, break or dissolve, and forms a thick, sticky water-like gel substance so it cannot be easily injected. This doesn't rule out that these pills can be abused in these ways, however, or even by simply taking more of the medication orally.
The FDA will also require that all generic medication will have these abuse-deterrent aspects as well.
There has been some negative reaction to the new formula of OxyContin. A letter published in July 2012 in the New England Journal of Medicine explained that because the updated formula made it harder to abuse, addicts across the U.S. are switching to heroin, which has similar properties to the medication.
Before the release of the abuse-deterrent formula, the study revealed 35.6 percent of survey respondents said it was their drug of choice. Twenty-one months after the new formula was released, only 12.8 percent said they preferred the medication over other drugs. Sixty six percent of the survey takers who said they had abused both versions of the drug said they switched to another opioid, with heroin being the most frequent response. Twenty-four percent said they found a way to abuse the drug, despite the new deterrents.
"Most people that I know don't use OxyContin to get high anymore. They have moved on to heroin (because) it is easier to use, much cheaper, and easily available," one survey responder said.
The agency explained that their decision to ban generic versions of the original OxyContin formula came about because of citizen petitions asking if the original OxyContin was voluntarily withdrawn from the market because of other reasons besides safety and effectiveness, in addition to other public comments. The FDA also considered information about the original and new formulas of OxyContin, as well as clinical data, peer-reviewed literature and other evidence about adverse events associated with the original OxyContin and other extended-release oxycodone products.
Rep. Hal Rogers (R-Ky.) applauded the FDA's decision. He had spoke on the House floor on Tuesday before the announcement asking the FDA to take action before the patent expired.
The FDA undoubtedly saved our nation from another deadly tidal wave of oxycodone abuse and overdoses," Rogers, co-chairman of the Congressional Caucus on Prescription Drug Abuse, said to USA Today. "I commend Dr. Hamburg for leading the way and pressing forward to ensure that this original, deadly patent didn't expire without the mechanisms to significantly prevent abuse and misuse of these drugs."
