Tags: targiniq er | approved | fda | extended-release | oxycodone

Targiniq ER: Extended-Release Oxycodone Drug Approved for Use by FDA

Image: Targiniq ER: Extended-Release Oxycodone Drug Approved for Use by FDA
U.S. Food and Drug Administration (FDA). (PRNewswire)

By    |   Thursday, 24 Jul 2014 03:47 PM

An extended-release, long-acting oxycodone drug called Targiniq ER was approved for use Thursday by the U.S. Food and Drug Administration. It is intended to treat severe, long-term pain.

The drug, which is an oxycodone hydrochloride and naloxone hydrochloride tablet, is the second opioid to be approved by the FDA that has abuse-deterrent properties as laid out by the government watchdog agency in 2013, an FDA press release said.

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"Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection," the FDA said. "When crushed and snorted, or crushed, dissolved, and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone."

The drug can still be abused when it is taken orally, the most common way oxycodone is abused, the release said.

"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” said Sharon Hertz, M.D., a deputy director in the FDA’s Center for Drug Evaluation and Research, in the release. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”

Despite the steps taken with Targiniq ER, addiction experts say the drug shouldn’t be labeled as deterring abuse.

By chewing the tablet, individuals can get a 12-hour oxycodone dose easily, said Andrew Kolodny, M.D., chief medical officer of a substance abuse rehab program.

"This product is obviously inferior to OxyContin and should certainly not be labeled abuse-deterrent," Kolodny told MedPage.

Targiniq ER is manufactured by Stamford-based Purdue Pharma L.P., which also manufactures oxycodone.

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An extended-release, long-acting oxycodone drug called Targiniq ER was approved for use Thursday by the U.S. Food and Drug Administration. It is intended to treat severe, long-term pain.
targiniq er, approved, fda, extended-release, oxycodone
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2014-47-24
Thursday, 24 Jul 2014 03:47 PM
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