New abuse-deterrent painkiller approved

Photo provided by David Rust/CNN
Thursday, July 24, 2014 - 9:00am

In the painkiller world, oxycodone and naloxone will seem like strange bedfellows. Oxycodone is a powerful painkiller, while naloxone is used to reverse painkiller overdose.

A drug combining the two, called Targiniq ER, was approved by the Food and Drug Administration Wednesday.

The drug's maker, Purdue Pharma, said the combination is, "...intended to simultaneously alleviate pain while also introducing a new method by which to help deter misuse and abuse."

Oxycodone is one in a group of powerful painkillers -- called opioid analgesics -- that include hydrocodone, morphine, and hydromorphone. It provides pain relief by binding to receptors in the brain that dull the sensation of pain.

So why marry it with naloxone? Simply put, naloxone can unseat oxycodone on those same brain receptors, blocking oxycodone's ability to provide pain relief.

In the case of Targiniq, that happens only when the pill is crushed. If the pill remains intact, naloxone lies dormant, allowing oxycodone to do its work.

Approval of an abuse-deterrent painkiller like Targiniq would seem welcome, considering rampant use of the drugs in the United States. The United States consumes 83% of the world's oxycodone and 99% of its hydrocodone, according to a 2010 International Narcotics Control Board report.

Forty-six people die each day from prescription painkiller overdoses, according to the Centers for Disease Control and Prevention.

And abuse-deterrence seemed to work with another of Purdue Pharma's painkillers, OxyContin: A difficult-to-crush version of the drug was introduced in 2010.

"Before that, OxyContin was the most commonly diverted and abused drug," said Caleb Banta-Green, an opioid overdose researcher and former senior science adviser to the Office of National Drug Control Policy. "After the formulation changed, nobody liked it because they couldn't abuse it."

According to the New England Journal of Medicine, before 2010, OxyContin had been considered a primary drug of abuse for about 36% of people surveyed. Twenty-one months after the introduction of the abuse-deterrence version, only 13% abused it.

What impact Targiniq's approval could have on oxycodone abuse remains to be seen.

Targiniq's approval, "...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," said Dr. Sharon Hertz, deputy director of the Division of Anesthesia, Analgesia and Addiction Products at the FDA, in a press release.

The FDA stressed that the drug should be prescribed as a last resort, for patients who have exhausted all other attempts to relieve their pain.

Still, addiction experts fear that Targiniq could still be easily abused, and the fact that naloxone is only activated when the pill is crushed could give prescribers and patients a false sense of security.

"When the pills are swallowed they are as addictive and dangerous as pure oxycodone," said Andrew Kolodny, chief medical officer of the Phoenix House, an alcohol and drug abuse treatment provider.

And the fear is that people who abuse or misuse opioids (also called opiates) will simply find another route to a high.

"In a sense it's playing a game of 'whack a mole,' because if people are addicted to opiates, they will find an opiate," said Caleb Banta-Green, senior research scientist at the Alcohol and Drug Abuse Institute at the University of Washington.

"This (drug approval) could and will likely help, but it doesn't fix the inherent problem that people addicted to opiates will continue to use them."

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