FDA Approves a New Painkiller Designed to Thwart Abusers

Drug retains effectiveness if taken as prescribed

Drug syringe and cooked heroin on spoon

The FDA approved a new chronic pain drug in July, the latest step in the FDA’s efforts to reduce the widespread abuse of extended-release/long-acting opioid painkillers.

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The drug, Targiniq ER, is for treating pain severe enough to require daily, around-the-clock, long-term treatment. It aims to treat patients who find other treatment options inadequate.

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug through snorting and injection.

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New tablet less attractive to abusers

Targiniq ER is an extended-release tablet. It blends the active narcotic ingredient oxycodone hydrochloride with the ingredient naloxone hydrochloride. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose

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. Drug abusers commonly crush a tablet to snort it or dissolve the active narcotic ingredient to inject it.

Targiniq ER can still be abused, including when taken by mouth, which is currently the most common way oxycodone is abused.

“The pharmaceutical company mixes naloxone into the pill, so that when you try to crush the pill, the naloxone is released, and then when you take the narcotic, you don’t get any benefit out of it,” says Richard Rosenquist, MD, Chairman of Cleveland Clinic’s Department of Pain Management.

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It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.

However,  its extended-release feature releases the opioid over time and not all at once.  

Past attempts haven’t curbed abuse

The FDA and drug manufacturers have tried other remedies in the past for the growing problem of painkiller abuse. They made pills more difficult to crush. They also tried delivering drugs in patch form.

However, people still found ways to abuse the drugs, Dr. Rosenquist says.

In addition to the new pill, the FDA also released new guidelines to help drug companies do a better job of making abuse-resistant or abuse-deterrent drugs.

REMS program also targets the problem

Several years ago, the FDA initiated a program known as REMS. It stands for Risk Evaluation and Mitigation Strategies. The government recognized the onslaught of abuse and attempted abuse of narcotic drugs. It wanted to address the problem in multiple ways to improve safety.

“They started to ask the industry to develop educational programs for physicians to help improve the safety around the use of some of these long-acting or high-dose narcotic pain medications and increase awareness of how to prescribe them safely,” Dr. Rosenquist says.

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“More recently, they’ve started to find ways to make the drugs themselves even more abuse-resistant by mixing other drugs into them to make it even less desirable to try to abuse those particular drugs,” he says.

If you’re a patient using these powerful narcotic painkillers, Dr. Rosenquist says, there’s really nothing that you have to do or look for. Just take them exactly as prescribed.

“You’re only going to run into a problem if you try to do something with them that you shouldn’t be doing in the first place,” he says.

He also advises making sure that you keep your prescriptions and medications in a safe place. Make sure they can’t be easily taken from a purse or from your medicine cabinet by a visitor.