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FDA Approves Purdue's Painkiller that Can Reduce Abuse

November 20, 2014

By Toni Clarke

The U.S. Food and Drug Administration has approved a long-acting narcotic painkiller with abuse-resistant properties made by Purdue Pharma L.P., the agency said on Thursday.

The FDA approved the once-daily drug, hydrocodone bitartrate (Hysingla ER), with the expectation that it will reduce, though not necessarily prevent, abuse through snorting or injecting.

It is the second extended-release single-entity hydrocodone drug approved by the FDA. The first, approved last October, was Zohydro ER, made by San Diego-based Zogenix Inc.

Other hydrocodone drugs, such as Vicodin, combine short-acting hydrocodone with acetaminophen or other painkillers.

The approval comes at a time of rising prescription drug abuse. Of the 22,114 drug overdose deaths in 2012, 72% involved opioid analgesics such as hydrocodone, according to the Centers for Disease Control and Prevention.

The FDA's approval of Zohydro, against the advice of its own advisory committee, prompted criticism that the drug would fuel prescription painkiller abuse. Long-acting opioid formulations carry greater risks of overdose than short-acting formulations.

One of the criticisms of Zohydro is that it is not available in abuse-resistant form. It can be crushed, snorted and injected.

Stamford, Connecticut-based Purdue's product, by comparison, is designed to deter abuse. The pill is harder than most pills, making it difficult to crush. If someone tries to cut it into small pieces and dissolve, it will turn gooey.

How effective the drugs are in reducing opioid abuse in the real world remains to be seen.

Purdue's drug is the fourth painkiller with abuse-resistant properties to be approved by the FDA. In July the agency approved Targiniq ER, a drug also made by Purdue that includes the painkiller oxycodone and naloxone, a drug that blocks the euphoric effects of oxycodone.

Last year the FDA approved Purdue's abuse-deterrent OxyContin while simultaneously withdrawing the original, widely abused version.

The FDA recently approved abuse-deterrent labeling for Pfizer Inc's painkiller Embeda, a drug to treat opioid dependence. Pfizer expects the drug to be available in the U.S. in early 2015. Embeda was recalled in 2011 due to a flaw in the manufacturing process.


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