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Nucynta painkiller approved by FDA after research into crush-resistant formula


The Food and Drug Administration approved Johnson & Johnson’s extended-release version of Nucynta, an opioid painkiller drug the company began distributing in 2008.

Nucynta ER is designed to be taken twice daily and, like other opioid painkiller drugs, holds the risk of addiction and dependence among its users. The immediate-release version that has been available for three years is marketed to adults 18 and older who have severe acute pain. The new extended-release version is for moderate to severe chronic pain.

Johnson & Johnson reported that in October 2010 the FDA requested additional information on the conversion of the extended-release version of the drug to a form that was crush-resistant. Because Nucynta is a schedule II drug, it has a high potential for physical and psychological dependence. In addition, consumers can abuse the drug recreationally.

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Prescription drug abuse has become a bigger problem in the U.S. in recent years. According to the National Institute on Drug Abuse, roughly 5.3 million people in the U.S. use prescription painkillers. Nearly one in 12 high school seniors reported nonmedical use of the well-known painkiller Vicodin and one in 20 reported using OxyContin without a prescription in 2009.

Prescription opioids, like Nucynta, act on the same receptors as the street drug heroin, and can be one of the most highly addictive drugs available. Because of their addictive quality, newer methods to keep users from abusing them are highly valued. Over the years there have been many attempts to make drugs abuse-proof. In the late 1990s, when OxyContin was released, its manufacturer claimed that because the drug had a controlled-release factor, it would be less likely to be abused. A decade and a half later, OxyContin is one of the most abused prescription opioids available.

Chewing tablets, crushing them or dissolving and injecting them are the most common forms of abuse. With the new form of Nucynta ER, the formula has been changed to increase the resistance to crushing or breaking. Changing formulas to make pills crush resistant is becoming a more common trend in the fight against prescription painkiller abuse.

One way drug companies make pills more crush-resistant is by combining agonists with antagonists, like adding naltrexone to oxycodone, or combining the opioid with aversive agents, like niacin. OxyContin 2.0 is a prime example of a crush-resistant drug. It’s resin-based, which makes it both difficult to pound into powder and harder to dissolve into water.

Nucynta ER in its new abuse-resistant form is now available to consumers. Johnson & Johnson’s Janssen Pharmaceuticals Inc. developed the drug along with the privately-held German company Grunenthal GmbH, which discovered the compound.