Reuters: Regulatory News: FDA approves wider use for J&J Nucynta ER pain drug

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FDA approves wider use for J&J Nucynta ER pain drug Aug 29th 2012, 17:10 Wed Aug 29, 2012 1:10pm EDT * Approved for nerve damage caused by diabetes * First opioid drug for the condition WASHINGTON Aug 29 (Reuters) - Johnson & Johnson unit Janssen Pharmaceuticals said on Wednesday it received U.S. regulatory approval for a wider use of its painkiller Nucynta ER, for nerve damage brought on by diabetes. Nucynta ER, an opioid, is already approved for extended use in moderate to severe chronic pain. But the expanded approval from the U.S. Food and Drug Administration allows Janssen to market the drug for diabetic peripheral neuropathy, which affects up to 8 million Americans. Some studies estimate that nearly half of all people with diabetes have some form of peripheral neuropathy, which can cause stinging or burning sensations, pain, numbness or weakness in the hands and feet, and is a major cause of amputations. Janssen said only two other drugs were approved for pain related to the condition, but Nucynta ER is the first approved opioid. The FDA and other health officials have recently warned about the potential for abuse with opioids -- synthetic versions of opium that can be highly addictive, especially when taken over a long period of time. Some researchers have said aggressive marketing by drug companies has fueled overprescribing of opioids like oxycodone and methadone. In a statement announcing the approval, Janssen said it was committed to teaching doctors, patients and others about the responsible use of painkillers and the prevention of misuse. Nucynta's common side effects include nausea, constipation, vomiting, dizziness, headaches and drowsiness. Like some other opioids, the twice-daily pill in rare cases may also cause life-threatening respiratory depression. Johnson & Johnson shares were up 0.3 percent at $67.72 in afternoon trading on the New York Stock Exchange. Link this Share this Digg this Email Reprints

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