WASHINGTON Johnson & Johnson unit Janssen Pharmaceuticals said on Wednesday it received U.S. regulatory approval for a wider use of its Nucynta ER painkiller, for pain from 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 pain tied to 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.
Sales of the non-extended release version of Nucynta were $140 million in 2011 and are expected to reach $600 million in 2016, according to the average forecast of analysts polled by Thomson Reuters. The company did not immediately provide sales figures for Nucynta ER.
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 pain-killers 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 down 0.14 percent at $67.37 in late trading on the New York Stock Exchange.
(Reporting by Anna Yukhananov)