* Approved for nerve damage caused by diabetes
* First opioid drug for the condition
WASHINGTON Aug 29 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
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
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.