* Approved for pain due to nerve damage caused by diabetes
* First opioid drug for the condition
WASHINGTON Aug 29 Johnson & Johnson
unit Janssen Pharmaceuticals said o n W ednesday 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
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. Th e 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
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 0.1 4 percent at $ 67. 37 in
late trading on the New York Stock Exchange.