FDA Gives Market Nod to J&J Pain Drug
The approval follows J&J's study showing the safety and efficacy of the drug in Phase III studies.
U.S. regulators have approved J&J unit Janssen's extended-release version of pain pill Nucynta. The company can now market the drug for moderate to severe chronic pain in adults who need continuous treatment with an opioid analgesic.
Chronic pain is a big problem in the U.S. More than 42 million Americans over the age of 20 suffer from chronic pain, which is also a leading cause of disability.
The approval follows J&J's study showing the safety and efficacy of the drug in Phase III studies involving patients with chronic low back pain and serious aches from diabetic peripheral neuropathy. The drug also proved safe in more than 1,100 patients with chronic pain.
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