J&J submits new FDA application for Nucynta ER

Drug maker seeks approval for drug in adults with DPN

TITUSVILLE, N.J. — A Johnson & Johnson subsidiary has sent a regulatory application to the Food and Drug Administration seeking approval for one of its drugs in treating diabetes-related pain.

J&J Pharmaceutical Research & Development announced Monday the submission of its supplemental new drug application for Nucynta ER (tapentadol) extended-release tablets. The company hopes the FDA will approve the drug for managing neuropathic pain related to diabetic peripheral neuropathy in adults. The FDA approved the drug for managing moderate to severe chronic pain in adults who require a continuous, around-the-clock opioid treatment.

Of the nearly 26 million Americans living with diabetes, about 60% to 70% of them have some form of neuropathy, of which diabetic peripheral neuropathy is the most common type, according to J&J. The condition causes pain or loss of feeling in the toes, feet, legs, hands and arms.

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