Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for NUCYNTA® ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
NUCYNTA® ER is the first and only opioid approved by the FDA for neuropathic pain associated with DPN. In addition to this new indication, NUCYNTA® ER is currently approved for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Diabetes affects nearly 26 million people in the United States, and approximately 60 to 70 percent of people with diabetes have some form of neuropathy. The most common type of neuropathy is DPN, which causes pain or loss of feeling in the toes, feet, legs, hands and arms; it may also include a persistent burning, tingling or prickling sensation. It is estimated that DPN affects nearly eight million people in the United States. Because the complex pathophysiology of DPN involves both central and peripheral mechanisms, certain patients with DPN may require treatment with multiple agents.
“Pain from DPN can be difficult to manage, leaving some patients and healthcare professionals looking for alternative treatments,” said Keith A. Candiotti, M.D., Professor of Anesthesiology and Internal Medicine, University of Miami School of Medicine.* “NUCYNTA® ER is a different option than currently approved medications for the management of painful DPN and may be an important new choice for these patients.”
NUCYNTA® ER is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that NUCYNTA® ER acts as both a mu-opioid receptor and a norepinephrine reuptake inhibitor.
Data from two randomized-withdrawal, placebo-controlled Phase 3 trials showed, among patients who had at least a one-point reduction in pain intensity during three weeks of treatment with NUCYNTA® ER, those who continued on the same dose of NUCYNTA® ER that was titrated to balance individual tolerability and efficacy (100-250mg twice daily) for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo. The findings also demonstrated that NUCYNTA® ER was generally well tolerated. The most common (≥10% of NUCYNTA® ER treated patients) adverse reactions were nausea, constipation, vomiting, dizziness, headache and somnolence.
“The approval of NUCYNTA® ER for DPN pain represents the ongoing commitment of Janssen to bring new and innovative products to patients and physicians for the management of pain,” said Paul Chang, Vice President, Medical Affairs, Janssen Pharmaceuticals, Inc. “It is exciting that our in-depth experience in pain management allows us to continue to provide patients with effective options to treat their pain.”
Source: Janssen Pharmaceuticals, Inc.