The U.S. FDA has approved the supplemental New Drug Application (sNDA), submitted by Janssen Pharmaceuticals, for NUCYNTA ER (tapentadol) extended-release tablets. NUCYNTA ER is 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.
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.
