FDA approves tapentadol ER for neuropathic pain associated with DPN

August 29, 2012

FDA has approved the supplemental New Drug Application for tapentadol extended-release tablets (Nucynta ER, Janssen), an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

FDA has approved the supplemental New Drug Application (sNDA) for tapentadol extended-release tablets (Nucynta ER, Janssen), 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 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% 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 8 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,” Keith A. Candiotti, MD, Professor of Anesthesiology and Internal Medicine, University of Miami School of Medicine, said in a Janssen press release. “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 2 randomized-withdrawal, placebo-controlled phase 3 trials showed, among patients who had at least a 1-point reduction in pain intensity during 3 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 mg to 250 mg 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.

Since 2008, Janssen has supported educational programs that reach a range of audiences, including patients, physicians, caregivers, parents, teens, and educators. These include: Prescribe Responsibly for physicians seeking information on the appropriate prescribing of opioid pain medications, and Smart Moves, Smart Choices to increase awareness among educators, parents, and teens about the serious problem of teen prescription drug abuse in the United States.