Janssen announced that the FDA has approved the supplemental New Drug Application (sNDA) for Nucynta ER (tapentadol extended-release) tablets 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 currently the only FDA-approved opioid for neuropathic pain associated with DPN.
This approval was based on data from two randomized-withdrawal, placebo-controlled Phase 3 trials that demonstrated patients having at least one-point reduction in pain intensity during three weeks of treatment with Nucynta ER. Also, patients who continued on the same dose of Nucynta ER that was later titrated to 100–250mg twice daily for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo.
Nucynta ER, a centrally-acting synthetic analgesic, is already 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.
For more information call (800) JANSSEN or visit www.nucynta.com.