Janssen Pharmaceuticals today announced that the FDA has approved the supplemental new drug application for tapentadol extended release, an oral analgesic indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.
Tapentadol (Nucynta ER, Janssen Pharmaceuticals) is currently the first and only opioid approved by the FDA for neuropathic pain associated with diabetic peripheral neuropathy, according to a press release issued by the manufacturer.
The agency’s decision is supported by data from two randomized-withdrawal, placebo-controlled phase 3 trials. Study results showed that, among patients who experienced at least a one-point reduction in pain intensity during 3 weeks of treatment with tapentadol ER, those who continued on the same dose 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 when compared with those who switched to placebo. Findings also demonstrated that tapentadol ER was generally well tolerated. The most common adverse reactions were nausea, constipation, vomiting, dizziness, headache and somnolence, according to the release.
Tapentadol is a centrally acting synthetic analgesic. Although the mechanism of action is unclear, preclinical studies indicate that tapentadol ER acts as a mu-opioid receptor and a norepinephrine reuptake inhibitor.
“Pain from diabetic peripheral neuropathy can be difficult to manage, leaving some patients and health care professionals looking for alternative treatments,” Keith A. Candiotti, MD, professor of anesthesiology and internal medicine at the University of Miami School of Medicine, said in the release. “Nucynta ER is a different option than currently approved medications for the management of painful diabetic peripheral neuropathy and may be an important new choice for these patients.”
Disclosure: Dr. Candiotti has been a paid consultant to Janssen Pharmaceuticals.