Positive Ph III results for J&J's Nucynta in diabetic peripheral neuropathy

Janssen Pharmaceuticals, a unit of health care major Johnson & Johnson yesterday announced the results of an investigational Phase III study suggesting that Nucynta ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy (DPN). Results of the study were presented at the 31st Annual Scientific Meeting of the American Pain Society being held May 16-19 in Honolulu, Hawaii.

The US Food and Drug Administration approved tapentadol immediate-release tablets, which J&J sells under license from Germany’s Grunenthal, for the relief of moderate-to-severe acute pain in adults 18 years of age or older in 2008. The FDA later cleared Nucynta 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 (The Pharma Letter August 30, 2011).

Diabetes affects nearly 26 million people in the USA - and its prevalence is expected to grow significantly during the coming decades. Over time, people with diabetes can develop a type of nerve damage called neuropathy. Around 60% to 70% of people with diabetes have some form of neuropathy, the company explained, adding that the most common type is diabetic peripheral neuropathy, which causes pain or loss of feeling in the toes, feet, legs, hands, and arms.