Phase III study shows tapentadol ER relieves chronic pain associated with DPN

Jan 29 2011

New research has been published indicating that patients suffering from a painful complication of diabetes may experience a significant improvement in their pain as measured by a pain intensity scale when using an investigational pain medication.  This phase III study, which evaluates the safety and efficacy of tapentadol ER against placebo for relieving moderate to severe chronic pain associated with diabetic peripheral neuropathy (DPN), is published in the January issue of the journal Current Medical Research and Opinion (CMRO). An online version of the article may be found here.

Just this past week, the Centers for Disease Control and Prevention (CDC) announced there are now nearly 26 million people in the United States living with diabetes. Over time, they can develop a type of nerve damage called neuropathy. Approximately 60 to 70 percent of people with diabetes have some form of neuropathy. The most common type is DPN, which causes pain or loss of feeling in the toes, feet, legs, hands, and arms. It is estimated that painful DPN affects 10 to 20 percent of all patients with diabetes, and many patients on current treatments still experience considerable pain.

"What's encouraging is that at the beginning of this study, the average pain rating across the entire group of patients was severe, but after three weeks on tapentadol ER, the average pain score dropped substantially to a range considered to be mild pain," said Bruce Moskovitz, MD, Therapeutic Area Leader for Pain, Ortho-McNeil-Janssen Scientific Affairs, LLC. "After double-blind randomization, the group of patients that stayed on tapentadol ER maintained its pain reduction, while the group that switched to placebo experienced a significant increase in its average pain score."