Source: DGNews  |  Posted 1 year ago

By Ed Susman

ROME -- June 20, 2010 -- The prolonged release formulation of tapentadol relieved pain caused by osteoarthritis, low back pain, and diabetic neuropathy pain in a series of studies, researchers said here at the 2010 Annual Meeting of the European League Against Rheumatism (EULAR).

"We are seeking an indication for general chronic pain conditions for tapentadol prolonged release," said Christine Rauschkolb, MD, Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey, during a poster presentation on June 17.

Dr. Rauschkolb and associates reviewed results of 5 company-sponsored studies using tapentadol prolonged release tablets in doses ranged from 100 to 250 mg twice a day in patients with a variety of pain complaints. The researchers included 3 studies involving osteoarthritis pain, 1 study that looked at treatment for low pack pain, and 1 study of patients complaining of diabetic neuropathy pain.

The researchers found that when compared with placebo tapentadol prolonged release significantly reduced pain intensity from baseline throughout maintenance in the low back pain study. That study involved 965 patients with a mean age of 49.9 years. Patients taking tapentadol prolonged release had a mean reduction of 0.7 points when compared with placebo patients over the year-long course of the study (P < .001).

Two arms of the study involved doses of tapentadol; another group received oxycodone controlled-release tablets. Tapentadol proved more beneficial in that study, reducing pain scores about 0.8 points (P < .001).

In one osteoarthritis study, 1,023 patients participated and those on tapentadol prolonged release achieved a 0.7 decrease in their pain scores compared with placebo (P < .001); patients on oxycodone had a smaller decrease in pain, but it also reached statistical significance (P = .049). In a second osteoarthritis study involving 987 patients, treatment with tapentadol failed to reach statistical significance (P = .135). Results were similar for oxycodone in this patient population (P = .421).

In the diabetic peripheral neuropathy study that enrolled 389 patients, there was no change in average pain intensity from the start to week 12 of maintenance with tapentadol prolonged release, while pain intensity worsened with placebo (P < .001), indicating significant efficacy for tapentadol.

In the 1-year study of patients with that involved 1,095 patients who complained of osteoarthritis or back pain, observed back pain showed improvement when on tapentadol or oxycodone in comparison with placebo.

"Treatment with tapentadol prolonged release was consistently effective for both nociceptive and neuropathic chronic pain types over 15-week and 1-year treatment periods," Dr. Rauschkolb said.

Funding for this study was provided by Johnson & Johnson.

[Presentation title: Efficacy of Tapentadol Prolonged Release (PR) for the Management of Chronic Nociceptive and Neuropathic Pain in Phase 3 Studies. Abstract THU0433]