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New Study Shows Tapentadol Extended Release (ER) May Significantly Reduce Average Pain Intensity for Diabetic Patients Suffering From Painful Peripheral Neuropathy
Date:1/28/2011

point rating scale their overall status at the end of treatment relative to the beginning of trial treatment (NRS; 1='very much improved,' 7='very much worse').  At the end of double-blind treatment, 64.4 percent of patients receiving tapentadol ER and 38.4 percent of patients receiving placebo reported that their overall status was 'very much improved' or 'much improved' (p<0.001) on the PGIC.

In addition, from the start to the end of the open-label titration phase, 60.5 percent (356/588) of patients reported at least a 30 percent improvement in pain intensity.

This phase III, randomized-withdrawal trial evaluated the safety and efficacy of tapentadol ER for relieving painful DPN versus placebo in 588 patients. Patients had at least a 3-month history of opioid and/or non-opioid analgesic use for DPN, dissatisfaction with current treatment, and an average pain intensity score of at least 5 on the 11-point NRS.

The most common treatment-emergent adverse events (TEAEs) during the open-label phase were nausea (21.4 percent), dizziness (15.8), somnolence (15.1), constipation (10.7), vomiting (8.0), headache (7.8), fatigue (7.0) and pruritus (6.6). In the double-blind period with tapentadol ER, the most common TEAEs that occurred included nausea (13.8 percent), anxiety (9.2), diarrhea (8.2), and dizziness (7.7). During the double-blind treatment period, the overall incidence of TEAEs was similar for male and female patients who received tapentadol ER and the overall incidence of TEAEs was likewise similar for patients under 65 years of age and over 65 years of age who received tapentadol ER during double-blind treatment.

The safety profile of tapentadol ER in this study, especially the incidence of nausea, vomiting, and constipation during the open-label phase, was similar to previous findings from other phase III, randomized, double-blind efficacy and safety trials of tapentadol ER for nociceptive pain, including chronic low back
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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