HONOLULU, HITapentadol extended-release (ER) is asafe and effective option for the management of moderate to severe neuropathicpain associated with diabetic peripheral neuropathy (DPN), investigatorsreported at the American Pain Society’s 31st Annual Scientificmeeting.

Christine Rauschkolb, MD, PhD, from the Janssen Research& Development, Titusville, NJ, and colleagues conducted a Phase 3,randomized-withdrawal, placebo-controlled study to evaluate the efficacy andtolerability of tapentadol ER in adult patients with moderate to severe,painful DPN with symptoms for ≥6 months who had a ≥3-month history of analgesicuse for painful DPN.


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Patients were titrated to an optimal dose (balancingefficacy and tolerability) of 100–250mg of tapentadol ER twice daily during the3-week open-label period. Following the titration period, patients with≥1-point reduction in pain intensity at the end of titration were randomized(1:1) to receive placebo or their pre-determined optimal dose of tapentadol ERfor 12 weeks (double-blind, fixed dose, maintenance phase). The primaryefficacy endpoint was mean change in average pain intensity.

Using an 11-point numerical rating scale, patientsrecorded their average pain intensity twice daily (average pain during previous12 hours) from the beginning of the study until Week 12 of the double-blindmaintenance phase (last observation carried forward). Of the 459 patientsenrolled, 358 patients completed the open-label titration period; 318 patients(placebo, n=152; tapentadol ER, n=166) were randomized and received at least onedose of study medication.

Mean (SD) pain intensity at study start versus Week 12 ofthe double-blind maintenance phase, respectively, was: tapentadol ER, 3.70(1.78) vs. 4.01 (2.23); placebo, 3.53 (2.17) vs. 4.83 (2.60). Mean (SD) changein average pain intensity from the start to Week 12 of the double-blindmaintenance phase was: tapentadol ER, 0.28 (2.04); placebo, 1.30 (2.43)(least-squares mean difference for tapentadol ER vs. placebo, –0.95 [95% CI:–1.42 to –0.49]; P<0.001 favoring tapentadol ER).

In the open-label safety population, 76.0% of patients(349 of 459) reported ≥1 treatment-emergentadverse event; those that occurred in ≥5%of patients in the tapentadol ER (vs. placebo) groups during the double-blindmaintenance included nausea (21.1% vs. 9.9%), vomiting (12.7% vs. 4.6%),fatigue (7.2% vs. 0.7%), and dizziness (7.2% vs. 2.0%).

Theinvestigators concluded that tapentadol ER dosed at 100–250mg twice daily waseffective and well tolerated for the management of moderate to severe,neuropathic pain associated with DPN in adults.