LAS VEGAS, NV— A study presented at PAINWeek 2012 reported that tapentadol extended-release (ER) was effective and well tolerated for managing chronic diabetic peripheral neuropathy (DPN).
The efficacy and tolerability of tapentadol ER was evaluated through pooled data from two randomized-withdrawal, placebo-controlled, Phase 3 studies (NCT00455520 and NCT01041859) in patients with moderate-to-severe, chronic painful DPN, according to Douglas Shapiro from Janssen Research & Development, Raritan, NJ.
Patients were titrated to their optimal dose of tapentadol ER (ranging from 100mg–250mg twice daily) during a 3-week open-label titration period. Those patients who had >1-point improvement in pain intensity (based on an 11-point numerical rating system) from start to end of titration were randomized to placebo (n=343) or tapentadol ER (n=360) for a 12-week double-blind maintenance period.
Study investigators found that mean (SD) pain intensity scores for placebo and tapentadol ER, respectively, were 3.48 (2.02) and 3.67 (1.85) at the start of double-blind maintenance period and 4.76 (2.52) and 3.77 (2.19) at Week 12; mean (SD) changes from the start to Week 12 of double-blind maintenance were 1.28 (2.41) and 0.08 (1.87), indicating that pain intensity worsened with placebo but was relatively unchanged with tapentadol ER. The least-squares mean difference for the change from start to Week 12 of double-blind maintenance for tapentadol ER vs. placebo was -1.14 (95% CI: -1.435 to -0.838; P<0.001).
Based on the analysis of these two Phase 3 studies, study investigators concluded that tapentadol ER is an effective option for patients managing moderate-to-severe, chronic, painful DPN.
On August 30, 2012, the FDA approved Nucynta ER for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.