LAS VEGAS, NV—Use of tapentadol extended-release (ER) tablets is efficacious in the management of moderate-to-severe chronic pain associated with diabetic peripheral neuropathy in adults, according study results presented at PAINWeek 2012.
Douglas Y. Shapiro, MD, from Janssen Research & Development, Raritan, NJ, and colleagues conducted a Phase 3, randomized-withdrawal, placebo-controlled study (NCT01041859) that evaluated the efficacy and tolerability of tapentadol ER for the management of neuropathic pain associated with diabetic peripheral neuropathy.
Adult patients with painful symptoms for >6 months and with a >3-month history of analgesic use for painful diabetic peripheral neuropathy were titrated to an optimal dose of tapentadol ER (100 mg–250 mg twice daily) during a 3-week open-label period. Patients with >1 point reduction in pain intensity (on an 11-point numerical rating scale) were later randomized to receive placebo or their optimal dose of tapentadol ER for 12 weeks (double-blind, fixed-dose, maintenance phase).
The primary efficacy endpoint was mean change in average pain intensity from start to Week 12 of the double-blind maintenance phase. Of the 358 patients enrolled, 318 patients were randomized and received >1 dose of study medication. Mean (SD) change in average pain intensity from the start to Week 12 of the double-blind maintenance phase was: tapentadol ER, 0.28 (2.042); placebo, 1.30 (2.428). The least-squares mean difference for tapentadol ER vs placebo was -0.95 (95% CI: -1.415 to -0.493; P<0.001). In addition, patient global impressions of change (PGIC) scores were significantly better with tapentadol ER vs placebo. The mean (SD) change in the pain interference score of the brief pain inventory-short form (BPI-SF) from an open-label start to double-blind endpoint was -2.6 (2.38) for placebo and -3 (2.07) for tapentadol ER (P=0.05).
Researchers concluded that compared with placebo, tapentadol ER (100 mg–250 mg twice daily) provided significant improvements in PGIC and BPI-SF, and proved to be effective and well tolerated for the management of moderate-to-severe, chronic, painful diabetic peripheral neuropathy.
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.