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Title: Extended-Release Tapentadol Confers Sustained Improvements in Painful Diabetic Peripheral Neuropathy: Presented at ADA

"Extended-Release Tapentadol Confers Sustained Improvements in Painful Diabetic Peripheral Neuropathy: Presented at ADA"

By Jill Stein NEW ORLEANS -- June 6, 2009 -- Patients who respond initially to the investigational extended-release (ER) formulation of tapentadol for the treatment of their diabetic neuropathic pain (DPN) experience ongoing benefit throughout 12 additional weeks of treatment, according to data reported here today at the American Diabetes Association (ADA) 69th Scientific Sessions. Pure mu-opioids such as oxycodone and morphine have been used for the management of pain in patients with DPN but are widely associated with a variety of gastrointestinal and central nervous system adverse effects that may cause patients to stop taking their medication. Mila Etropolski, MD, Chronic Pain Product Development, Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey, and colleagues tested the use of tapentadol ER in patients with moderate to severe pain due to chronic DPN. The study included 588 patients who were initially titrated to an optimal dose of oral tapentadol ER 100 to 250 mg BID during a 3-week, open-label (OL) phase. Patients with >=1-point decrease in pain intensity on an 11-point numeric rating scale (NRS) were then randomised to placebo or tapentadol ER for 12 weeks for the double-blind (DB) phase. During the DB phase, 193 patients were assigned to placebo and 196 were assigned to fixed BID doses of tapentadol ER (100 mg, n = 30; 150 mg, n = 34; 200 mg, n = 26; 250 mg, n = 106). The primary efficacy endpoint was the change from baseline at randomisation in mean pain intensity from the start of the study to week 12 of the DB phase, as determined by twice-daily measurements on the NRS. Results revealed that patients receiving tapentadol ER maintained the improvement observed in the OL phase, while placebo-treated patients significantly worsened from the start of the DB phase (least-squares mean difference between treatment groups of 1.31; [P < .001).

Tapentadol ER was well tolerated, as evidenced by a relatively low rate of study discontinuations due to treatment-emergent adverse events (TEAs). TEAs that began during the double-blind phase and led to study discontinuation were reported by 5.7% of patients in the placebo group and 11.2% of patients in the tapentadol ER group.

Dr. Etropolski said that the study profile of tapentadol ER was consistent with the profile expected for centrally acting analgesics with mu-opioid activity and was similar to the profile of tapentadol ER in previously completed phase 3 trials in patients with moderate or severe osteoarthritis pain and low back pain.

Overall, the data demonstrate that tapentadol ER 100 to 250 mg BID was safe and effective for the management of chronic neuropathic pain in patients with DPN, she added.

Funding for this study was provided by provided by Johnson & Johnson.

[Presentation Title: Safety and Tolerability of Tapentadol Extended Release (ER) in Patients With Painful Diabetic Neuropathy (DPN): Results of a Randomized-Withdrawal Phase 3 Study. Abstract 852-P]

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