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Title: Lacosamide Demonstrates Strong Potential for Management of Diabetic Neuropathic Pain: Presented at APS

"Lacosamide Demonstrates Strong Potential for Management of Diabetic Neuropathic Pain: Presented at APS"

By Elizabeth Nicholas SAN ANTONIO, T.X. -- May 5, 2006 -- New data from a phase 3 trial show that the primary end point for the lacosamide target dose reached a statistical significance level when the investigational compound was tested as a treatment for patients with painful diabetic neuropathy. Lacosamide, formerly known as SPM 927, is being studied as an anticonvulsant with potential for reducing diabetic neuropathic pain. The results were reported here on May 5[^th at the 25^th Annual Meeting of the American Pain Society (APS).

Aziz Shaibani, MD, director, Nerve and Muscle Center of Texas, Houston, Texas, and colleagues randomized 469 patients with pain secondary to distal diabetic neuropathy to a maximum of 20 weeks of twice-daily oral lacosamide or placebo across 4 different treatment arms in a 1:2:2:2 ratio, respectively: placebo; lacosamide 200 mg/day; lacosamide 400 mg/day; and lacosamide 600 mg/day.

At enrollment, all subjects had an average daily pain score of 4 or greater on an 11-point Likert scale, a validated pain discomfort measure in which a score of 0 refers to no pain and 10 denotes unbearable pain.

The treatment groups were similar with respect to gender, age, and body mass index.

The primary efficacy variable was the within-subject change in the average daily Likert pain score from baseline to the last 4 weeks of the 12-week maintenance phase.

The results show that the target lacosamide dose of 400 mg/day approached statistical significance (P =.0507). Lacosamide at 400 mg and 600 mg lowered pain scores significantly throughout the treatment and maintenance periods.

The 200 mg and 400 mg doses were better tolerated than the 600 mg dose.

Diabetic neuropathic pain affects about 11 million diabetics worldwide.

The study was funded by Schwarz Pharma in Monheim, Germany.

[Presentation title: A Multi-Center, Randomized Double-Blind, Placebo-Controlled Parallel-Group Trial to Assess the Efficacy and Safety of SPM (200, 400,and 600 mg/d) in Subjects With Painful Diabetic Neuropathy. Abstract 774]

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