Favorable Results With Lacosamide For Use In Diabetic Neuropathic Pain

June 5, 2006

The primary endpoint for the lacosamide target dose was at the

statistically significant level when the investigational agent was

evaluated for the treatment for painful diabetic neuropathy in a

recent phase 3 trial.

Aziz Shaibani, MD, Director of the Nerve and Muscle Center of Texas

in Houston, presented the data recently at the 25th Annual Meeting of

the American Pain Society (APS).

Lacosamide is being studied as an anticonvulsant with potential for

reducing diabetic neuropathic pain. Diabetic neuropathic pain affects

about eleven million diabetics worldwide, and the incidence of the

condition increases with age. Nearly 50 percent of individuals who

have had diabetes for over 25 years will experience some symptoms of

painful diabetic neuropathy.

Dr. Shaibani's team randomized 469 patients with pain due to distal

diabetic neuropathy to twice-daily oral lacosamide or placebo across

four different treatment arms: placebo; lacosamide, 200 mg/d;

lacosamide, 400 mg/d; and lacosamide 600 mg/d, in a 1:2:2:2 ratio,

respectively.

Subjects were treated for a maximum of 20 weeks.

The primary efficacy variable was the within-subject change in the

average daily pain score from the baseline week to the last four

weeks of the 12-week maintenance phase using the widely validated

Likert Scale.

Results showed that the target lacosamide dose of 400 mg/d approached

statistical significance, p=0.0507.

Lacosamide at 400 mg/d and 600 mg/d significantly lowered pain scores

throughout the treatment and maintenance periods.

The 200 mg/d and 400 mg/d doses were better tolerated than the 600

mg/d dose.

Elsewhere at the meeting, researchers reported that lacosamide has

low potential for drug-drug interactions.

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

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