New Lacosamide Data Provides Evidence for Long-Term Efficacy in Diabetic Neuropathic Pain

Results presented at the 27th Annual Meeting of the American Pain Society (APS)

By UCB

"This is the first placebo-controlled trial of a diabetic neuropathic pain treatment providing evidence of long-term efficacy for more than one year in a withdrawal setting," said Tibor Hidvegi, MD, Medical Department, Petz Aladar Hospital, Gyor, Hungary. "These results are promising because more treatment options are needed for DNP, a debilitating complication of diabetes that can leave patients in discomfort."

Study Design

This placebo-controlled, withdrawal study was a sub-trial of an open- label, follow-on (SP746) to a Phase III, double-blind trial (SP743). Patients had been followed for at least 16 months (mean 20 months) before entering the sub-trial. Prior to any lacosamide treatment, patients had an average daily pain score of 6.5. After more than a year of open-label treatment, the mean pain score was 2.5, the baseline score of the withdrawal sub-trial.

A total of 106 patients treated with lacosamide (100-400 mg/day) participated in the withdrawal study. In a blinded fashion, lacosamide treatment was withdrawn (less than or equal to 28 days) and reintroduced to these patients.

The primary endpoint was the change in average daily pain score from baseline (seven days prior to randomization) to the last seven days of each period, using the 11-point Likert pain scale, which ranges from zero (no pain) to 10 (worst possible pain).

Study Results

The difference in average daily pain scores between lacosamide and placebo was statistically significant and favored lacosamide (p= 0.007). In addition, average daily pain scores increased during placebo treatment and improved to values similar to sub-trial baseline (2.5 on the pain scale) when lacosamide was reintroduced. These findings indicate that, even after 16 months of treatment, lacosamide was still effectively treating pain.

Secondary endpoints indicated a worsening of pain when lacosamide was withdrawn. The intra-individual change in average daily pain score from open-label lacosamide treatment at baseline to the end of the placebo period was statistically significant (p<0.001). More subjects receiving placebo (39%) versus lacosamide (29%) experienced sustained worsening of pain during the withdrawal periods. Similarly, more subjects receiving placebo exited the withdrawal periods early due to increased pain than subjects receiving lacosamide (15% vs. 9%).

The trial revealed no new safety concerns with lacosamide, and there was also no evidence of withdrawal effects following abrupt discontinuation of lacosamide.

About lacosamide

Lacosamide has a dual mode of action and is the first agent of its kind to be clinically studied for the treatment of diabetic neuropathic pain. It selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target -- collapsin-response mediator protein-2 (CRMP-2). Lacosamide is also being investigated for its potential to treat partial onset seizures in adults with epilepsy.

Lacosamide oral tablet has been filed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of diabetic neuropathic pain. Applications for marketing authorization for lacosamide are supported by data from placebo-controlled clinical trials of more than 1,000 people with diabetic neuropathic pain. In these trials significant and sustained reductions in pain scores were seen versus placebo. The most common adverse events of lacosamide (greater than or equal to 10%) reported in these trials included dizziness and nausea.

About Diabetic Neuropathic Pain

Diabetic neuropathic pain is a painful and potentially debilitating complication of diabetes often characterized by a stabbing or burning sensation in the legs, feet and/or hands. It is caused by damage or dysfunction to the peripheral nervous system as a result of diabetes or impaired glucose tolerance. Diabetic neuropathic pain often substantially interferes with sleep, recreational activities, mobility, and normal work and social activities, and many patients with the condition experience a significantly reduced quality of life. With the overall prevalence of diabetes in the U.S. estimated at 20.8 million people, it is thought that as many as 7.7 million have some degree of diabetic neuropathic pain.

About UCB

UCB (Euronext: UCB) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. Employing approximately 12,000 people in more than 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on the Euronext Brussels Exchange. Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Georgia. For more information about UCB, visit www.ucb-group.com

Forward looking statement

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SOURCE UCB