Preliminary results from a phase III withdrawal-design trial with lacosamide in patients with painful diabetic neuropathy show that lacosamide was statistically significant over placebo in reducing pain scores. SCHWARZ PHARMA plans for regulatory submission during the second half of 2007 SCHWARZ PHARMA announced last week that a phase III trial with lacosamide for the treatment of diabetic neuropathy showed statistically significant superiority versus placebo in the primary variable. Lacosamide was also well tolerated in this trial.
Iris Loew-Friedrich, MD, PhD, Member of the Executive Board SCHWARZ PHARMA AG said: “We see promising results underlining the efficacy and safety of lacosamide in neuropathic pain. We are now preparing the application documents for a regulatory submission by the year end."
106 patients with painful diabetic neuropathy were treated in this multi-center, double-blind, placebo-controlled phase III study. All patients began the trial receiving their optimal dose of lacosamide (< 400mg/day). During the 16 weeks treatment duration, lacosamide was withdrawn and re-introduced in a blinded fashion at pre-defined time points. Overall, patients showed consistently higher average pain scores while taking placebo than when re-exposed to lacosamide.
Treatment with lacosamide and placebo was compared in patients already receiving lacosamide in daily doses of up to 400mg/day in a long-term trial. The patients were entered in a sub trial and randomized to receive placebo treatment for up to 28 days at a pre-defined time point. Following the placebo period, patients were re-titrated to their previous optimal lacosamide dose in a double-blind fashion. The trial showed statistically significant superiority of lacosamide over placebo. The primary variable was change in average daily pain score from baseline to the end of each treatment period on lacosamide or placebo using an 11-point Likert pain scale. Lacosamide was very well tolerated in this trial. No withdrawal effects were observed when lacosamide was abruptly discontinued on entering the placebo period. No single side effect occurred in more than 10% of the patients, the most common side effects were diarrhea and nausea (both <5%).
SCHWARZ PHARMA has identified the novel dual mode of action for lacosamide: the selective enhancement of sodium channel slow inactivation and the modulation of CRMP-2 (collapsing response mediator protein 2). Preclinical trials showed that these novel modes of action could be the basis for the efficacy of lacosamide in the treatment of epilepsy and diabetic neuropathic pain. The mechanism might also interfere with the progression of the diseases. The mode of action data were initially presented at the 9th International Conference on the Mechanisms and Treatment of Neuropathic Pain, Bermudas, in November 2006.
SOURCE: SCHWARZ PHARMA
DID YOU KNOW:
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