SCHWARZ ANNOUNCES RESULTS FROM NEUROPATHIC PAIN TRIAL
Schwarz Pharma announced that a Phase III trial of lacosamide for the treatment of diabetic neuropathy showed statistically significant superiority versus placebo in the primary endpoint. The company plans to submit a regulatory application for the drug by the end of the year.
A total of 106 patients with painful diabetic neuropathy were treated in this multicenter, double-blind, placebo-controlled study. All patients began the trial receiving an optimal dose of lacosamide of less than 400 mg per day. During the 16-week treatment duration, lacosamide was withdrawn and re-introduced in a blinded fashion at predefined time points.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 400 mg per day in a long-term trial. The patients were entered in a subtrial and randomized to receive placebo treatment for up to 28 days at a predefined 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 endpoint 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, and no withdrawal effects were observed when lacosamide was abruptly discontinued.
The company has identified the novel dual mode of action for lacosamide as the selective enhancement of sodium channel slow inactivation and the modulation of collapsing response mediator protein 2. Preclinical trials showed that these 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.