Schwarz Pharma announces positive lacosmide trial results

Schwarz Pharma has announced the preliminary results of a phase III clinical trial of lacosamide in patients with diabetic neuropathy. The withdrawal-design trial showed a significant reduction in pain scores following administration of the compound.

The compound was also reported to be well tolerated in the 106 patients involved in the 16-week study. During the trial the compound was withdrawn and re-introduced to patients at blinded but pre-arranged times, with patients showing higher pain scores when on placebo.

Neuropathic pain, such as that experienced by patients with diabetic neuropathy, is a result of a functional disorder of the central or peripheral nervous system and does not serve as a warning function for the body.

Iris Loew-Friedrich, a member of the executive board of Schwarz Pharma, said: “We see promising results underlining the efficacy and safety of lacosamide in neuropathic pain.”

She added that the firm was preparing application documents for submission to the relevant regulatory bodies by the end of 2007.

Last November, Schwarz Pharma reported that two novel and distinct modes of action for lacosamide had been identified following preclinical studies.

These modes, the modulation of collapsing-response mediator protein-2 and the selective enhancement of sodium channel slow inactivation, are thought to be the basis of the efficacy of the compound in the treatment of diabetic neuropathic pain and epilepsy, while also having disease-modifying effects.