Schwarz reveals phase III trial results

Schwarz Pharma has said that the phase III trial of oral lacosamide at significant levels as a treatment for diabetic neuropathic pain has yielded some important results.

The company has said that the target dose of oral lacosamide, which is 400mg/day, showed a “clinically relevant” level of reduction in diabetic neuropathic pain, according to the trial results.

“Based on the convincing entirety of results from the clinical development programme we plan to discuss with the authorities filing for lacosamide in diabetic neuropathic pain,” said Dr Iris Loew-Friedrich, member of the executive board at Schwarz Pharma.

“At our target dose, lacosamide had a clinically relevant effect in neuropathic pain.”

The phase II and phase III clinical trials of oral lacosamide conducted by Schwarz Pharma evaluated the effect of the treatment on more than 1,500 patients. The company also has further trials that are continuing.

Phase III trialling of the treatment compared groups taking either placebo, 200mg/per day, 400mg/day or 600mg/day of oral lacosamide over a period lasting no more than 18 weeks.

Patients taking part in the trial used an electronic system to rate their pain on a scale of one to ten twice daily.

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