Schwarz receives positive Phase III results
Germany's Schwarz Pharma, which is on the verge of merging with UCB of Belgium, has reported positive results from a Phase III trial of lacosamide in patients with painful diabetic neuropathy.
Germany's Schwarz Pharma, which is on the verge of merging with UCB of Belgium, has reported positive results from a Phase III trial of lacosamide in patients with painful diabetic neuropathy.
The company noted that data from the study showed statistically significant superiority for the drug versus a placebo in the primary variable and was also well tolerated.
106 patients with painful diabetic neuropathy were treated in the multi-centre, double-blind, placebo-controlled Phase III study and all of them began by receiving their optimal dose of lacosamide (<400mg/day). During 16 weeks treatment, lacosamide was withdrawn and re-introduced in a blinded fashion at pre-defined time points and overall, patients showed consistently higher average pain scores while taking placebo than when re-exposed to lacosamide.
The trial showed statistically significant superiority of lacosamide over placebo and no single side effect occurred in more than 10% of the patients, the most common being diarrhoea and nausea (both <5%).
Iris Loew-Friedrich, member of the executive board at Schwarz, said: "We are now preparing the application documents for a regulatory submission by the year end." Schwarz believes that lacosamide, which is also in Phase III trials for epilepsy, has great potential.