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 placebo in the primary variable and was also well tolerated.
106 patients with painful diabetic neuropathy were treated in this 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 During 16 weeks treatment, lacosamide was withdrawn and re-introduced in a blinded fashion at pre-defined time points and overall, patients showed consistently higher average pain scores while taking placebo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.
Treatment with lacosamide and placebo was compared in patients already receiving the latter in daily doses of up to 400mg/day in a long-term trial. They were then entered in a sub-trial and randomised to receive placebo treatment for up to 28 days at a pre-defined time point and 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 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, welcome news for UCB as it is facing the loss of patent protection on key products such as the antihistamine Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam).