German drugmaker Schwarz Pharma presented positive Phase III safety and efficacy trial data on oral lacosamide as adjunctive therapy in adults with uncontrolled partial seizures at the North American Regional Epilepsy Congress, held in San Diego, California. Both lacosamide 200mg/day and 400mg/day demonstrated statistically-significant and clinically-relevant improvements over placebo and were generally well-tolerated when administered concomitantly to patients previously uncontrolled on up to three different anti-epileptic drugs, the firm noted.
In this multicenter, double-blind, placebo-controlled trial, reduction in seizure frequency over placebo was 14.4% (p=0.02) for the lacosamide 200mg/day group and 15.0% (p=0.03) for those on 400mg/day. Schwarz also noted that the 50% responder rate for the later group was 40.5% versus 25.8% for placebo (p=0.006), adding that the agent was generally well-tolerated.
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