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Succesful Phase III studies with Fycompa (Eisai) for Epilepsy published in Epilepsia

Read time: 1 mins
Last updated:13th May 2013
Published:13th May 2013
Source: Pharmawand

Data from three pivotal Phase III clinical studies of Fycompa (perampanel), from Eisai, shows the drug reduced partial Epilepsy seizure frequency and improved responder rates compared to placebo. The pooled analysis of nearly 1,500 patients in Study 304, 306 and 307 showed that median reductions in partial seizure frequency were greater with perampanel 4 mg (-23�3%), 8 mg (-28�8%), and 12 mg (-27�2%) than placebo (-12�8%; p<0�01). fifty percent responder rates were greater with perampanel 4 mg (28�5%), 8 mg (35�3%), and 12 mg (35�0%) than placebo (19�3%; p><0�05).>

Median reductions in complex partial seizure frequency were also greater with perampanel. It was generally well tolerated with most adverse events being mild or moderate. Data has been published in Epilepsia: "Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: a pooled analysis of three Phase III studies." Steinhoff B et al. Epilepsia 10 May 2013.

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