HATFIELD, England, August 22, 2012 /PRNewswire/ --
Results of longer term safety and efficacy study also released
Results from the final pivotal Phase III study and long term Phase III extension study Fycompa(R) (perampanel), were published online today in Epilepsia(R). Findings from Study 305, one of three pivotal global studies, and the extension study for perampanel add further weight to the growing body of clinical evidence supporting the efficacy and safety of the new treatment.[1,2]
Perampanel is the only licensed anti-epileptic drug in Europe that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread.[3] This first in class treatment selectively targets the transmission of seizures by blocking the effects of glutamate, which can trigger and maintain seizures.
The 305 study demonstrated that once-daily, adjunctive perampanel improved seizure control and was acceptably-tolerated in subjects 12 years and older with refractory partial-onset seizures. Study 305 is one of three pivotal Phase III studies in the EXPLORE (EXamining PerampaneL Observations from Research Experience) clinical trial programme.[1]
Showing consistency with other results from the Phase III clinical trial programmes, the 307 interim results showed that perampanel had an acceptable tolerability profile in patients with refractory partial-onset seizures over the longer term. Furthermore, reduced seizure frequency and improved responder rates were consistent and maintained during 1 - 2 years of continued perampanel therapy.[2] Study 307 is an open-label extension study for people with epilepsy completing the double-blind phase of three pivotal Phase III trials (studies 304, 305, and 306).
"The publication of these encouraging new data comes at an important time for perampanel. They follow the publication of pivotal data from the therapys clinical development programme published in this months Neurology journal, and its European Commission approval on 23 July 2012, " noted Dr Antonio Laurenza, Executive Director and Head of Epilepsy, Neuroscience Product Creation Unit, Eisai. "In combination these results reinforce perampanels tolerability profile and demonstrate seizure control over the longer term."
Study 305
In the 305 study 386 patients were randomised and treated with study medication. Of these, 321 patients completed the study. The 50% responder rates (intent-to-treat analysis) were 14.7%, 33.3% (p = 0.002), and 33.9% (p < 0.001) respectively, for placebo, perampanel 8mg, and perampanel 12mg, with significant improvements over placebo for both perampanel 8mg and 12mg The median percent change from baseline in seizure frequency/28 days (intent-to-treat [ITT] analysis) was -9.7%, -30.5%, and -17.6% for placebo, 8mg (p < 0.001), and 12mg (p = 0.011), respectively, with significant reductions compared with placebo for both 8mg and 12mg. For complex partial seizures plus partial seizures that secondarily generalised, the median percent change in frequency was -32.7% (8mg), -21.9 (12mg), and -8.1% (placebo), with significant reductions for both 8mg (p < 0.001) and 12mg (p = 0.005). The most frequent (occurring in greater than or equal to10% of patients in any treatment group) treatment-emergent adverse events (AEs) were dizziness, somnolence, fatigue, and headache, with an apparent dose effect suggested for all except headache.[1]
Study 307
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Final Pivotal Phase III Fycompa® (perampanel) Study Results Published Ahead of First European Launch