New Results For Fycompa(R) (Perampanel) Presented At Leading Epilepsy Conference

Date: Oct-09-2012New data shared with Europe's epilepsy community at the 10th European Congress
on Epileptology (ECE) in London, demonstrate the efficacy of once-daily Fycompa(R)
(perampanel) in reducing partial-onset seizures, the most common form of epilepsy, and its
effectiveness and flexibility of use as add-on therapy.

The successful treatment of partial-onset seizures (the most common form of epilepsy)
remains a significant challenge in some patients and the incidence of uncontrolled partial
epilepsy remains high, despite many existing anti-epileptic drugs (AEDs); between 20 - 40%
of patients with epilepsy have remained poorly controlled despite these treatments.[1] The
new data supports the use of perampanel as a new therapeutic option for this hard-to-treat
patient population.

Results from two separate analyses of pooled data from the perampanel pivotal Phase
III clinical trial programme endorse the efficacy and safety of the new AED at clinically
relevant doses.[2] In addition, the results show that perampanel decreased the frequency
of both complex partial seizures and secondarily generalised seizures.[3] In a third
analysis of the pooled trial data, patients with uncontrolled partial-onset seizures
taking any of the five most commonly-used AEDs with perampanel as an add-on therapy
experienced a reduction in their seizure frequency. Patients generally received additional
benefit from increased doses of perampanel.[4]

"This first-ever presentation of the pooled data from the perampanel Phase III trial
programme has been anticipated by the epilepsy community. These results complement to the
wealth of efficacy and safety data from the clinical development programme supporting the
use of the new treatment. In addition, they further demonstrate the important adjunctive
role that perampanel may have in the treatment of patients with partial onset seizures in
Europe," commented Professor Bernhard Steinhoff Medical Director and Executive at the
Epilepsy Centre, Kehl-Kork, Germany.

Specific results from the three new analyses include:
Abstract 656; E. Ben-Menachem et al.:[2] 1,265 patients (348, 161, 159,
     46, 287, 14, 114) patients were included in the safety population for placebo,
     perampanel 2, 4, 8, 12 mg (randomized dose). Median percent changes in seizure
     frequency for placebo, 2, 4, 8, 12 mg were -11.7%, -17.3%, -24.1%, -31.9%, -26.2%,
     respectively. Responder rates were 18.4%, 22.4%, 30.8%, 37.6%, and 39.5%. These data
     are comparable with randomized results from the individual studies, which did not
     account for failure to reach assigned doses. Safety analyses were also comparable.

Abstract 417; B.J. Steinhoff et al.:[3] 442, 180, 172, 431, and 254 patients
     were randomised to placebo, perampanel 2, 4, 8, 12 mg, respectively. Median percent
     changes in CPS+SGS frequency were -14.6% (n=319), -26.6% (n=150), -35.6% (n=145),
     -35.9% (n=267), -30.3% (n=104) for placebo, perampanel 2, 4, 8, 12 mg actual doses.
     Responder rates were 21.9%, 29.3%, 37.9%, 40.1%, 39.4%. Median percent changes in SGS
     frequency were -19.5% (n=133), -27.9% (n=60), -54.6% (n=66), -60.8% (n=112), -56.0%
     (n=43) for placebo, 2, 4, 8, 12 mg. Responder rates were 38.3%, 43.3%, 53.0%, 56.3%,
     53.5%

Abstract 669; E. Trinka et al.:[4] Median changes from baseline in seizure
     frequency for the five most common concomitant AEDs in the pooled perampanel Phase III
     studies are provided for placebo, 4, 8, 12 mg, respectively. Carbamazepine: -13%
     (n=128), -24% (n=49), -30% (n=116), -18% (n=65); valproate: -18% (n=128), -28% (n=69),
     -31% (n=94), -26% (n=31); lamotrigine: -13% (n=112), -25% (n=64), -33% (n=113), -37%
     (n=36); levetiracetam: -18% (n=116), -19% (n=46), -31% (n=92), -39% (n=46);
     oxcarbazepine: -5% (n=80), -36% (n=24), -32% (n=54), -38% (n=21). 50% responder rates
     for each of the AEDs were generally consistent with the median percent changes.
Discovered and developed by Eisai in Europe and Japan, perampanel is the first and
only licensed AED in Europe with a mode of action that selectively targets AMPA receptors,
which are thought to play a central role in seizure generation and spread.[5] This first
in class treatment selectively targets the transmission of seizures by blocking the
effects of glutamate, which can trigger and maintain seizures. In addition, perampanel has
the added benefit of convenient, once-daily dosing taken at bedtime,[6] and it is the only
contemporary epilepsy treatment approved for adolescents from launch which can lead to
earlier seizure control in younger patients.

The European Commission's (EC) Marketing Authorisation Approval of perampanel was
based on three global pivotal Phase III studies with 1,480 subjects. These randomised,
double-blind, placebo-controlled, and dose-escalated studies showed consistent results in
the efficacyand tolerability of perampanel as an adjunctive therapy in patients with
partial-onset seizures (with or without secondary generalisations).[7],[8],[9] The most
commonly reported adverse events were dizziness, headache, somnolence, irritability,
fatigue, falls, and ataxia.[7],[8],[9]

The development of perampanel underscores Eisai's human health care mission, the
company's commitment to innovative solutions in disease prevention, cure and care for the
health and well being of people worldwide. Eisai is committed to the therapeutic area of
epilepsy and addressing the unmet medical needs of patients and their families.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.