New Fycompa® (Perampanel) Data Presented At International Epilepsy Congress (IEC)

Date: Jun-28-2013New data provides additional evidence for use of Fycompa in partial-onset epilepsy

New data from 11 abstracts, including two oral presentations, presented at the 30th
International Epilepsy Congress (IEC) in Montreal, Canada provide additional data on the
safety, efficacy and impact on quality of life (QOL) of once daily Fycompa(R) (perampanel)
as adjunct treatment in partial-onset epilepsy, the most common form of seizures.

One oral presentation highlighted the low discontinuation rates seen with long term
perampanel treatment amongst patients who could titrate to higher doses, and a second oral
presentation showed that the reduction in seizures achieved with perampanel leads to
significantly improved patient QOL, even after adjusting for treatment related side
effects.[1],[2]

The first oral presentation examined the long term retention rates and the reasons for
discontinuation of treatment in over 1000 patients from Phase III trials who received
adjunctive perampanel treatment for 24 weeks.[1]The results showed that the total
discontinuation rates declined over time, from 7.9 % at 24-36 weeks to 2.0% at 72 weeks
and this was mirrored by a decline in rates of discontinuation due to adverse events (AEs)
from 2.6% at 24-36 weeks to 0.8% at 72 weeks. In the patients that discontinued treatment
after 24 weeks, the most common reasons were patient choice, inadequate therapeutic
effects and AEs. The investigators concluded that the pattern of discontinuation showed
that patients who could titrate to higher doses tended to stay on those doses, whereas
intolerant patients tended to discontinue earlier and at a lower dose.

In the second oral presentation, Phase III data from nearly 1000 patients with
refractory partial epilepsy was assessed to determine the effect of seizure reduction and
treatment related AEs on overall QOL.[2] The Quality of Life in Epilepsy (QOLIE)
instrument was used to show changes in quality of life over time. The results showed that
reductions in seizures significantly improve QOL and decrease distress in epilepsy
patients even after adjusting for side effects.

Study 307 - 10 months additional data from open-label extension study

Also presented at the IEC were additional 10 months safety and efficacy data from
study 307, an open label extension sub-group study for subjects who had completed either
one of the previous three double-blind Phase III clinical trials of perampanel in
refractory partial-onset seizures in patients aged 12 and above.[3],[4]

Seizure outcomes in 1090 patients in 13 week intervals in four subsets of patients (
greater than or equal to 6, 9, 12 and 24 months of perampanel treatment) were assessed.[3]

Most of the seizure improvement with perampanel occurred in the first 26 weeks of
treatment, as the drug was up-titrated. The responder rate (RR) was 32-35% at week 1-13
and 42-48% at weeks 14-26. Thereafter, the seizure outcomes were stable: RR ranged from
52% at week 27-39 to 58% at weeks 92-104. The patterns were similar in secondarily
generalised seizures and the investigators concluded that seizure outcomes with adjunctive
perampanel are stable over time up to two years of treatment.

Safety data from study 307[4] extended the published long-term safety / tolerability
data[5] with an additional 10 months open label extension. No new safety signals were
identified in this extension study which included an analysis of 7260 additional
patient-months of treatment.

"Study 307 is a large, long term treatment trial enrolling patients from three pivotal
trials and provides important long term safety and efficacy data," said Dr. Gregory
Krauss, Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.

Perampanel efficacy and age

A further post-hoc study presented at IEC looked to see whether the age at the time of
epilepsy diagnosis had any effect on perampanel efficacy as the risks of developing
unprovoked seizures differs in childhood compared to later life.[6] A pooled analysis of
perampanel Phase III trials was carried out involving data from nearly 1500 patients aged
12 and above. The results showed that, despite differences in the baseline characteristics
of patients, daily perampanel 4-12 mg demonstrated efficacy that was not related to age.

"The new data presented at IEC will further educate physicians on the efficacy and
safety data from the drug's clinical development programme, and assist them in making
treatment decisions for their refractory partial-onset seizure patients", pointed out
David Squillacote, Eisai Global Medical Affairs, Woodcliff Lake, US."

Discovered and developed by Eisai, 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.[7] 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,[8] and it is the only third generation
epilepsy treatment approved for adolescents from launch which can lead to earlier seizure
control in younger patients.
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.