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New Fycompa« (Perampanel) Data Presented At International Epilepsy Congress (IEC)07/02/2013
New 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.,
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.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. 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.,
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.
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 extended the published long-term safety / tolerability data 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. 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. 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, and it is the only third generation epilepsy treatment approved for adolescents from launch which can lead to earlier seizure control in younger patients.
1. Zhu J et al. Long-term discontinuation rates in an extension study of the AMPA receptor antagonist perampanel as an adjunctive treatment for refractory partial seizures IEC abstract # 1037
2. Simons WR, Gilliam F. Effects of Treatment Response and Side Effects on overall Quality of Life and Distress. IEC abstract # 627
3. Ben-Menachem et al. Long-term seizure outcomes with perampanel in refractory partial-onset seizures and secondarily generalized partial seizures: 10-months additional data from extension study 307 following Phase III clinical trials. IEC abstract # 1330
4. Clément J-F et al. Long-term safety of perampanel: Additional 10 months of data from study 307, an extension of three randomized, placebo-controlled, double-blind, Phase III trials of perampanel in partial-onset seizures in patients aged 12 years and above. IEC abstract # 1161
5. Krauss GL et al. Epilepsia, ePub August 2012
6. Squillacote D et al. Adjunctive once-daily perampanel reduces seizure frequency and improves responder rates in patients with uncontrolled partial-onset seizures, irrespective of age at epilepsy diagnosis: a pooled analysis of three Phase III trials. IEC abstract #1036
7. Rogawski MA. Epilepsy Currents 2011;11:56-63
8. Fycompa Summary of Product Characteristics. 2012
9. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf ] [Accessed 10 April 2012].
10. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224 - 2233.
Source: Eisai Europe Limited
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