New data provides additional evidence for use of Fycompa in partial-onset epilepsy
HATFIELD, England, June 26, 2013 /CNW/ - 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 (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 ( 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.
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New Fycompa® (perampanel) Data Presented at International Epilepsy Congress (IEC)