HATFIELD, England, September 13, 2016 /PRNewswire/ --
FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/CZECH REPUBLIC JOURNALISTS
New data presented from registry study for Inovelon(R) (rufinamide) for people with
Lennox-Gastaut Syndrome
New data presented today at the 12th European Congress on Epileptology (ECE) of an open-label extension study of the pivotal Phase III randomised, double-blind, placebo-controlled, clinical Study 332, showed that long-term adjunctive perampanel for up to two and a half years (142 weeks) provided sustained seizure control and was generally well tolerated in poorly controlled patients with primary generalised tonic clonic (PGTC) seizures, in idiopathic generalised epilepsy (IGE).[1]
Perampanel is indicated in the European Union for adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, and for adjunctive treatment of PGTC seizures in patients with IGE aged 12 years and older.[2]
In the open-label extension study, 138 patients received once-daily adjunctive perampanel for up to 136 weeks following dose-optimisation in a 6-week blinded conversion period. Sixty patients discontinued perampanel during the extension study, most (n=41) due to reasons other than adverse events or inadequate therapeutic response. By the end of the conversion period, results were as follows:[1]
Seizure Measure N=138
Perampanel (n=68) Placebo (n=70)
Median per cent change
in PGTC seizure
frequency -93.1% -100%
50% responder rates 75.0% 74.3%
Treatment-emergent adverse events were seen in 120 patients (87.0%) with 20 patients (14.5%) having severe adverse events, 13 Sep. (13.0%) - with serious adverse events, and 13 (9.4%) with adverse events leading to withdrawal.[1]
"The extension study shows that patients with primary generalised tonic clonic seizures in idiopathic generalised epilepsy achieve similar clinical benefits, with consistent tolerability, to those seen previously in Study 332," comments Eugen Trinka, Professor and Chair of the Department of Neurology, Paracelsus Medical University, Salzburg, Austria.
Exploratory outcomes from a post-hoc analysis of the 17-week core phase of Study 332 showed that compared with placebo, adjunctive perampanel showed no clear evidence for worsening of myoclonic or absence seizures.[3] There was a difference in baseline seizure frequency for myoclonic and absence seizures between perampanel and placebo groups and the study was not powered to detect differences in these seizure types.
(n=162)
Seizure Type Perampanel (n=81) Placebo (n=81)
Baseline myoclonic 29.0%
Baseline absence 37.0%
Perampanel Placebo
Absence seizure freedom 22.2% 12.1%
Absence seizure worsening 29.6% 45.5%
Myoclonic seizure freedom 16.7% 13.0%
Myoclonic seizure worsening 29.2% 30.4%
The most common adverse events with perampanel in the 17-week core phase of Study 332 were dizziness, fatigue, headache, somnolence and irritability.[4]
Data from open-label extension Study 307 in patients with focal epilepsy treated with adjunctive perampanel for up to four years were also presented, including seizure outcomes:[5]
Change during last year of 3 Years Perampanel 4 Years Perampanel
perampanel treatment Exposure (n=436) Exposure (n=78)
Median % seizure reduction 61.98% 70.63%
Median % seizure reduction
in secondarily generalised
seizures 87.96% 100%
50% responder rate 59.6% 67.9%
No new safety signals were seen during long-term perampanel
exposure
Final results from a European patient registry study[6] for safety in 111 patients of all ages (greater than or equal to4 years) with Lennox-Gastaut Syndrome (LGS), suggest the potential for rufinamide and 'other' antiepileptic drugs in the long-term treatment of LGS. At Month 12, the proportion of patients rated as 'much', or 'very much' improved in control of all seizures was 12/42 (28.6%) and 5/33 (15.2%) for rufinamide and other AEDs, respectively.
Treatment-related adverse events were reported for 40.6% for rufinamide and 27.7% for other AEDs patients, and led to discontinuation of 7.8% and 2.1% of patients, respectively. The most frequently reported rufinamide-related adverse events (greater than or equal to5% patients) were somnolence (7.8%) and decreased appetite (6.3%). There were no unexpected safety findings.
Rufinamide is indicated in the European Union as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut Syndrome in patients four years of age and older.[7]
There are limited published data on the treatment of adults with Lennox-Gastaut Syndrome. In another analysis of this study,[8] data on adults (greater than or equal to18 years) were extracted and analysed. Twenty-four adult patients were included (16 on rufinamide and 8 on another antiepileptic drug).
At Month 24, the proportion of patients rated as 'much' or 'very much' improved in control of all seizures was 2/7 (28.6%) and 2/4 (50.0%) for rufinamide and other AEDs, respectively. AED-related adverse events were reported for 50.0% for rufinamide and 37.5% for other AEDs patients, and led to discontinuation of 6.3% and 0% of patients, respectively. The only rufinamide-related adverse event reported for more than one adult was somnolence (n=2). There were no unexpected safety findings.
The registry enrolled patients with Lennox-Gastaut Syndrome (age greater than or equal to4 years) requiring modification to any anti-epileptic treatment, including initiation of rufinamide. The primary objective of the registry was to evaluate long-term safety.[6],[8] Seizure control was also assessed using a 7-point generic seizure frequency scale (rated from 'very much worse' to 'very much improved'). A total of 111 patients were enrolled and included in the safety analysis set, of whom 64 initiated rufinamide and 47 were initially allocated other antiepileptic drugs. For the analysis of the adult population from this safety analysis set, 24 patients were included (16 on rufinamide and 8 on another antiepileptic drug).[8]
"The data presented for perampanel and rufinamide provide new insights into the long-term care of people with epilepsy. There is no known cure and people have to live with the consequence of epilepsy day in and day out. Eisai is committed to understanding the long-term impact of its treatments, for seizure freedom and safety, and these results help us to enhance our knowledge of treatment in everyday life," comments Neil West, Vice President, Global Neurology Business Group, Eisai EMEA.
The continued development of its epilepsy portfolio underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of neurology and to address the unmet medical needs of people with epilepsy and their families.
Notes to Editors
About Fycompa(R) (perampanel)
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