New Data for Fycompa® (perampanel) and Inovelon® (rufinamide) Further Validate Long-Term Seizure Control and Safety Prof

HATFIELD, England, September 8, 2016 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

Eisai present several abstracts on new data at 12th European Congress on Epileptology (ECE) for epilepsy treatments 

Data from several abstracts for Eisai's epilepsy treatments Fycompa(R) (perampanel) and Inovelon(R) (rufinamide) will be presented at the 12th European Congress on Epileptology (ECE), 11-15 September 2016, Prague, Czech Republic.  These new data augment previous evidence on the efficacy and safety for these agents in different epilepsy seizure types, including generalised tonic clonic seizures (primary and secondary), and Lennox-Gastaut Syndrome.

Perampanel is indicated in the European Union for the adjunctive treatment of partial-onset seizures, with or without secondary generalised seizures, and for primary generalised tonic clonic seizures, in patients with idiopathic generalised epilepsy (IGE) aged 12 years and older.[1] Rufinamide is indicated in the European Union as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut Syndrome in patients 4 years of age and older.[2]

"The data presented at ECE reinforce Eisai's continued focus on epilepsy treatment options that have the potential to improve outcomes in different patient populations. Epilepsy is a challenging condition to manage - those affected by it just want to get on with life through better seizure control and acceptable tolerability. Building the evidence for perampanel and rufinamide is therefore vital to enable clinicians to better understand and optimise treatment outcomes in clinical practice," comments Neil West, Vice President, Global Neurology Business Group, Eisai EMEA.

Data from several analyses will be presented for the 332 randomised, placebo-controlled, clinical trial[3] of adjunctive perampanel including an interventional open label extension study,[4] and post-hoc analyses of study 332[5] in myoclonic and absence seizures.

Abstract #0074 - Perucca E et al[6] - 12 September 11:30-13:00 

Adjunctive perampanel was associated with improved seizure control in patients with partial-onset seizures treated for up to four years (n=78) and particularly in subjects with secondary generalised seizures at baseline. No new safety signals were seen during long-term perampanel exposure.

Abstract #0073 - O'Brien T et al[5] - 14 September 11:30-13:00

Epilepsy drugs can paradoxically increase seizure activity, and most notably absence or myoclonic seizures.[7]   Outcomes in a post-hoc analysis of the 17-week core phase of study 332 showed that compared with placebo, adjunctive perampanel did not show clear evidence for worsening of myoclonic or absence seizures. However, the study was not powered to detect differences in these seizure types.

Abstract #P555 - Weschler R et al[4] - 14 September 13:00-14:30

In an interventional open label extension study,[4] 138 IGE patients with drug-resistant primary generalised tonic clonic seizures who received long-term adjunctive perampanel for up to 142 weeks (2.7 years), had a favourable risk-benefit ratio. Outcomes were consistent with the known safety profile for perampanel. A total 120 patients (87%) experienced treatment-emergent adverse events (AEs) including 20 (14.5%) with severe AEs, 18 (13%) with serious AEs, and 13 (9.4%) with AEs that lead to withdrawal.

Abstract #P590 - Auvin S et al[8]- 13 September 13:00-14:30 

Results from a recent European patient registry study[8] for safety in 111 patients of all ages (greater than or equal to4 years) with Lennox-Gastaut Syndrome suggest the potential for rufinamide and 'other' antiepileptic drugs in the long-term treatment of LGS. After 12 months, the proportion of patients rated as 'minimally', 'much', or 'very much' improved in control of all seizures was 47.6% (n=20/42) for rufinamide and 39.4% (n=13/33) for 'other' antiepileptic drugs. Treatment related adverse events were 40.6% for rufinamide and 27.7% for 'other' drugs.[8] The most frequently reported rufinamide-related adverse events (greater than or equal to5% patients) were somnolence (7.8%) and decreased appetite (6.3%).  

Abstract #P622 - Brandt C et al[9]- 14 September 13:00-14:30 

There are limited published data on the treatment of adults with Lennox-Gastaut Syndrome.  In analyses of a registry study,[8] data on adults (greater than or equal to18 years; n=24) were extracted and analysed.  At month 24, the proportion of patients rated as 'minimally', 'much', or 'very much' improved in control of all seizures was 71.4% (n=5/7) for rufinamide 50% (n=2/4) with 'other' antiepileptic drugs. Adverse events were seen in 50% of patients on rufinamide compared with 37.5% for 'other' drugs.[9]

Abstract Number
Timing of presentation Abstract details

Perampanel Marked Reduction in Secondarily Generalised Seizures
Abstract number: #0074 in Patients Treated With Perampanel for 3 and 4 Years
Platform Session 1 Emilio Perucca, Gregory L Krauss, Patrick Kwan,
Antiepileptic Drugs 1 Elinor Ben-Menachem, Xue-feng Wang, Jerry Shih,
Monday 12 September Betsy Williams, Antonio Laurenza, Haichen Yang
11.30 - 13.00
Congress Hall

Abstract number: #0073 Myoclonic and Absence Seizures in Patients With
Platform Session 13 Idiopathic Generalized Epilepsy (IGE): Exploratory
Antiepileptic Drugs 3 Outcomes in a Phase III PGTC Study With Adjunctive
Wednesday 14 September Perampanel
11.30 - 13.00 Terence J O'Brien, Bernhard J Steinhoff, Antonio
Forum Hall Laurenza, Anna Patten, Francesco Bibbiani, Haichen Yang

Abstract number: #P555 Long-term safety and efficacy of adjunctive
Poster Session perampanel in patients with drug-resistant primary
Pharmacology / AEDs 10 generalised tonic clonic seizures in idiopathic
Wednesday 14 September generalised epilepsy: results of an open-label extension
13.00 - 14.30 Robert T Wechsler, Jacqueline French, Eugen Trinka,
Poster Area (Forum Hall Christian Brandt, Terence O'Brien, Francesco
Foyer) Bibbiani, Anna Patten, Antonio Laurenza

Rufinamide
Abstract number: #P590 European non-interventional registry study of
Poster Session antiepileptic drug use in patients with
Pharmacology / AEDs 5 Lennox-Gastaut Syndrome
Tuesday 13th September Stéphane Auvin, Rob McMurray, Christian Brandt,
13.00 - 14.30 Marina Nikanorova
Poster Area (Forum Hall
Foyer)

Abstract number: #P622 Use of rufinamide and other antiepileptic drugs in
Poster Session the management of adult patients (greater than or
Pharmacology / AEDs 9 equal to18 years) with Lennox-Gastaut Syndrome
Wednesday 14 September Christian Brandt, Rob McMurray, Stéphane Auvin,
13.00 - 14.30 Marina Nikanorova
Poster Area (Forum Hall
Foyer)

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 

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