Zonegran® Paediatric Pivotal Phase III Data Published in Epilepsia

      Zonegran® Paediatric Pivotal Phase III Data Published in Epilepsia

  PR Newswire

  HATFIELD, England, July 10, 2013

HATFIELD, England, July 10, 2013 /PRNewswire/ --

Results from a Phase III study of adjunctive Zonegran (zonisamide) in patients
aged 6-17 years with partial epilepsy is published today in leading clinical
and research epilepsy publication Epilepsia. ^[1] Zonisamide is a second
generation AED with multiple mechanisms of action and a chemical structure
which is unrelated to any other AEDs. ^[2] Once-daily Zonegran is currently
indicated as monotherapy in the treatment of partial seizures, with or without
secondary generalisation, in adults with newly diagnosed epilepsy and as
adjunctive therapy in the treatment of partial seizures (with or without
generalisation) in adults.

The estimated number of children and adolescents in Europe with active
epilepsy is 0.9 million. ^[ ^3] Only two thirds of children and young adults
with epilepsy will have seizure control once a suitable AED is found for them
and many children require additional AEDs (anti-epileptic drugs) to improve
seizure control. ^[ ^4] Epilepsy in children often presents major challenges
such as developmental and behavioural problems resulting in educational
underachievement and a lack of self-esteem. These issues, which are frequently
manifested in an attention deficit disorder, withdrawal, anxiety or
depression, have a negative impact on both the child and their family. ^[ ^5]

"Epilepsy has a high negative impact on both children and their families and
there is a pressing need for new treatment options as too many children still
experience breakthrough seizures," points out study author Professor Renzo
Guerrini from the Children's Hospital Anna Meyer-University of Florence,
Italy. "Some children may need to be on multiple medications and so it is
important to have a balance between stopping seizures and keeping treatment
related side effects to a minimum."

In the double-blind, placebo-controlled, multicentre trial (n=207), children
with partial epilepsy, receiving one or two antiepileptic drugs, were
randomised to receive either adjunctive once-daily zonisamide or placebo. The
primary efficacy end point of the study was the proportion of responders
(defined as a ≥50% seizure frequency reduction from baseline) during the
12-week maintenance period.

The responder rates were found to be 50% for zonisamide vs. 31% for placebo (p
= 0.0044). The overall incidence of treatment emergent adverse events (TEAEs)
was similar for zonisamide (55.1%) vs. placebo (50.0%), with low rates of
serious TEAEs in both arms of the study (3.7% zonisamide vs. 2.0% placebo) and
TEAEs leading to withdrawal (0.9% vs. 3.0%).

The continued development of zonisamide underscores Eisai's human health care
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 epilepsy and addressing the
unmet medical needs of patients with epilepsy and their families. Eisai is
proud to currently market more epilepsy products in EMEA than any other

About Zonegran (zonisamide)

Zonisamide is licensed in Europe as monotherapy in the treatment of partial
seizures, with or without secondary generalisation, in adults with newly
diagnosed epilepsy. In addition, zonisamide is also indicated as adjunctive
therapy in the treatment of partial seizures (with or without generalisation)
in adults with epilepsy. It has a broad spectrum of anti-epileptic modes of
action and has no appreciable effects on steady-state plasma concentrations of
other AEDs, such as phenytoin, carbamazepine and valproate. ^[ ^2 ^] Zonegran
is one of only four AEDs with level A efficacy/effectiveness evidence as
initial monotherapy for adults with partial onset seizures. ^[ ^6]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The
recommended daily dose for monotherapy use is 100mg once daily. In the third
and fourth weeks the dose may be increased to 200mg daily and then increased
to 300mg daily after the next two weeks.The recommended initial daily dose for
adjunctive use is 50mg in two divided doses. After one week the dose may be
increased to 100 mg daily and thereafter the dose may be increased at weekly
intervals, in increments of up to 100 mg. ^[ ^2 ^]

For more information please visit:

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world,
affecting approximately one in every one hundred people in Europe, and an
estimated 50 million people worldwide. ^[ ^7] ^, ^[ ^8] Epilepsy is a chronic
disorder of the brain that affects people of all ages. It is characterised by
abnormal discharges of neuronal activity causing seizures. Seizures can vary
in severity, from brief lapses of attention or jerking of muscles, to severe
and prolonged convulsions. Depending on the seizure type, seizures may be
limited to one part of the body, or may involve the whole body. Seizures can
also vary in frequency from less than one per year, to several per day.
Epilepsy has many possible causes but often the cause is unknown.

About Eisai EMEA in Epilepsy

Eisai is committed to developing and delivering highly beneficial new
treatments to help improve the lives of people with epilepsy. The development
of AEDs is a major strategic area for Eisai in Europe, the Middle East,
Africa, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  *Zonegran ^® (zonisamide) as monotherapy and adjunctive therapy in adult
    patients with partial-onset seizures, with or without secondary
    generalisation. (Zonegran is under license from the originator Dainippon
    Sumitomo Pharma).
  *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult
    patients with partial-onset seizures, with or without secondary
    generalisation. (Zebinix is under license from BIAL).
  *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures
    associated with Lennox-Gastaut Syndrome in patients >4 years (Rufinamide
    was originally developed by Novartis)
  *Fycompa ^® (perampanel) for use as an adjunctive treatment for partial
    onset seizures, with or without secondarily generalised seizures, in
    patients with epilepsy aged 12 years and older

About Eisai

Eisai is one of the world's leading research and development (R&D) based
pharmaceutical companies and we define our corporate mission as "giving first
thought to patients and their families and to increasing the benefits health
care provides," which we call human health care ( hhc ).

Eisai concentrates its R&D activities in three key areas:

  *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
  *Oncology including: anticancer therapies; tumour regression, tumour
    suppression, antibodies, etc
  *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid
    arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of
Japan, Eisai employs more than 10,000 people worldwide. From its Knowledge
Centre in Hatfield, UK, Eisai has recently expanded its business operations to
include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA
has sales and marketing operations in over 20 markets, including the United
Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria,
Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands,
Belgium, and the Middle East.

For further information please visit our web site


1. Guerrini R, Rosati A, Segieth J, Pellacani S, Bradshaw K, Giorgi l. A
randomized, phase III trial of adjunctive zonisamide in pediatric patients
with partial epilepsy. Epilepsia 2013

2. Eisai Ltd 2013. Zonegran Summary of Product Characteristics [ ]

3. Forsgren L. et al. The epidemiology of epilepsy in Europe - a systematic
review. European Journal of Neurology. 12(4) 245-253)


5. Sabbagh S, et al. Impact of epilepsy characteristics and behavioral
problems on school placement in children. Epilepsy & Behavior 9 (2006) 573-578

6. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug
efficacy and effectiveness as initial monotherapy for epileptic seizures and
[Accessed April 2013]

7. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. [Accessed 10
April 2012].

8. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224 - 2233.

Date of preparation: July 2013

Job code: Zonegran-UK2490

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155/ +44(0)7947-231-513,, ; Tonic Life Communications, Siobhan Reilly/Nicola
Lilley, +44(0)20-7798-9999 /+44(0)207-798-9905,,
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