Zonegran® (Zonisamide) Monotherapy Now Available in Russia for Adults With Newly Diagnosed Epilepsy

  Zonegran® (Zonisamide) Monotherapy Now Available in Russia for Adults With
                           Newly Diagnosed Epilepsy

  PR Newswire

  HATFIELD, England, April 28, 2014

HATFIELD, England, April 28, 2014 /PRNewswire/ --

Zonegran ^® (zonisamide) is now available in Russia as monotherapy in the
treatment of partial seizures, with or without secondary generalisation, in
adults with newly diagnosed epilepsy. ^[1] Once-daily zonisamide is a second
generation anti-epileptic drug (AED) with multiple mechanisms of action and a
chemical structure unrelated to any other AEDs. ^[ ^1 ^]

For people with newly diagnosed epilepsy, monotherapy is the preferred option
for managing their condition as the potential for adverse drug interactions is
reduced and treatment compliance is encouraged. ^[2]

"Monotherapy is the optimal treatment approach for newly diagnosed epilepsy
and zonisamide's proven efficacy in this setting will help people to control
their seizures," commented Professor Pavel Vlasov, Neurology and Neurosurgery
department at the Moscow State University of Medicine and
Stomatology."Zonisamide is a welcome new addition to our armamentarium in
Russia."

Epilepsy is one of the most common neurological conditions in the world. ^[3]
Around 3 out of every 1,000 people in Russia live with the condition, 82% of
which have partial epilepsy. ^[4] The successful treatment of partial onset
seizures (the most common type of epilepsy) remains a significant challenge
and up to 30% of patients fail to achieve seizure freedom with existing AEDs.
^[5]

The efficacy and safety of zonisamide as monotherapy has been demonstrated in
a double-blind, randomised, multicentre study of 583 newly diagnosed adult
partial epilepsy patients, which compared the efficacy and safety of
once-daily zonisamide with twice-daily controlled release carbamazepine as
monotherapy. The study's primary endpoint was the proportion of seizure-free
patients for 26 weeks or more. Zonisamidedemonstrated high seizure freedom
rates in newly diagnosed patients with epilepsy, ^[ ^6] similar to controlled
release carbamazepine. In the majority of patients, seizure freedom was
achieved at the target dose of 300 mg. Zonisamide was considered non-inferior
to carbamazepine andwas well tolerated after one year of treatment at doses
ranging from 300 to 500 mg/day.

"We are delighted to announce the launch of Zonegran in Russia." commended
Olga Konopleva, Managing Director, Eisai Russia. "Patients are our first
priority and we hope that the availability of Zonegran monotherapy provides
doctors with a new alternative treatment option that allows them to tailor
treatment to individual patient needs."

The continued development of zonisamide 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 epilepsy and addressing the
unmet medical needs of people with epilepsy and their families. Eisai is proud
to market currently more epilepsy products in EMEA than any other company.

                                 ***ENDS*** 

Notes to Editors 

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. Zonisamide is also indicated in Europe as adjunctive
therapy in the treatment of partial seizures, with or without secondary
generalisation, in adults, adolescents and children aged six years and above.
^[ ^1 ^] 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. ^[ ^1 ^] Zonegran is one of only
four AEDs with level A efficacy/effectiveness evidence as initial monotherapy
for adults with partial onset seizures. ^[7] ^ Worldwide there has been an
estimated 1,274,963 patient-years of exposure to Zonegran® (from 31.03.1989 to
31.03.2013). ^[8]

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. ^[ ^1 ^]

For further information please visit: http://www.zonegran.eu

About Epilepsy 

Epilepsy is one of the most common neurological conditions in the world,
affecting approximately eight in 1,000 people in Europe, and an estimated 50
million people worldwide. ^[9] ^, ^[10] 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:

  *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
  *Zonegran ^® (zonisamide) as monotherapy in adults 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, adolescents
    and children aged six years and above. (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)

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
    loss
  *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 EMEA
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, Russia and the Middle East.

For further information please visit our web site http://www.eisai.ru or
http://www.eisai.co.uk

References 

1. Eisai Ltd 2013. Zonegran summary of product characteristics (last updated
October 2013)
https://www.medicines.org.uk/emc/history/16240/SPC/Zonegran+25,+50,+100+mg+Hard+Capsules


2. St. Louis, K. Rosenfeld. W. Bramley, T. Antiepileptic Drug Monotherapy: The
Initial Approach in Epilepsy Management (2009) &(2): 77-72

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care
in Europe 2010. Available at;
http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf
(Accessed September 2013) 

4. Guekht A. et al. The epidemiology of epilepsy in the Russian Federation.
Epilepsy Res 2010; 92(2-3):209-18 

5. Kwan P, Brodie MJ Early identification of refractory epilepsy. New England
Journal of Medicine 2000; 342:314-9

6. Baulac, M. Efficacy and tolerability of zonisamide versus
controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase
3, randomised, double-blind, non-inferiority trial. Lancet Neurology (2012),
11 (7) 579 - 588

7. Glauser T. et al. Updated ILAE evidence review of antiepileptic drug
efficacy and effectiveness as initial monotherapy for epileptic seizures and
syndromes.

8. Data on file: ZON2013-0003. Eisai Europe Ltd.

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
September 2013].

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

Date of preparation: April 2014

Job code: Zonegran-UK2520

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155/+44(0)7947-231-513, Cressida_Robson@eisai.net,
Charlotte_Andrews@eisai.net. Tonic Life Communications, Frances Murphy/Nicola
Lilley , +44(0)207-798-9262 /+44-(0)207-798-9905, frances.murphy@toniclc.com,
nicola.lilley@toniclc.com
 
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