HATFIELD, England, October 22, 2014 /PRNewswire/ --
Zonegran® (zonisamide) continues to be well-tolerated
and efficacious when used as long-term monotherapy for the
treatment of partial onset seizures in adults with newly diagnosed
epilepsy, as demonstrated by a new publication in
Epilepsia.[1] Zonisamide is 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 secondary generalisation, in adults, adolescents,
and children aged six years and above.[2]
The extension study assesses zonisamide versus carbamazepine
monotherapy in patients from 72 sites in 17 countries in
Europe, Asia, Australia, and South
Africa, with over three-quarters exposed to over 24 months
of treatment. No other currently available anti-epileptic drug
(AED) has been studied in a double blind monotherapy setting over
such a long duration of
treatment.[1] Safety assessments
included treatment-emergent adverse events (TEAEs) and clinical
laboratory parameters. Efficacy assessments included retention rate
and the proportion of patients who remain seizure free for ≥24
months. Up to 81.6% of patients received the lowest target dose
levels (zonisamide 300 mg/day; carbamazepine 600
mg/day).[1]
"Monotherapy is the optimal treatment approach for newly
diagnosed epilepsy and zonisamide's proven long-term efficacy in
this setting is demonstrated by this study. This treatment, which
is easy to titrate and offers the advantage of once daily dosing,
may improve adherence to treatment for people with epilepsy,"
commented Professor Michel Baulac,
manuscript lead author and head of the clinical department at the
Hôpital de la Pitié-Salpêtrière, Paris,
France.
The international, multicenter, randomised, double-blind
extension of the Phase III non-inferiority trial (Study
310)[3] shows that once-daily zonisamide monotherapy
demonstrates favourable long-term safety and maintenance of
efficacy in the treatment of partial onset seizures in adults with
newly diagnosed epilepsy. Retention rates are similar between
treatment groups at all time-points throughout the extension study.
The proportion of patients who remain seizure free for ≥24 months
is also similar for zonisamide (32.3%) and carbamazepine (35.2%).
The incidence of treatment-related TEAEs is 26.3% for zonisamide
compared with 19.6% for carbamazepine and the most frequently
reported treatment-related TEAEs are decreased weight (5.1% vs.
0%), decreased appetite (3.6% vs. 0%), memory impairment (2.9% vs.
3.2%), and decreased hemoglobin (1.5% vs. 3.2%). Most TEAEs are of
mild or moderate intensity.[1]
Zonisamide has multiple mechanisms of action and a chemical
structure unrelated to any other
AED.[2] It is one of only four
AEDs with level A evidence of efficacy as initial monotherapy for
adults with partial onset seizures, as defined in the latest
International League Against Epilepsy (ILAE)
guidelines.[5]
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 to address 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.
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] Zonisamide is one of
only four AEDs with level A efficacy/effectiveness evidence as
initial monotherapy for adults with partial onset
seizures.[4]Worldwide there has been an estimated
1,274,963 patient-years of exposure to zonisamide (from
31.03.1989 to
31.03.2013).[5]
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.[6],[7]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 the development and delivery of 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
- Inovelon® (rufinamide) for the adjunctive treatment
of seizures associated with Lennox-Gastaut Syndrome in patients
>4 years. (Rufinamide was originally developed by Novartis)
- Zonegran® (zonisamide) 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, 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).
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 management
- 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, Iceland, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech
Republic, Slovakia,
the Netherlands, Belgium, Luxemburg, Russia and the Middle East.
For further information please visit our web site
http://www.eisai.co.uk
References
1. Baulac, M. et al. Long-term safety and efficacy of zonisamide
versus carbamazepine monotherapy for treatment of partial seizures
in adults with newly diagnosed epilepsy: Results of a phase III,
randomized, double-blind study. Epilepsia 2014;55:1534-1543
2. Zonegran, Summary of Product Characteristics (updated
October 2013):
http://www.medicines.org.uk/emc/medicine/16240/ (accessed
September 2014)
3. 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
4. Glauser T. et al. Updated ILAE evidence review of
antiepileptic drug efficacy and effectiveness as initial
monotherapy for epileptic seizures and syndromes. Epilepsia.
2013;54(3):551-63
5. Data on file: ZON2013-0003. Eisai Europe Ltd.
6. Epilepsy in the WHO European Region: Fostering Epilepsy Care
in Europe.
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
(Accessed July 2014)
7. Pugliatti M et al. Estimating the cost of epilepsy in
Europe: A review with economic
modeling. Epilepsia 2007:48(12):2224-2233.
Date of preparation: October
2014
Job code: Zonegran-UK2540