Epilepsy Monotherapy Zonegran(R) (Zonisamide) Supported By Phase III Data

Date: Jun-29-2012New monotherapy options are needed as up to a third of epilepsy patients remain uncontrolled[1]

Leading international journal, The Lancet Neurology, today published positive results
from a new pivotal Phase III Zonegran(R) (zonisamide) monotherapy study showing that
once-daily zonisamide is non-inferior to controlled-release carbamazepine (Tegretol(R)
retard) and could prove to be a useful initial monotherapy for newly diagnosed partial
onset epilepsy patients[2] Carbamazepine is the most well-established monotherapy
comparator for patients newly diagnosed with partial onset seizures (the most common type
of epilepsy).[2]

Commenting on the results, Professor Michel Baulac, manuscript lead author and head of
the clinical department at the Hospital de la Pitie-Salpetriere, Paris, France said;
"These data will be of key interest to general neurologists and epileptologists across
Europe as they demonstrate that zonisamide is effective and non-inferior to the standard
first line monotherapy. It is essential to ensure newly diagnosed epilepsy patients
achieve adequate seizure control, so a potential new and effective monotherapy treatment
option is very exciting."

The double-blind, randomised, multicentre study of 583 adult patients with newly
diagnosed partial epilepsy (282 zonisamide, 301 carbamazepine)[2], set out to compare the
efficacy and safety of once-daily zonisamide with twice-daily controlled release
carbamazepine as a monotherapy for these patients. 456 patients were analysed for the
primary end point (per protocol population) and the results show that 79.4% (177 of 223)
patients in the zonisamide group and 83.7% (195 of 233) patients in the carbamazepine
group were seizure-free for 26 weeks or more (adjusted absolute treatment difference
-4.5%, 95% CI -12.2 to 3.1).[2] The statistical comparison between zonisamide and
carbamazepine met the criterion of non-inferiority (relative difference) as recommended by
treatment guidelines set out by the International League Against Epilepsy (ILAE).

The incidence of treatment-emergent adverse events in the study was comparable between
the zonisamide and carbamazepine groups.[2] The most frequently reported
treatment-emergent adverse events (greater than or equal to5% patients in either group)
were headache, decreased appetite, somnolence, dizziness and weight loss.[2] There were no
new or unexpected safety findings in the trial.[2]

Zonisamide is currently indicated as adjunctive therapy in the treatment of adult
patients with partial seizures, with or without secondary generalisation. The European
Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recently
issued a positive opinion for extending the use of once-daily zonisamide as monotherapy
for the treatment of partial seizures (with or without secondary generalisation) in adults
with newly diagnosed epilepsy. EU approval of the monotherapy indication is anticipated
within three months.

Dr Bettina Bauer, Head of EMEA Epilepsy Business Unit, Eisai Europe said; "There is a
need for new monotherapy options to allow physicians the ability to offer newly diagnosed
epilepsy patients with a wider choice of first-line treatment. These study results,
coupled with the CHMP's recent positive recommendation for monotherapy licence, suggest
the important new role that this established therapy may soon play in improving seizure
control in newly diagnosed epilepsy patients across Europe."

Zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms
of action and a chemical structure unrelated to other AEDs which means it is unlikely to
interact with other drugs.[3] Importantly, it has pharmacokinetic properties allowing for
the clinical advantage of once-daily dosing. For patients with newly diagnosed partial
onset epilepsy, monotherapy is the preferred option for managing their condition as this
reduces the potential for adverse drug interactions.[4]

The continued investment in 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 and their families.

About Zonegran (zonisamide)

Zonisamide is licensed in Europe 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.[3]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. 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.[3]
About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting
approximately eight in 1,000 people in Europe.[5] There are an estimated six million
people living with epilepsy in Europe[6]and an estimated 50 million people with the
condition worldwide[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.

View drug information on Zonegran.
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.