Inovelon® (rufinamide) Oral Suspension Formulation Launched in Spain

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Inovelon® (rufinamide) Oral Suspension Formulation Launched in Spain PR Newswire HATFIELD, England, January 2, 2013 HATFIELD, England, January 2, 2013 /PRNewswire/ -- Child friendly formulation set to aid administration for the treatment of Lennox-Gastaut syndrome ®Inovelon (rufinamide) oral suspension for adjunctive (add-on) treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older is launched today in Spain. As many patients who receive the orphan drug rufinamide are children, the new formulation has been developed as a child friendly drinkable liquid to aid the administration of treatment. "As some children find tablets difficult to swallow, there is a strong need for drinkable medicines especially when treating younger LGS patients. In addition, the use of the rufinamide oral suspension allows for individual titration in smaller steps to find the optimal dose for each patient", said Dr. Juan Jose Garcia Peñas, Neuropediatrician at the Hospital Infantil Universitario Niño Jesus. "The availability of the suspension formulation of rufinamide will potentially help young patients adhere better to treatment which should help improve outcomes in the management of this severe and highly debilitating disease." LGS is a rare form of epilepsy accounting for five percent of all cases and [1]rising to approximately 10 percent of childhood epilepsy cases. The annual incidence of the condition affects about 2.8 per 10,000 births in [1]Europe.

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• Publié par: eisai-europe-limited
• Nombre de lectures: 62
• Langue: English

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Inovelon® (rufinamide) Oral Suspension Formulation Launched in Spain

PR Newswire

HATFIELD, England, January 2, 2013

HATFIELD, England,January 2, 2013/PRNewswire/ --

Child friendly formulation set to aid administration for the treatment of

Lennox-Gastaut syndrome

® Inovelon (rufinamide) oral suspension for adjunctive (add-on) treatment of

seizures associated with Lennox-Gastaut syndrome (LGS) in children four

years and older is launched today in Spain. As many patients who receive

the orphan drug rufinamide are children, the new formulation has been developed as a child friendly drinkable liquid to aid the administration of treatment.

"As some children find tablets difficult to swallow, there is a strong need for

drinkable medicines especially when treating younger LGS patients. In

addition, the use of the rufinamide oral suspension allows for individual

titration in smaller steps to find the optimal dose for each patient", said Dr.

Juan Jose Garcia Peñas, Neuropediatrician at the Hospital Infantil

Universitario Niño Jesus. "The availability of the suspension formulation of

rufinamide will potentially help young patients adhere better to treatment

which should help improve outcomes in the management of this severe and

highly debilitating disease."

LGS is a rare form of epilepsy accounting for five percent of all cases and

[1] rising to approximately 10 percent of childhood epilepsy cases. The annual

[1] incidence of the condition affects about 2.8 per 10,000 births in Europe.

Effective LGS management and compliance to treatment is of key

importance to children as the condition is characterised by multiple daily

[2] seizures, mental retardation and regression.

"The launch of the new drinkable form of rufinamide in Spain will help address the needs of children and young people with this severe form of epilepsy. Improving treatment compliance is a key factor in helping to reduce

seizure frequencies, particularly for young people", said Antonio Rodriguez

Gallego, Brand Manager EPBU, Eisai Farmaceutica, S.A. "Eisai is working

closely with epilepsy centres in Spain to ensure the new treatment is

available to patients as soon as possible. This move is entirely in line with

our on-going commitment to the therapeutic area of epilepsy and our drive to

increase the benefits provided to patients and their families of our medicines

through Eisai'shuman health care (hhc) mission."

The oral suspension is identical in preparation to the currently marketed

rufinamide tablet on a milligram per milligram basis. Rufinamide oral

suspension received positive CHMP opinion inSeptember 2011and formal

EMA approval was granted inNovember 2011. The preparation was

approved by the FDA and launched in the US inMarch 2011(rufinamide is

® marketed as BANZEL in the US).

The development of an oral drinkable suspension formulation of rufinamide

demonstrates Eisai's commitment in the therapeutic area of epilepsy and

further exemplifies the company's contribution to addressing the diversified

needs of and increasing the benefits provided to patients and their families

as shown by itshuman health care (hhc) mission.

® About Inovelon(rufinamide)

Rufinamide is a triazole derivative that is structurally unrelated to currently

marketed antiepileptic drugs (AEDs). It is believed to regulate the activity of

sodium channels in the brain which carry excessive electrical charges. The

agent was approved for adjunctive therapy for LGS in Europe (under the

[3] brand name Inovelon) in 2007. Inovelon is available as film-coated tablets

containing 100mg, 200mg, and 400mg rufinamide.

The film-coated formulation of rufinamide was first launched in Europe inMay 2007and is now available in 19 European countries.

About Lennox-Gastaut Syndrome

LGS is a debilitating form of childhood-onset epilepsy that most often

appears between the ages of two and seven years. It is characterised by

frequent and multiple seizure types, and is often accompanied by mental

[4] retardation, and psychological and behavioural problems.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world,

[5] affecting approximately eight in 1,000 people in Europe. There are an

[6] estimated six million people living with epilepsy in Europe and estimated

[7] 50 million people worldwide - 10.5 million of which are children under the

[8] age of 15.

Epilepsy is characterised by abnormal firing of impulses from nerve cells in

the brain causing seizures. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body.

Patients may also experience abnormal sensations, altered behaviour or

altered consciousness. Epilepsy is a disorder with many possible causes.

Often the cause of epilepsy is unknown. However, anything that disturbs the

normal pattern of neuron activity - from illness to brain damage to tumours,

[9] can lead to seizures.

About Eisai Europe 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 anti-epileptic drugs (AEDs) is a major strategic area for Eisai in Europe, the Middle East, Africa and Russia (EMEA).

In Europe, Eisai currently has three marketed treatments including:

® Zonegran (zonisamide) as adjunctive therapy in adult patients with

partial-onset seizures, with or without secondary generalisation. (Zonegran

is under license from the originator Dainippon Sumitomo Pharma). Eisai

has applied for the marketing authorisation for zonisamide as monotherapy

for newly diagnosed epilepsy patients with partial seizures, with or without

second generalisation

® 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 adjunctive treatment, 4 years and older of

seizures associated with Lennox-Gastaut Syndrome

About Eisai

Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.

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 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East

and Russia.

For further information please visit our web site

References

http://www.eisai.com.

1. Kenou van Rijckevorsel Treatment of Lennox-Gastaut syndrome:

overview and recent findings. Neuropsychiatr Dis Treat. 2008

December; 4(6): 1001-1019.

2. MedScape references Lennox-Gastaut

Syndromehttp://emedicine.medscape.com/article/1176735-overview

(AccessedFebruary 2012)

3. Inovelon tablets Summary of Product Characteristics

http://www.medicines.org.uk/emc/medicine/20165/SPC/

[http://www.medicines.org.uk/emc/medicine/20165/SPC] (Accessed

January 2012)

4. International Journal of Pharma and Bio Sciences. http://www.ijpbs.net/issue-3/82.pdf(AccessedFebruary 2012)

5. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review

with economic modeling. Epilepsia 2007: 48(12) 2224-2233

6. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering

Epilepsy Care in Europe 2010. Available from;http://www.ilae-

epilepsy.org/Visitors/Documents/EUROReport160510.pdf(Accessed

February 2011)

7. Epilepsy Society UK:

http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-

didyouknow(AccessedFebruary 2012)

8. Forsgren L. Epilepsy in Children. 2nd Ed London. Arnold, 2004. 21-25

9. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from

URL:http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm

(AccessedFebruary 2012)

Date of preparation:January 2013

Job code: Inovelon-UK2277