Inovelon® (rufinamide) Drinkable Suspension Formulation Launched in the UK

HATFIELD, England, April 13, 2012 /PRNewswire/ --

Child-friendly formulation provides choice for children and young people with Lennox-Gastaut syndrome

Eisai Europe Limited today announced the launch of Inovelon^® (rufinamide) oral suspension for the adjunctive (add-on) treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older in the UK. Many patients who receive the orphan drug rufinamide are children and this new formulation has been developed as a child-friendly, orange-flavoured drinkable liquid to aid the administration of treatment.

"Many children (and in fact adults), particularly those with complex epilepsy and associated neurodevelopmental problems such as LGS experience difficulties with swallowing tablets. A suspension formulation of new and targeted medication is always welcome therefore to widen the availability to the full population of affected individuals," added Helen Cross, Head of Neuroscience Unit, UCL Institute of Child Health, London.

(Please note rufinamide is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 4 years of age and older.)

LGS is a severe, rare form of epilepsy accounting for five percent of all cases and rising to approximately 10 percent of childhood epilepsy cases.^[1] The annual incidence of the condition affects up to 2.8 per 10,000 births in Europe.^[1]  Treatment compliance is key to effective LGS management in children as the disease is characterised by multiple daily seizures, mental retardation and regression.^[2]

"We are delighted to announce the launch of rufinamide in the UK. The availability of the oral suspension formulation will hopefully make treatment easier for children and young people with LGS. At Eisai, our human health care (hhc) mission aims to increase the benefits of treatment provided to patients and their families and we believe that this new formulation underscores this principle. Our efforts are now focused to ensure that this new formulation is made available at centres throughout the UK as soon as possible," said Mike Bee, Epilepsy Business Unit Director, EU North.

The oral suspension is dose equivalent to the currently marketed rufinamide tablet on a milligram per milligram basis. The UK, along with The Netherlands follows Germany in the European launch of Inovelon. Other European countries will launch the new formulation later this year. Rufinamide oral suspension received positive CHMP opinion in September 2011 and formal EMA approval was granted in November 2011. The preparation was approved by the FDA and launched in the US in March 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 its human 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 brand name Inovelon) in 2007.^[3] Inovelon is available as film-coated tablets containing 100mg, 200mg, and 400mg rufinamide. It is available in some countries as an oral suspension in orange flavour 40mg/ml concentration. The oral suspension formulation is bioequivalent to the tablet formulation on a milligram per milligram basis.

The film-coated formulation of rufinamide was first launched in Europe in May 2007 and 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 retardation, and psychological and behavioural problems.^[4]

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 estimated 50 million people worldwide,^[7] 10.5 million of which are children under the age of 15.^[8]

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, can lead to seizures.^[9]

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 the European market.

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 is one of the world's leading R&D-based pharmaceutical companies and has defined its 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 recently expanded its UK Hatfield facility which now supports the company's growing European, Middle Eastern and African (EMEA) business.

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

• Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression
• Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
• Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's 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, and Belgium.

For further information please visit our Web site http://www.eisai.com

References

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 Syndrome http://emedicine.medscape.com/article/1176735-overview (Accessed February 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 (Accessed February 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 (Accessed February 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 (Accessed February 2012)