All Wales Strategic Medical Group and Scottish Medicines Consortium Accept use of Inovelon® (rufinamide) Drinkable, Child-friendly Formulation

HATFIELD, England, November 6, 2012 /PRNewswire/ --

New option provides choice for children and young people with Lennox-Gastaut syndrome,

 a severe form of epilepsy

The All Wales Strategic Medical Group (AWSMG) and Scottish Medicines Consortium (SMC) has accepted the use of Inovelon^® (rufinamide) oral suspension for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a highly debilitating form of epilepsy, in children four years and older in Wales and Scotland. The AWSMG and SMC have restricted its use to patients who have failed treatment with, or are intolerant of, other antiepileptic drugs.^[1],[2]

The AWSMG and SMC's decision to accept the use of rufinamide oral suspension follows their approval of the tablet formulation in 2008 based on data showing that it can significantly reduce the frequency of total and tonic-atonic seizures, and significantly improve seizure severity, when compared to placebo in patients with LGS.^[3] The oral suspension was shown to be bioequivalent and cause minimal budget impact in Scotland and Wales, and was therefore subsequently approved following an abbreviated submission. 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.

"As some children find tablets difficult to swallow, there is a strong need for drinkable medicines especially when treating younger LGS patients," said Helen Cross, Head of Neuroscience Unit, University College London, Institute of Child Health. "Access to the suspension formulation of rufinamide may potentially help young people adhere better to treatment and ultimately may lead to improved outcomes in the management of this severe and highly debilitating disease."

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.^[4] The annual incidence of the condition affects up to 2.8 per 10,000 births in Europe.^[4] Treatment adherence is key to effective LGS management in children as the disease is characterised by multiple daily seizures, mental retardation and regression.^[5]

"The AWSMG and SMC's approval of the new drinkable form of rufinamide is important as it may help address the adherence needs of children and young people with this severe form of epilepsy," said Mike Bee, Epilepsy Business Unit Director, EU North. "These approvals are in line with our on-going commitment to the therapeutic area of epilepsy and exemplifies our drive to increase the benefits our medicines provide patients and their families through Eisai's human health care (hhc) mission."

The oral suspension is dose equivalent to the currently marketed rufinamide tablet on a milligram per milligram basis. The AWSMG and SMC approval for the use of the oral suspension follows launches of the medicine in the UK, The Netherlands and Germany. 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).  

- ENDS -

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] Rufinamide 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 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.^[6]

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 with the condition worldwide, 10.5 million of which are children under the age of 15.^[7],[8],[9] In Scotland it affects nearly 40,000 people.^[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.^[11]

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

In the EMEA region, Eisai currently has four marketed treatments including:

• Zonegran^® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (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
• 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

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 http://www.eisai.com.

References

1. Scottish Medicines Consortium. Inovelon product update. http://www.scottishmedicines.org.uk/files/advice/rufinamide_Inovelon_ABBREVIATED_June_2012_for_website.pdf.  Last accessed 3 September 2012

2. All Wales Strategic Medicines Group. Inovelon product update.
http://www.wales.nhs.uk/sites3/Documents/371/rufinamide%20%28Inovelon%29%20FAR.pdf. Last accessed 2 November 2012

3. Inovelon tablets Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/20165/SPC/. (Accessed January 2012)

4. Kenou van Rijckevorsel Treatment of Lennox-Gastaut syndrome: overview and recent findings. Neuropsychiatr Dis Treat. 2008 December; 4(6): 1001-1019.

5. MedScape references Lennox-Gastaut Syndrome http://emedicine.medscape.com/article/1176735-overview (Accessed February 2012)

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

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

8. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224-2233

9. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed February 2012)

10. Epilepsy Scotland available at: http://www.epilepsyscotland.org.uk/ (Accessed 01 November 2010).

11. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from URL: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (Accessed February 2012)

Date of preparation: November 2012
Job code: Inovelon-UK2271