Swissmedic approves Eisai's Inovelon® (rufinamide) oral suspension formulation for seizures associated with Lennox-Gastaut Syndrome in Switzerland

HATFIELD, England, July 11, 2012 /PRNewswire/ -- Eisai Europe Limited today announces the Swissmedic approval of Inovelon® (rufinamide) oral suspension for adjunctive (add-on) treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients over the age of 4 years in Switzerland. Many patients who receive the orphan drug rufinamide are children, partially disabled, and this new formulation has been developed as a child-friendly, orange-flavoured drinkable liquid to aid the administration of treatment for this rare, severe form of epilepsy.

"Drinkable medicines can be particularly useful for children who find conventional tablets difficult to swallow. The rufinamide suspension formulation will provide patients, parents and caretaker with a new choice of method of administration which could result in better treatment adherence," said Dr Klaus Meyer from Bethesda Tschugg Clinic, Switzerland. "Improving treatment compliance, especially for patients with this severe form of epilepsy, is an important step to help them manage their seizures."

LGS is a rare form of epilepsy accounting for five percent of all cases and rising to approximately 10 percent of childhood therapy resistant epilepsy cases.[1] The annual incidence of the condition affects about 2.8 per 10,000 births in Europe.[1] Effective LGS management and compliance to treatment is of key importance to children and parents as the condition is characterised by multiple daily seizures, mental retardation and regression.[2]

The oral suspension is dose equivalent to currently marketed rufinamide tablets on a milligram per milligram basis. The preparation was approved by the FDA and launched in the US in March 2011 (rufinamide is marketed as BANZEL® in the US) and was launched in Europe in March 2012. 

The development of a 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 200mg, and 400mg rufinamide.

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 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.[8]

About Eisai Switzerland 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 the European market.

In Europe, Eisai currently has two 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)
• Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years

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 their UK Hatfield facility which now supports the company's growing European, Middle Eastern, African and Russian (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, Belgium, Luxembourg, the Middle East and Russia.

For further information please visit our web site www.eisai.com

July 2012 / Inovelon-UK2260

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 Fachinformation at http://www.compendium.ch (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 June 2011)

[7]    Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed June 2011)

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