Inovelon®(rufinamide) Oral Suspension Formulation Launched in France

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

Child friendly formulation will help treatment of orphan syndrome LGS a severe form of childhood epilepsy

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 France. The new formulation of the orphan drug has been developed as a child friendly drinkable liquid to aid the administration of treatment.

LGS is one of the most severe forms of childhood epilepsy accounting for four per cent of epilepsy in children.^[1] The rare but serious condition affects approximately 11,000 children across Western Europe and the peak age of onset is between ages three and five.^[2] The condition is characterised by multiple daily seizures and people with the condition can have up to 70 seizures a day.^[3] Two in three individuals with LGS experience at least one prolonged period of seizure causing confusion and a loss of alertness lasting from hours to weeks.^[4] Most children with LGS also experience developmental problems leading to impaired intellectual functioning and behavioural issues.^[5] LGS is one of the most drug-resistant forms of childhood epilepsy and effective management of the condition is often very difficult, reiterating the importance for children to adhere to treatments protocols.

"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 Professor Stephane Auvin, Epileptologist and Child Neurologist at the Robert Debré Children's Hospital, Paris, France. "The availability of the suspension formulation of rufinamide will potentially help young patients adhere better to treatment which may help improve outcomes in the management of this severe and highly debilitating disease."

"The launch of Inovelon suspension in France may help improve the care 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, and an oral suspension formulation may help aid compliance", said Bashar Allaf, Medical Manager for Epilepsy, Eisai France. "Eisai is working closely with epilepsy centres across the country to ensure the new treatment is available to people with LGS as soon as possible.  This move is entirely in line with our on-going commitment to improve the lives of people with epilepsy and their families."

The oral suspension formulation is identical in preparation to the currently marketed rufinamide tablet on a milligram per milligram basis. The new suspension was launched in Germany, Denmark, Finland, Norway, The Netherlands, Sweden, Spain, Austria and the UK. In addition, it will continue to be launched subsequently in other European countries. 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 to the therapeutic area of epilepsy and further exemplifies the company's human health care (hhc) mission to address the diversified needs of and increase the benefits provided to patients and their families worldwide.

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 seizures associated with LGS in Europe (under the brand name Inovelon) in 2007.^[6] Inovelon is available as film-coated tablets containing 100mg, 200mg, and 400mg rufinamide and as a 40 mg/ml oral suspension. .

The film-coated formulation of rufinamide was first launched in Europe in May 2007 and is now available in 19 European countries. Rufinamide oral suspension received EMA approval in November 2011.

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.^[7]

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.^[8],[9] 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.

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). In Switzerland, Zonegran is only approved as adjunctive therapy.
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL). Zebinix is not approved by Swissmedic.
• 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 is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our 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 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, and 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. From its Europe based Knowledge Centre in Hatfield, UK, Eisai has recently expanded business operations to include the expanded territory of Europe, the Middle East, Africa and Russia (EMEA). Eisai EMEA 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: http://www.eisai.com

References

1. http://ghr.nlm.nih.gov/condition/lennox-gastaut-syndrome

2. http://www.epilepsyfoundation.org/aboutepilepsy/syndromes/lennoxgaustaut/index.cfm

3. http://www.specialchild.com/archives/dz-017.html

4. NINDS Lennox-Gastaut information page. National Institute of Neurological Disorders Web site. http://www.ninds.nih.gov/disorders/lennoxgastautsyndrome/lennoxgastautsyndrome.htm. Updated June 15, 2010. Accessed March 28, 2011.

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

6. 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)

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

8. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf ] (Accessed August 2012)

9. Pugliatti M, et al. Epilepsia Estimating the cost of epilepsy in Europe: a review with economic modelling. 2007:   48(12);2224-2233

Date of preparation: March 2013

Job code: Inovelon-EU0007