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. 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. The condition is characterised by multiple daily seizures and people with the condition can have up to 70 seizures a day. 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. Most children with LGS also experience developmental problems leading to impaired intellectual functioning and behavioural issues. 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. 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.