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 Eisais commitment in the therapeutic area of epilepsy and further exemplifies the companys 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]
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Swissmedic approves Eisai´s Inovelon® (rufinamide) oral suspension formulation for seizures associated with Lennox ...