HATFIELD, England, March 15, 2012 /PRNewswire/ --
Child friendly formulation set to aid administration for the treatment of Lennox-Gastaut syndrome for patients in Germany
Eisai Europe Limited today announced the launch of Inovelon(R) (rufinamide) oral suspension for adjunctive (add-on) treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older, in Germany. As many patients who receive the orphan drug rufinamide are children, the new formulation has been developed as a child friendly drinkable liquid to aid the administration of treatment.
"As some children might find conventional tablets difficult to swallow, there is a strong need for drinkable medicines especially when treating younger epilepsy patients. In addition, administration of suspension allows for individual titration in smaller steps to find the optimal dose for each patient" added Dr. Thomas Bast, Head of the Department of children and adolescents, Epilepsy Centre Kork, Kehl, Germany. "The availability of the suspension formulation of rufinamide will provide patients and caregivers with the choice of their preferred method of administration, which can result in better treatment adherence."
LGS is a rare form of epilepsy accounting for five percent of all cases and rising to approximately 10 percent of childhood epilepsy cases. The annual incidence of the condition affects about 2.8 per 10,000 births in Europe. Effective LGS management and compliance to treatment is of key importance to children as the condition is characterised by multiple daily seizures, mental retardation and regression.
"The launch of the new drinkable form of rufinamide in Germany and shortly in Austria will help to narrow the gap between the available treatments for LGS and the needs of children and young people with this severe form of epilepsy. As a consequence, it could make LGS treatment more manageable supporting compliance with treatment, one of the key factors in reducing seizure frequencies particularly for young people with severe epilepsy." said Dr Andreas Mommertz, Brand Director, Eisai Germany. "Eisai is working closely with epilepsy centres to ensure the treatment is available to patients as soon as possible."
The oral suspension is identical in preparation to the currently marketed rufinamide tablet on a milligram per milligram basis. Germany is the first country in Europe where the new suspension formulation will be available, followed shortly by Austria in April. The suspension formulation will 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(R) in the US).
The development of an oral 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.