rufinamide (Inovelon)

following an abbreviated submission:

rufinamide 40mg/mL oral suspension (Inovelon®) is accepted for restricted use within NHS Scotland.

Indication under review: adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 4 years of age or older.

SMC restriction: restricted to use in patients who have failed treatment with or are intolerant of other antiepileptic drugs.

Adjunctive rufinamide significantly reduced the frequency of total seizures and tonic-atonic seizures and significantly improved seizure severity when compared to placebo in patients with LGS. The oral suspension is bioequivalent to the tablets and provides an alternative formulation for patients who have difficulty swallowing.  Depending on the dose it may be more expensive than the tablets but any overall budget impact is likely to be small.