Belgium’s UCB has presented encouraging data from a late-stage trial of an extended-release version of its anti-epilepsy blockbuster Keppra.
Results from a Phase III trial of Keppra XR (levetiracetam) extended-release tablets showed that the treatment “significantly reduced partial onset seizure frequency when administered as adjunctive therapy for adults with refractory epilepsy”. The data were presented at the American Epilepsy Society meeting in Philadelphia.
The 158-patient study looked at the efficacy, safety, and tolerability of Keppra XR and the average reduction of partial onset seizures in the that arm was 46.1% compared to 33.4% with placebo during the 12- week treatment period. 24% of patients randomised to the extended-release levetiracetam group had seizure frequency per week reduced by 75-100%, compared with 11.4% of patients in the placebo arm. The study also found that the most common reported adverse events that occurred more frequently in the extended-release levetiracetam group were somnolence, influenza, nausea, nasopharyngitis, irritability, and dizziness.
UCB quoted Jukka Peltola of the Tampere University Hospital in Finland as saying that with the new formulation of Keppra, about one in ten patients with refractory partial onset epilepsy achieved seizure freedom. The doctor added that “it is an ongoing need for new antiepileptic drug options and extended release formulations offer the potential advantages of convenience and improved patient compliance”.
The Brussels-headquartered group said it is in the process of submitting a New Drug Application for the use of Keppra XR to the US Food and Drug Administration. An approval would be particularly good news at this time as the original formulation is facing generic competition.
In October, UCB settled a patent dispute with Mylan in a deal which gives the US generics major the right to market its 250mg, 500mg and 750mg versions of generic levetiracetam from November 1 next year, provided that UCB obtains paediatric exclusivity for Keppra. Half-year sales of the drug, which is the market leader in Europe as well as in the USA, climbed 36% to 498 million euros.
