UK-based Martindale Pharma has announced regulatory clearance of an oral formulation of its epilepsy therapy clobazam in Europe.
The company says its product has now received approvals from France, Ireland, Germany and Italy, where it will be marketed as Epaclo, and in Denmark, Spain and Iceland, under the trade name Silocalm, following the successful completion of a decentralised procedure.
Epaclob/Silocalm are based on Tapclob, the world’s first oral liquid suspension version of clobazam to bag regulatory approval, which has been available from Martindale Pharma in the UK since May 2013.
Clobazam oral suspension is used principally as an adjunctive therapy for epilepsy with the formulation particularly suitable for children and young adults.
“Already an established product in the UK, this formulation not only allows for better ease of use, especially for paediatrics, but will allow both prescribers and patients access to a much needed safe and cost-effective licensed oral liquid formulation when required,” noted Michael Harris, Martindale’s chief executive.
