Within the Framework of Import Substiution Strategy
Early next year the R-Pharm Group expects authorization of a new antiepileptic agent of valproic acid, developed under support of Federal Target Program “Development of Pharmaceutical and Healthcare Industry of the Russian Federation till 2020 and further”. Clinical trials have already been completed, with results proving compliance of the generic drug for treatment of different forms of epilepsy to the international original drug.
An open randomized, crossover, two-period, comparative bioequivalence study of valproic acid, prolonged-release film-coated tablets, 500 mg (JSC R-Pharm, Russia) and an international reference drug in healthy volunteers was conducted at the Federal State Budgetary Healthcare Institution Hospital of Russian Academy of Science (Troitsk).Comparison of pharmacokinetic parameters of the generic drug to those of the reference drug confirmed bioequivalence of the Russian drug and the international reference drug.
Valproic acid and its salt, sodium valproate, are known to be products of a group of fatty acids with antiepileptic effects. They are considered to be basic antiepileptics of broad spectrum and may be used in different forms of epilepsy Valproic acid is on the Vital and Essential Drugs list and in the latest version of the WHO Essential Medicines List (2015).
Launch of a generic version of delayed release valproic acid will be another step in implementation of drug import substitution strategy.
It is planned to manufacture the product at the R-Pharm Yaroslavl Finished Pharmaceutical Forms Site