Updated on 15 April 2015
CFDA approves ph III development of epilespy drug in China
Singapore: Chinese Food and Drug Administration (CFDA) has approved Israel based D-Pharm to conduct clinical development of epilepsy drug, DP-VPA, through Phase 3 level in China.
The company stated that prior to the IND approval, DP-VPA was granted fast track status, a designation designed to bring important new drugs which treat a serious or life-threatening condition and fill an unmet medical need to patients earlier.
Dr Alex Kozak, CEO, D-Pharm commented, "Development of DP-VPA in China creates value and paves the way for our own development of this exciting product in major pharmaceutical markets."
DP-VPA, a novel drug discovered and developed by D-Pharm, is a derivative of the valproic acid (VPA). VPA is the active ingredient in one of the best antiepileptic drugs, with combined peak sales over USD1 billion in epilepsy, migraine and bipolar disorder. In Phase 1 and 2 clinical studies DP-VPA showed safety and efficacy in epilepsy patients.