Published on : Apr 15, 2015
A Chinese firm, named D-Pharm Ltd., has been informed by Jiangsu Nhwa Pharmaceutical Co. Ltd., its development partner, that they have received the approval from the C-FDA for the clinical development for epilepsy treatment known as DP-VPA, via third phase. The specified clinical protocols will be given to the C-FDA before the initiation of any recent study. Nhwa will commence with a connecting safety study, which will be followed by a huge dose-ranging second phase part b clinical study in the epilepsy patients.
Prior to the IND permission, DP-VPA was granted the fast track status for novel drugs, which treat a fatal condition and fill up for the unmet medical requirement to patients. The CEO of D-Pharm, Dr. Alex Kozak stated that the development of DP-VPA in China has created a value and paved the path for their own advancement of this exhilarating product in the major pharmaceutical industries. He said that he is delighted by their thriving partnership with Nhwa and with the imminent approach of the C-FDA.
DP-VPA, a new drug invented and developed by D-Pharm, is derived from the valproic acid (VPA). The VPA is the active component in one of the best antiepileptic medicines, with collective peak sales over US$1 billion in migraine, epilepsy, and bipolar disorder. In second and third phase, the clinical studies on DP-VPA presented that the drug is safe and effective for the treatment of epilepsy patients.
Nhwa and D-Pharm are developing the DP-VPA attributed to a strategic agreement, which was signed in 2011. Nhwa has the responsibility for development, production, registration, and promotion of DP-VPA for epilepsy in Hong Kong, China, and Macau, while D-Pharm has the rights for the drug in the rest of the world.