SK Biopharmaceuticals launches phase 3 trial of seizures drug cenobamate in Asia
SK Biopharmaceuticals, a South Korean pharma company, has revealed plans to initiate a phase 3 clinical trial for its FDA-approved seizures drug cenobamate in Asia.
Cenobamate was approved by the US Food and Drug Administration as an anti-seizure medication (ASM) under the brand name XCOPRI for the treatment of partial-onset seizures in adults. (Read here : XCOPRI FDA approval)
The phase 3 clinical trial of the seizures drug will be initiated in Korea with the Korean Ministry of Food and Drug Safety’s (MFDS) recently accepting SK Biopharmaceuticals’ investigational new drug (IND) application.
The South Korean pharma company expects to enroll over 500 patients from China, Japan, and Korea in the late-stage clinical trial.
In China as well, SK Biopharmaceuticals secured approval for initiating the phase 3 clinical trial and also a separate phase 1 clinical trial from China’s National Medical Products Administration (NMPA).
SK Biopharmaceuticals said that it also intends to submit a clinical trial notification (CTN) next month for the phase 3 trial to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
According to the South Korean pharma company, the phase 3 clinical trial is a randomized, double-blind, placebo-controlled, multicenter study, which will assess the efficacy and safety of cenobamate as an adjunctive therapy in patients having partial-onset seizures. The trial will have an optional open-label extension, said the company which is engaged in research, development, and commercialization of treatments for central nervous system (CNS) disorders.
Jungshin Park – SK Biopharmaceuticals drug development business vice president said: “The initiation of the Phase 3 clinical trial in Asia is a major milestone for cenobamate in our continuous effort to address unmet needs in epilepsy and central nervous system disorders worldwide.
“SK Biopharmaceuticals has been planning to enter Asian markets after launching our anti-seizure medication in the U.S. and forming a partnership for commercialization in Europe. We are pleased to move forward as intended to expand our global footprint.”