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.

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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).

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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.

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“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.”

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