Health Canada has accepted the New Drug Submission (NDS ) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients.
The treatment is intended for such patients who are not well-controlled with standard therapy.
The regulatory agency is anticipated to provide a decision on whether cenobamate tablets can be commercialised and sold in Canada under this NDS in the middle of next year.
Paladin noted that the regulatory filing comprises efficacy data from C013 and C017 pivotal studies, which enrolled 658 subjects.
The filing also comprised the safety analysis carried out during the course of these studies as well as their open-label extensions and is accompanied by a long-term open-label Phase III C021 safety trial.
In the clinical development programme, 1,944 epilepsy patients received cenobamate treatment.
Discovered by SK Biopharmaceuticals and SK life science, cenobamate is a new small molecule anti-seizure therapy.
Under the deal, Paladin Labs will oversee all commercial activities linked to cenobamate in Canada.
Paladin Labs vice-president and general manager Livio Di Francesco said: “This is an important step in our journey to address the unmet needs of adult patients diagnosed with partial-onset seizures.
“Paladin Labs is committed to working collaboratively with regulatory, pricing and reimbursement authorities in order to provide cenobamate to appropriate patients as quickly as possible.”