SK Life Science has announced the availability of Xcopri (cenobamate) tablets for the treatment of partial-onset seizures in adults.

The exact mechanism of Xcopri in the treatment of partial-onset seizures is unknown, but it has been shown to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.

The approval was based on 2 randomized, double-blind, placebo-controlled studies (Study 1 and Study 2) in adult patients with partial-onset seizures who were inadequately controlled with 1 to 3 concomitant antiepileptic drugs. Results from both studies demonstrated that treatment with Xcopri significantly reduced seizure frequency compared with placebo at all doses studied.

Regarding safety, the most common adverse reactions (≥10% and more frequently than placebo) include somnolence, dizziness, fatigue, diplopia, and headache. In addition, Xcopri carries the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) when treatment is titrated rapidly (weekly or faster titration). The use of Xcopri is contraindicated in patients with familial short QT syndrome. 

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Xcopri is designated a Schedule V controlled substance. The product is available in 6 tablet strengths (12.5mg, 25mg, 50mg, 100mg, 150mg, 200mg) in various package sizes.

The Company is also offering an extensive patient access program to assist eligible patients prescribed Xcopri.

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