Epilepsy Therapy Xcopri Designated Schedule V Controlled Substance

The Drug Enforcement Administration (DEA) has designated Xcopri (cenobamate; SK Life Science) as a schedule V controlled substance, indicating a lower potential for abuse.

Xcopri was approved by the Food and Drug Administration (FDA) in November 2019 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 (GABA_A) ion channel.

The approval was based on 2 double-blind, placebo-controlled studies in adult patients with partial-onset seizures with or without secondary generalization who were not adequately controlled with 1 to 3 concomitant antiepileptic drugs. Patients in these studies had a mean duration of epilepsy of approximately 24 years and median seizure frequency of 8.5 seizures per 28 days.

In a human abuse potential study conducted in recreational sedative abusers, euphoric mood was found to occur at a greater extent with Xcopri (400mg) than with placebo (8% vs 0%, respectively). In phase 2 and 3 studies involving epilepsy patients, euphoric mood, confusional state, and sedation occurred at low rates in patients who received Xcopri (0.5-2.5%).

Clinical studies in healthy individuals indicate that Xcopri may cause physical dependence and lead to a withdrawal syndrome characterized by insomnia, decreased appetite, depressed mood, tremor, and amnesia. Xcopri should be withdrawn gradually over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal.

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