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 (GABAA) 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 Xcopri should be withdrawn gradually over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal.
“With the DEA’s decision to designate Xcopri as a Schedule V medicine, the final step of the regulatory approval process is complete,” said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science. “We are moving forward to launch Xcopri as planned in the second quarter of 2020 and remain steadfast in our commitment to addressing unmet needs for patients with epilepsy.”
Xcopri will be available in 6 tablet strengths (12.5mg, 25mg, 50mg, 100mg, 150mg, 200mg) in various package sizes.
For more information visit sklifescienceinc.com.