The Drug Enforcement Administration (DEA) has designated cenobamate (Xcopri, SK Biopharmaceuticals, Paramus, NJ) as a Schedule V medicine. Cenobamate was approved by the Food and Drug Administration (FDA) on November 21, 2019, for the treatment of partial-onset seizures in adults.
"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."
Epilepsy is one of the most common neurologic disorders and has significant physical and psychosocial impacts on individuals who are living with this disease. Partial-onset seizures, which begin in just 1 part of the brain, affect approximately 60% of people with epilepsy. Of those with partial-onset seizures, 40% have inadequate control of their seizures, even after treatment with 2 or more antiseizure medications (ASMs). This high rate of medically refractory seizures underscores the need for new treatment options for these individuals.
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