FDA Updates Approval of Antiseizure Medication Cenobamate Allowing for Alternative Administration Methods

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In addition to oral administration, patients with partial-onset seizures can now take the antiseizure medication via a nasogastric tube if the tablet is crushed and mixed with water.

Patient taking oral tablet with water -- Image credit: New Africa | stock.adobe.com

Image credit: New Africa | stock.adobe.com

The FDA has approved 2 new administration methods for the antiseizure medication (ASM) cenobamate tablets (Xcopri; SK Biopharmaceuticals). The medication is indicated for adult patients with partial-onset seizures, and the drug can now be crushed and mixed with water to be administered either orally or via a nasogastric tube.1

Cenobamate is an ASM that is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents in the body, though the precise mechanism of its therapeutic effect is not known. Experts note that it is also a positive allosteric modulator of the γ-aminobutyric acid ion channel. The drug can be used either alone or in combination with other ASMs, and the recommended dose is 12.5 mg once per day with titration every 2 weeks, but it is available in 5 other doses: 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.1

"The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting [cenobamate tablets], but are unable to swallow the tablets whole," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science, in a press release.1

Cenobamate was initially approved in 2019 following results from 2 randomized, double-blind, placebo-controlled studies that enrolled a total of 655 adult patients who experience partial-onset seizures and were enrolled whether or not they had secondary generalization for an average of 24 years and median seizure frequency of 8.5 seizures per 28 days during an 8-week baseline period.2

The trials demonstrated that patients who were in the cenobamate group and received daily doses of 100, 200, and 400 mg experienced a reduced percentage of seizures per 28 days compared with those who received placebo. The recommended dose of cenobamate following an adjustment period was determined to be 200 mg daily; however, some patients may need to titrate up to 400 mg per day—the maximum dose available—depending on their clinical response and ability to tolerate the drug.2

“[Cenobamate] is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” said Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a press release. “Patients can have different responses to the various ASMs that are available. This approval provides an additional needed treatment option for people with this condition.”2

The updated alternative administration methods follows results of an open-label, randomized, single-center, 3-period, 6-sequence, balanced crossover study that demonstrated bioequivalence between different administration routes. Patients were randomly assigned to receive cenobamate through 1 of 3 different administration routes—swallowing an intact tablet, orally receiving a crushed tablet in water, or a crushed tablet in water via a nasogastric tube—to determine differences in the administration methods.1

Potential adverse effects (AEs) of cenobamate include depressive symptoms, suicidal thoughts or behaviors, and neurological reactions such as somnolence, fatigue, dizziness, and difficulty with walking and coordination. Common AEs reported by patients in clinical trials included somnolence, dizziness, fatigue, double vision, and headaches.1,2

"In some patients, crushing tablets offers an additional option for dosing and administration by nasogastric tube. This label update addresses an unmet need for this patient population and offers administration alternatives to the health care providers managing their care," said Ferrari in a press release.1

References

1. PR Newswire. XCOPRI® (cenobamate tablets) CV Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube. News release. April 11, 2024. Accessed April 12, 2024. https://prnmedia.prnewswire.com/news-releases/xcopri-cenobamate-tablets-cv-receives-fda-approval-for-alternate-methods-of-administration-that-include-crushed-tablet-in-liquid-suspension-taken-orally-or-through-a-nasogastric-tube-302113538.html
2. US Food & Drug Administration. FDA approves new treatment for adults with partial-onset seizures. News release. November 21, 2019. Accessed April 12, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-partial-onset-seizures
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