FDA Approves New Administration Methods for SK Life Science’s Xcopri for Adults with Partial-Onset Seizures

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SK Life Science announced that the FDA has approved two new ingestion methods for Xcopri (cenobamate tablets) CV, an antiseizure medication. As of today, the medication can be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.

These new methods of administration were approved as a result of the results of an open-label, randomized, single-center, three-period, six-sequence, crossover study showing biochemical similarity between three administration routes, including the aforementioned methods.¹

"The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole," said Louis Ferrari, BS, RPh, MBA, VP, medical affairs, SK Life Science, in a press release. "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 healthcare providers managing their care."

Xcopri was first approved by the FDA for the treatment of partial-onset seizures in adults in November 2019. According to a company press release, it was the first time that a company based in Korea initiated the discovery of a compound all the way to approval by the FDA. The initial approval was based on the results of a two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study that enrolled adults with uncontrolled partial-onset seizures, taking one to three concomitant anti-epileptic drugs (AEDs). The results showed that Xcopri provided a substantial reduction in seizure occurrences as opposed to placebo.²

"Approximately 3 million adults live with epilepsy in the US and according to the Centers for Disease Control and Prevention (CDC), nearly 60% reported having seizures, even if they took an AED," said Beth Lewin Dean, CEO, Citizens United for Research in Epilepsy (CURE), in a press release. "There is an urgent need to advance research and introduce new treatment options. The FDA approval of Xcorpi for the treatment of partial-onset seizures is a welcome option for the epilepsy community."

The Centers for Disease Controland Prevention (CDC) defines epilepsy as a brain disorder that causes seizures. While there are many causes of epilepsy, it is also common for there to be no explanation. However, known causes include stroke, brain tumors, traumatic brain and head injuries, and infections to the central nervous system.³

“Epilepsy can affect people in very different ways. This is because there are many causes and many different kinds of seizures,” reports the CDC. “Some people may have multiple types of seizures or other medical conditions in addition to epilepsy. These factors play a major role in determining both the severity of the person’s condition and the impact it has on his or her life.”

References

1. 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. PR Newswire. April 11, 2024. Accessed April 11, 2024. https://www.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. FDA Approves XCOPRI® (cenobamate tablets), an Anti-Epileptic Drug (AED) from SK Biopharmaceuticals, Co., Ltd., and U.S. Subsidiary SK Life Science, Inc. PR Newswire. November 21, 2019. Accessed April 11, 2024. https://www.prnewswire.com/news-releases/fda-approves-xcopri-cenobamate-tablets-an-anti-epileptic-drug-aed-from-sk-biopharmaceuticals-co-ltd-and-us-subsidiary-sk-life-science-inc-300963478.html

3. Epilepsy Fast Facts. CDC. Accessed April 11, 2024. https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy.