Paramus - SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals, Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) approved two new administration options of XCOPRI (cenobamate tablets) CV, an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, which can now be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.
'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, vice president, Medical Affairs at SK Life Science. '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.'
The FDA-approved label update considered the results of an open-label, randomized, single-center, 3- period, 6-sequence, balanced crossover study demonstrating bioequivalence between three administration routes including swallowing an intact tablet, as a crushed tablet suspended in water and taken orally, and as a crushed tablet suspended in water and administered via a nasogastric tube.
About Epilepsy
Epilepsy is the fourth most common neurological disorder. There are approximately 3.4 million people living with epilepsy in the United States, with 150,000 new cases each year in the country.1,2 Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one's safety, relationships, work, driving, and much more.3,4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).3,4 Despite the availability of many antiepileptic therapies, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.
About XCOPRI (cenobamate tablets) CV
Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the -aminobutyric acid (GABAA) ion channel. Cenobamate is approved in the United States for the treatment of partial-onset seizures in adults and is available under the brand name XCOPRI (cenobamate tablets) CV. Cenobamate can be combined with other ASMs or used alone. The recommended initial dosage of cenobamate is 12.5 mg once-daily, with titration every two weeks; it is available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.
Cenobamate is also approved in the European Union and the United Kingdom for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizures that have not been adequately controlled despite a history of treatment with at least two antiepileptic medicinal products and is marketed by Angelini Pharma under the brand name ONTOZRY . Additionally, cenobamate is in clinical development in Asia. Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercialize cenobamate in Japan and in the Greater China region, respectively. SK Biopharmaceuticals has recently entered into an exclusive licensing agreement with Endo for cenobamate in Canada.
About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.
SK Biopharmaceuticals and its U.S. subsidiary SK Life Science are pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin their expansion into oncology through research and development efforts. The companies have a pipeline of eight compounds in development in both CNS disorders and oncology. Additionally, SK Biopharmaceuticals is focused on the discovery of new treatments in oncology.
Both SK Biopharmaceuticals and SK Life Science are part of SK Group, one of the largest conglomerates in Korea. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses.
Contact:
Email: Info@SKLSI.com
SK BIOPHARMACEUTICALS CO., LTD. 
