Friday, May 24, 2024

Epilepsy Management Enhanced: SK Life Science Announces FDA Approval for Additional XCOPRI® Administration Options

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SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals, Co., Ltd., made a significant announcement regarding the approval by the U.S. Food and Drug Administration (FDA) of two additional administration methods for XCOPRI® (cenobamate tablets) CV. This antiseizure medication (ASM) is specifically indicated for epilepsy patients with partial-onset (focal) seizures, and the recent approval introduces alternative options for administering XCOPRI tablets. Now, patients have the flexibility to crush the tablets and mix them with water, facilitating administration either orally as a suspension or via a nasogastric tube.

This expansion of administration options represents a noteworthy development in the management of epilepsy, offering enhanced flexibility and accessibility for patients who may face challenges in swallowing whole tablets. The approval reflects a concerted effort to address the diverse needs of individuals with epilepsy and to provide healthcare providers with additional tools for optimizing patient care. It also underscores the commitment of SK Life Science, Inc., and SK Biopharmaceuticals, Co., Ltd., to advancing treatment options for neurological disorders.

The approval by the FDA comes after a thorough evaluation of clinical data demonstrating the safety, efficacy, and bioequivalence of the alternative administration methods for XCOPRI. This data-driven decision assures healthcare professionals and patients alike, ensuring that the new administration options maintain the medication’s therapeutic integrity and efficacy.

New XCOPRI® Administration Methods Offer Enhanced Flexibility for Epilepsy Treatment

With the availability of these new administration methods, patients with epilepsy and their healthcare providers can now tailor treatment plans more effectively to meet individual needs and preferences. For patients who struggle with swallowing whole tablets, the ability to administer XCOPRI as a suspension offers a more accessible and comfortable alternative, potentially enhancing medication adherence and treatment outcomes.

Louis Ferrari, vice president of Medical Affairs at SK Life Science, Inc., emphasized the significance of this approval in addressing the needs of patients with epilepsy. He highlighted the importance of providing diverse administration options to accommodate the unique challenges faced by individuals living with this neurological disorder. By offering flexibility in how XCOPRI is administered, healthcare providers can better support their patients in managing their condition and improving their quality of life.

In addition to expanding administration options, SK Life Science, Inc., remains committed to ongoing research and development efforts aimed at further advancing the treatment landscape for epilepsy and other central nervous system (CNS) disorders. By continuously innovating and adapting to the evolving needs of patients and healthcare providers, the company seeks to make meaningful contributions to improving outcomes and enhancing the well-being of individuals affected by neurological conditions.


SK Life Science’s XCOPRI® Wins FDA Nod for New Administration Methods

Louis Ferrari, vice president of Medical Affairs at SK Life Science, emphasized that this approval addresses the needs of epilepsy patients who have difficulty swallowing whole tablets. For some patients, crushing tablets provide an additional dosing option, especially for those who require administration via a nasogastric tube. This label update aims to fulfill an unmet need within this patient population and offers healthcare providers more flexibility in managing their care.

The FDA approval was based on data from a study that demonstrated bioequivalence between three administration routes: swallowing an intact tablet, taking a crushed tablet suspended in water orally, and administering a crushed tablet suspended in water through a nasogastric tube.

Epilepsy, the fourth most common neurological disorder, affects approximately 3.4 million people in the United States, with 150,000 new cases reported annually. It is characterized by recurrent, unprovoked seizures, which can significantly impact various aspects of a person’s life, including safety, relationships, work, and driving. Despite the availability of multiple antiepileptic therapies, nearly 40 percent of individuals with epilepsy continue to experience uncontrolled seizures.

A Novel ASM for Epilepsy with Global Approvals and Ongoing Expansion in Asia

XCOPRI® (cenobamate tablets) CV is an ASM developed by SK Biopharmaceuticals and SK Life Science. While the precise mechanism of action is not fully understood, cenobamate is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents and acting as a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel. It is indicated for the treatment of partial-onset seizures in adults and is available in various tablet strengths for once-daily dosing.

Additionally, cenobamate is approved in the European Union and the United Kingdom under the brand name ONTOZRY® for the adjunctive treatment of focal-onset seizures in adult patients. Clinical development of cenobamate is ongoing in Asia, with licensing agreements established for its development and commercialization in Japan, the Greater China region, and Canada.


Resource: SK Life Science, April 11, 2024

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