Key Facts:

• FDA has accepted for review the New Drug Application (NDA) for an investigational oral suspension formulation of cenobamate for the treatment of focal seizures in adults.
• The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2027.
• The investigational oral suspension formulation is intended to provide an alternative administration option for patients who may have difficulty swallowing tablets.
• Cenobamate tablets are currently approved in the United States for the treatment of focal seizures in adults.
• SK Life Science remains committed to advancing patient-centered treatment options that address real-world unmet needs in epilepsy care.

PARAMUS, N.J., June 15, 2026 /PRNewswire/ — SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for an investigational oral suspension formulation of cenobamate for the treatment of focal seizures in adults. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2027.

The investigational oral suspension formulation is intended to provide an alternative administration option for people living with epilepsy who may have difficulty swallowing tablets and may help address important unmet patient needs.

Executive Commentary
“FDA acceptance of this NDA reflects our continued commitment to broadening treatment options for people living with epilepsy,” said Donghoon Lee, Chief Executive Officer of SK Life Science, Inc. “By advancing a cenobamate oral suspension formulation, we aim to help address unmet need among patients who cannot swallow tablets and further support individualized care across the epilepsy community.”

“At SK Life Science, we remain focused on developing patient-centered solutions that reflect the real-world needs of people living with epilepsy and their caregivers,” said Sunita Misra, MD, PhD, Chief Medical Officer, SK Life Science, Inc. “The FDA’s acceptance of this application for review marks an important milestone, and we look forward to continuing to work closely with the FDA as we advance toward the PDUFA date.”

Cenobamate tablets are currently approved in the United States for the treatment of focal seizures in adults.

About Epilepsy
Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures and is the fourth most common neurological condition.

• Approximately 3.4 million people in the United States are living with epilepsy
• Approximately 150,000 new cases are diagnosed each year in the U.S.
• Nearly 40% of people with epilepsy do not achieve seizure freedom despite available treatments

According to the Centers for Disease Control and Prevention and the Epilepsy Foundation, epilepsy can impact safety, daily functioning, and overall quality of life.

FAQ

What is being announced?
The FDA accepted for review the New Drug Application (NDA) for an investigational oral suspension formulation of cenobamate for the treatment of focal seizures in adults and assigned a PDUFA target action date of January 31, 2027.

Why is SK Life Science developing an oral suspension formulation of cenobamate?
The investigational oral suspension formulation is intended to provide an alternative administration option for people living with epilepsy who may have difficulty swallowing tablets. SK Life Science is committed to helping address unmet patient needs and supporting individualized care.

Is cenobamate currently approved in the United States?
Yes, cenobamate tablets are currently approved in the United States for the treatment of focal seizures in adults.

Does FDA acceptance mean the product is approved?
No. FDA acceptance for review means the agency determined that the application is sufficiently complete to begin its formal review process. The investigational oral suspension formulation has not been approved by the FDA.

What is the PDUFA date?
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2027. The PDUFA date is the FDA’s target date for completing its review of the application.

What data supported the NDA submission?
The NDA submission includes data intended to support the safety, tolerability, and pharmacokinetic profile of the investigational oral suspension formulation of cenobamate.

What are the next steps in the regulatory process?
SK Life Science will continue to work closely with the FDA throughout the review process as the agency evaluates the application ahead of the PDUFA target action date.

About SK Life Science, Inc. and SK Biopharmaceuticals Co., Ltd.
SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with 12 compounds currently in development. Utilizing target-based drug discovery, high-throughput organic screening/high content screening, computer-aided drug design, combinatorial chemistry, and integrating artificial intelligence across discovery, development, and operations to accelerate innovation, the companies drive R&D efforts in biology/discovery, medicinal chemistry, pharmacology, and clinical development. For more information, visit www.sklifescienceinc.com.

About XCOPRI® (cenobamate tablets) CV
Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium current and enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABA_A) ion channel. The precise mechanism by which cenobamate exerts its therapeutic effect is unknown.

Cenobamate is marketed under the brand name XCOPRI® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals’ partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV

DO NOT TAKE XCOPRI IF YOU:

• Are allergic to cenobamate or any of the other ingredients in XCOPRI.
• Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.

XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider.

QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.

Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Liver problems: XCOPRI may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start XCOPRI and while you take XCOPRI if needed. Tell your healthcare provider right away if you have any symptoms of liver problems, such as: yellowing of the skin and eyes (jaundice), nausea, vomiting, unusual darkening of the urine, or feeling tired or weak.

Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.

DISCONTINUATION: 

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

DRUG INTERACTIONS: 

XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

PREGNANCY AND LACTATION: 

XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use.

Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org.

Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI. 

COMMON SIDE EFFECTS: 

The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired. 

These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

DRUG ABUSE: 

XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law.

INDICATION: 

XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age. 

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. 

Please see full Prescribing Information.

XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd.

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SOURCE SK Life Science, Inc.