SK life science To Present Latest XCOPRI® (cenobamate tablets) CV Data at the American Epilepsy Society 2021 Annual Meeting

PARAMUS, N.J., Nov. 29, 2021 /PRNewswire/ — SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an revolutionary world pharmaceutical firm centered on creating therapies for central nervous system (CNS) problems, will current information on its anti-seizure remedy (ASM) XCOPRI (cenobamate tablets) CV on the American Epilepsy Society (AES) Annual Assembly, held December 3-7, 2021 in Chicago, Illinois and just about by way of AES 2021 Digital Choose.

On the assembly, the corporate will current a complete of six posters from varied XCOPRI research, together with a number of post-hoc analyses from examine C021 analyzing long-term security and efficacy information. The displays at AES will present data on efficacy throughout totally different focal seizure subtypes and the responder charges related to XCOPRI. 

“We look ahead to presenting information from our scientific trial program to supply extra data on the long-term use of XCOPRI in adults with partial-onset seizures,” stated Marc Kamin, MD, chief medical officer at SK life science. “We stay dedicated to ongoing analysis and sharing real-world insights to help clinicians who’re evaluating epilepsy remedy choices for his or her sufferers.”

The corporate may also current extra data on XCOPRI’s long-term scientific efficacy and security and illness state administration at a particular scientific exhibit and posters session. Moreover, SK life science will sponsor a product theatre session, “TV Information Anchor, Sarah Carlson’s Remedy Journey with XCOPRI,” the place doctor Michael C. Smith, MD, Director, Part of Scientific Neurophysiology and Epilepsy, Division of Neurological Sciences, Rush Medical School, will present a scientific overview of XCOPRI and focus on the remedy expertise together with his affected person, Sarah Carlson.

To see the SK life science digital sales space at AES, please go to StepIntoXcopri.com. 

XCOPRI Shows at AES 2021 Annual Assembly
*Observe, all displays can be found to AES 2021 registrants here

XCOPRI^® (cenobamate tablets) CV Scientific Exhibit at AES 2021 Annual Assembly

XCOPRI Product Theatre at AES 2021 Annual Assembly

About XCOPRI^® (cenobamate tablets) CV 
Cenobamate is an anti-seizure remedy (ASM) found and developed by SK Biopharmaceuticals and SK life science. Whereas the exact mechanism by which cenobamate exerts its therapeutic impact is unknown, it’s believed to scale back repetitive neuronal firing by inhibiting voltage-gated sodium currents. Additionally it is a constructive allosteric modulator of the γ-aminobutyric acid (GABA_A) ion channel.  

Cenobamate is accepted in america for the remedy of partial-onset seizures in adults and is offered beneath the model identify XCOPRI^® (cenobamate tablets) CV. Cenobamate will be mixed with different ASMs or used alone.  The really helpful preliminary dosage of cenobamate is 12.5 mg once-daily, with titration each two weeks; it’s accessible in six pill strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.

Cenobamate can be accepted within the European Union and the United Kingdom for the adjunctive remedy of focal-onset (partial-onset) seizures with or with out secondary generalization in grownup sufferers with seizures that haven’t been adequately managed regardless of a historical past of remedy with at the very least two anti-epileptic medicinal merchandise and is marketed by Angelini Pharma beneath the model identify ONTOZRY^®.

Moreover, cenobamate is in scientific growth in Asia. Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercialize cenobamate in Japan and within the Better China area, respectively.

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

DO NOT TAKE XCOPRI IF YOU:

• Are allergic to cenobamate or any of the opposite elements in XCOPRI.
• Have a genetic downside (referred to as Familial Quick QT syndrome) that impacts {the electrical} system of the center.

XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Allergic reactions: XCOPRI could cause critical pores and skin rash or different critical allergic reactions which can have an effect on organs and different components of your physique just like the liver or blood cells. Chances are you’ll or might not have a rash with these kinds of reactions. Name your healthcare supplier straight away and go to the closest emergency room if in case you have any of the next: swelling of your face, eyes, lips, or tongue, hassle swallowing or respiration, a pores and skin rash, hives, fever, swollen glands, or sore throat that doesn’t go away or comes and goes, painful sores within the mouth or round your eyes, yellowing of your pores and skin or eyes, uncommon bruising or bleeding, extreme fatigue or weak spot, extreme muscle ache, frequent infections, or infections that don’t go away. Take XCOPRI precisely as your healthcare supplier tells you to take it. It is extremely necessary to extend your dose of XCOPRI slowly, as instructed by your healthcare supplier.

QT shortening: XCOPRI might trigger issues with {the electrical} system of the center (QT shortening). Name your healthcare supplier if in case you have signs of QT shortening together with quick heartbeat (coronary heart palpitations) that final a very long time or fainting.

Suicidal habits and ideation: Antiepileptic medicine, together with XCOPRI, might trigger suicidal ideas or actions in a really small variety of individuals, about 1 in 500. Name your well being care supplier straight away if in case you have any of the next signs, particularly if they’re new, worse, or fear you: ideas about suicide or dying; making an attempt to commit suicide; new or worse melancholy, nervousness, or irritability; feeling agitated or stressed; panic assaults; hassle sleeping (insomnia); appearing aggressive; being offended or violent; appearing on harmful impulses; an excessive improve in exercise and speaking (mania); or different uncommon adjustments in habits or temper.

Nervous system issues: XCOPRI might trigger issues that have an effect on your nervous system. Signs of nervous system issues embrace: dizziness, hassle strolling or with coordination, feeling sleepy and drained, hassle concentrating, remembering, and pondering clearly, and imaginative and prescient issues. Don’t drive, function heavy equipment, or do different harmful actions till you understand how XCOPRI impacts you.

Don’t drink alcohol or take different medicines that may make you sleepy or dizzy whereas taking XCOPRI with out first speaking to your healthcare supplier.

DISCONTINUATION:

Don’t cease taking XCOPRI with out first speaking to your healthcare supplier. Stopping XCOPRI immediately could cause critical issues. Stopping seizure drugs immediately in a affected person who has epilepsy could cause seizures that won’t cease (standing epilepticus).

DRUG INTERACTIONS:

XCOPRI might have an effect on the way in which different medicines work, and different medicines might have an effect on how XCOPRI works. Don’t begin or cease different medicines with out speaking to your healthcare supplier. Inform healthcare suppliers about all of the medicines you are taking, together with prescription and over-the-counter medicines, nutritional vitamins and natural dietary supplements.

PREGNANCY AND LACTATION:

XCOPRI might trigger your contraception drugs to be much less efficient. Discuss to your well being care supplier about one of the best contraception methodology to make use of.

Discuss to your well being care supplier if you’re pregnant or plan to turn out to be pregnant. It’s not identified if XCOPRI will hurt your unborn child. Inform your healthcare supplier straight away for those who turn out to be pregnant whereas taking XCOPRI. You and your healthcare supplier will resolve for those who ought to take XCOPRI while you’re pregnant. When you turn out to be pregnant whereas taking XCOPRI, speak to your healthcare supplier about registering with the North American Antiepileptic Drug (NAAED) Being pregnant Registry. The aim of this registry is to gather details about the security of antiepileptic drugs throughout being pregnant. You’ll be able to enroll on this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org.  

Discuss to your well being care supplier if you’re breastfeeding or plan to breastfeed. It’s not identified if XCOPRI passes into breastmilk. Discuss to your healthcare supplier about one of the simplest ways to feed your child whereas taking XCOPRI.

COMMON SIDE EFFECTS:

The commonest negative effects in sufferers taking XCOPRI embrace dizziness, sleepiness, headache, double imaginative and prescient, and feeling drained.

These are usually not all of the doable negative effects of XCOPRI. Inform your healthcare supplier if in case you have any facet impact that bothers you or that doesn’t go away. For extra data, ask your healthcare supplier or pharmacist. Name your physician for medical recommendation about negative effects. Chances are you’ll report negative effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.  

DRUG ABUSE:

XCOPRI is a federally managed substance (CV) as a result of it may be abused or result in dependence. Preserve XCOPRI in a secure place to forestall misuse and abuse. Promoting or making a gift of XCOPRI might hurt others and is in opposition to the legislation.

INDICATION:

XCOPRI is a prescription drugs used to deal with partial-onset seizures in adults 18 years of age and older. It’s not identified if XCOPRI is secure and efficient in kids beneath 18 years of age.

Please see extra affected person data within the Medication Guide. This data doesn’t take the place of speaking together with your healthcare supplier about your situation or your remedy.

Please see full Prescribing Information.

About Epilepsy  
Epilepsy is the fourth commonest neurological dysfunction. There are roughly 3.4 million individuals dwelling with epilepsy in america, with 150,000 information circumstances annually within the nation.^1,2 Epilepsy is characterised by recurrent, unprovoked seizures. The seizures in epilepsy could also be associated to a mind damage or a household tendency, however typically the trigger is totally unknown. Having seizures and epilepsy can have an effect on one’s security, relationships, work, driving, and way more.^3,4 Individuals with epilepsy are in danger for accidents and different well being issues, together with falling, drowning, melancholy and sudden unexplained demise in epilepsy (SUDEP).^3,4 Regardless of the supply of many antiepileptic therapies, virtually 40 % of individuals with epilepsy are usually not in a position to obtain seizure freedom, which means they’ve epilepsy that continues to be uncontrolled.⁵ 

About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.  
SK Biopharmaceuticals and its U.S. subsidiary SK life science are world pharmaceutical firms centered on the analysis, growth and commercialization of therapies for problems of the central nervous system (CNS). The businesses have a pipeline of eight compounds in growth for the remedy of CNS problems, together with epilepsy. Moreover, SK Biopharmaceuticals is concentrated on the invention of recent therapies in oncology. For extra data, go to SK Biopharmaceuticals’ web site at www.skbp.com/eng and SK life science’s web site at www.SKLifeScienceInc.com.  

Each SK Biopharmaceuticals and SK life science are a part of SK Group, one of many largest conglomerates in Korea. SK Inc., the mother or father firm of SK Biopharmaceuticals, continues to boost its portfolio worth by executing long-term investments with a variety of aggressive subsidiaries in varied enterprise areas, together with prescribed drugs and life science, vitality and chemical compounds, data and telecommunication, and semiconductors. As well as, SK Inc. is concentrated on reinforcing its progress foundations by way of worthwhile and sensible administration based mostly on monetary stability, whereas elevating its enterprise worth by investing in new future progress companies. For extra data, please go to http://hc.sk.co.kr/en/. 

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

References 

1. Epilepsy Basis. Who Will get Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Accessed November 2021.   
2. Epilepsy Basis. Epilepsy Statistics. https://www.epilepsy.com/learn/about-epilepsy-basics/epilepsy-statistics. Accessed November 2021. 
3. Epilepsy Basis. Staying Protected. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed November 2021.   
4. Epilepsy Basis. Challenges with Epilepsy. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed November 2021.   
5. Chen Z, Brodie MJ, Liew D, Kwan P. Remedy outcomes in sufferers with newly recognized epilepsy handled with established and new antiepileptic medicine: a 30-year longitudinal cohort examine. https://www.ncbi.nlm.nih.gov/pubmed/29279892. Revealed on-line December 26, 2017. 

SOURCE SK Life Science, Inc.