First in-depth, 5-year analysis of cognitive and psychiatric antagonistic occasions related to cenobamate in grownup sufferers with uncontrolled partial-onset (focal) seizures taking 1-3 concomitant anti-seizure drugs (ASMs)1
PARAMUS, N.J., March 31, 2022 /PRNewswire/ — SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an progressive world pharmaceutical firm targeted on growing therapies for central nervous system (CNS) problems, will current information from a pooled evaluation from research C013/C017 OLEs and C021 evaluating the cognitive and psychiatric treatment-related antagonistic occasions (TEAEs) throughout adjunctive therapy with anti-seizure medicine (ASM) XCOPRI® (cenobamate tablets) CV on the American Academy of Neurology (AAN) Annual Assembly, held in-person in Seattle April 2–7, 2022.
Within the pooled double-blind research (C013/C017) consisting of 442 cenobamate-treated sufferers, reminiscence impairment occurred in 1.8% of cenobamate-treated sufferers (8/442) in comparison with 0.5% of placebo sufferers (1/216) and confusional state occurred in 2.5% of cenobamate-treated sufferers (11/442) in comparison with not one of the sufferers who got a placebo. Through the five-year interval of the pooled analyses, information was collected from C013/C017 OLEs (ranging from the primary dose of cenobamate, together with the double-blind interval) and the part 3 open-label security research (C021), which offered a complete affected person inhabitants of 1,844 sufferers. Whole cognitive TEAE incidence per patient-year in years one by means of 5, had been 0.0704, 0.0364, 0.0687, 0.0098 and 0.0857, respectively. The entire psychiatric TEAE incidence per patient-year, throughout years one by means of 5 had been 0.1963, 0.1233, 0.1418, 0.0391 and 0.1500, respectively.
“Oftentimes, there could also be important cognitive and behavioral antagonistic occasions related to antiseizure drugs,” stated William E. Rosenfeld, MD, FAAN, FAES, epileptologist/neurologist, principal investigator on the Complete Epilepsy Care Heart for Youngsters and Adults in St. Louis, Missouri and SK life science guide. “The double-blind and long-term security information from this pooled evaluation confirmed that cenobamate had a low incidence of cognitive and psychiatric occasions.”
SK life science is presenting 4 posters and two oral displays at AAN, which can be found here. To see the SK life science digital sales space at AAN, please go to StepIntoXcopri.com.
About Research C021
Research C021 was a big, multi-center, open-label Section 3 research assessing the security of cenobamate as adjunctive remedy in 1,340 adults (18-70 years previous) with uncontrolled focal seizures taking 1-3 anti-seizure drugs (ASMs). The aims of the research included the characterization of the long-term security of cenobamate and to grasp the way to finest add cenobamate to regimens that included phenytoin or phenobarbital. As well as, the research was designed to find out the speed of DRESS in at the least 1,000 sufferers taking cenobamate for at the least 6 months, utilizing a low beginning dose and each different week titration; no instances of DRESS occurred within the research. Cenobamate was initiated at 12.5 mg/day and elevated at 2-week intervals to 25, 50, 100, 150 and 200 mg/day. Additional will increase to 400 mg/day utilizing bi-weekly 50 mg/day increments had been allowed.
About Research C017
Research C017 was a multi-center, double-blind, randomized, placebo-controlled research to judge the security and efficacy of cenobamate 200 mg/day as an adjunctive remedy in adults (18-70 years previous) with uncontrolled focal seizures. Within the research, 437 sufferers had been randomized together with 100 sufferers handled with placebo and 108, 110, and 111 sufferers handled, respectively, with 100 mg, 200 mg, and 400 mg/day of cenobamate. Sufferers included within the research had >8 seizures through the 8-week lengthy baseline interval and had been taking 1-3 ASMs. The open label extension (OLE) of the research enrolled 354 sufferers, together with 265 sufferers initially randomized to cenobamate and 90 sufferers initially randomized to placebo through the double-blind interval. The target of the OLE was to judge long-term efficacy, security and tolerability of cenobamate as an adjunctive therapy.
About Research C013
Research C013 was a multi-center, double-blind, randomized, placebo-controlled research to judge the security and efficacy of cenobamate 200 mg/day as an adjunctive remedy in adults (18-65 years previous) with uncontrolled focal seizures. Within the research, 222 sufferers had been randomized (113 acquired cenobamate and 109 acquired placebo). Sufferers will need to have been taking 1-3 anti-seizure drugs (ASMs) at secure doses for at the least 12 weeks previous to randomization and continued taking concomitant ASMs at secure doses through the double-blind therapy interval. The open label extension (OLE) of the research enrolled 149 sufferers from taking part facilities, together with 76 sufferers initially randomized to cenobamate and 73 sufferers initially randomized to placebo through the double-blind interval. The target of the OLE was to look at long-term security, tolerability, and retention charge of cenobamate as an adjunctive therapy.
About XCOPRI® (cenobamate tablets) CV
Cenobamate is an anti-seizure medicine (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 cut back repetitive neuronal firing by inhibiting voltage-gated sodium currents. It’s also a constructive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.
Cenobamate is accepted in the USA for the therapy of partial-onset seizures in adults and is accessible beneath the model title XCOPRI® (cenobamate tablets) CV. Cenobamate could be mixed with different ASMs or used alone. The beneficial 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 also be accepted within the European Union and the UK for the adjunctive therapy 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 therapy with at the least two anti-epileptic medicinal merchandise and is marketed by Angelini Pharma beneath the model title 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 Larger China area, respectively. SK Biopharmaceuticals has not too long ago entered into an unique licensing settlement with Endo for cenobamate in Canada.
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 (known as Familial Brief QT syndrome) that impacts {the electrical} system of the center.
XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
Allergic reactions: XCOPRI may cause severe pores and skin rash or different severe allergic reactions which can have an effect on organs and different elements of your physique just like the liver or blood cells. You might or might not have a rash with some of these reactions. Name your healthcare supplier immediately and go to the closest emergency room when you have any of the next: swelling of your face, eyes, lips, or tongue, bother 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 point, 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 rather essential 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 when 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 medication, 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 immediately when 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 despair, anxiousness, or irritability; feeling agitated or stressed; panic assaults; bother sleeping (insomnia); performing aggressive; being indignant or violent; performing on harmful impulses; an excessive enhance in exercise and speaking (mania); or different uncommon modifications in habits or temper.
Nervous system issues: XCOPRI might trigger issues that have an effect on your nervous system. Signs of nervous system issues embody: dizziness, bother strolling or with coordination, feeling sleepy and drained, bother concentrating, remembering, and considering 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 may cause severe issues. Stopping seizure drugs immediately in a affected person who has epilepsy may 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’re 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. Speak to your well being care supplier about the perfect contraception methodology to make use of.
Speak to your well being care supplier in case you are pregnant or plan to change into pregnant. It’s not recognized if XCOPRI will hurt your unborn child. Inform your healthcare supplier immediately for those who change into pregnant whereas taking XCOPRI. You and your healthcare supplier will resolve for those who ought to take XCOPRI while you’re pregnant. When you change into 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.
Speak to your well being care supplier in case you are breastfeeding or plan to breastfeed. It’s not recognized if XCOPRI passes into breastmilk. Speak to your healthcare supplier about the easiest way to feed your child whereas taking XCOPRI.
COMMON SIDE EFFECTS:
The most typical unwanted side effects in sufferers taking XCOPRI embody dizziness, sleepiness, headache, double imaginative and prescient, and feeling drained.
These aren’t all of the doable unwanted side effects of XCOPRI. Inform your healthcare supplier when you have any aspect impact that bothers you or that doesn’t go away. For extra info, ask your healthcare supplier or pharmacist. Name your physician for medical recommendation about unwanted side effects. You might report unwanted side 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. Maintain XCOPRI in a protected place to forestall misuse and abuse. Promoting or giving freely XCOPRI might hurt others and is in opposition to the regulation.
INDICATION:
XCOPRI is a prescription drugs used to deal with partial-onset seizures in adults 18 years of age and older. It’s not recognized if XCOPRI is protected and efficient in youngsters beneath 18 years of age.
Please see further affected person info within the Medication Guide. This info doesn’t take the place of speaking along with your healthcare supplier about your situation or your therapy.
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 the USA, with 150,000 information instances annually within the nation.2,3 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 far more. 4,5 Individuals with epilepsy are in danger for accidents and different well being problems, together with falling, drowning, despair and sudden unexplained demise in epilepsy (SUDEP).4,5 Regardless of the supply of many antiepileptic therapies, virtually 40 % of individuals with epilepsy aren’t in a position to obtain seizure freedom, which means they’ve epilepsy that is still uncontrolled.6
About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.
SK Biopharmaceuticals and its U.S. subsidiary SK life science are pharmaceutical firms targeted on the analysis, growth and commercialization of therapies for problems of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a analysis heart to start their enlargement into oncology by means of analysis and growth efforts. The businesses have a pipeline of eight compounds in growth in each CNS problems and oncology. Moreover, SK Biopharmaceuticals is targeted on the invention of recent therapies in oncology. For extra info, 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 guardian firm of SK Biopharmaceuticals, continues to boost its portfolio worth by executing long-term investments with quite a few aggressive subsidiaries in varied enterprise areas, together with prescription drugs and life science, vitality and chemical substances, info and telecommunication, and semiconductors. As well as, SK Inc. is targeted on reinforcing its progress foundations by means of worthwhile and sensible administration based mostly on monetary stability, whereas elevating its enterprise worth by investing in new future progress companies. For extra info, please go to http://hc.sk.co.kr/en/.
XCOPRI® and ONTOZRY® are registered logos of SK Biopharmaceuticals Co., Ltd.
Media Inquiries
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References
- Poster Session 13.005: Cognitive and Psychiatric Opposed Occasions Throughout Adjunctive Cenobamate Therapy in Section 2 and Section 3 Scientific Research– Krauss et al.
- Epilepsy Basis. Who Will get Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Accessed March 2022.
- Epilepsy Basis. Epilepsy Statistics. https://www.epilepsy.com/learn/about-epilepsy-basics/epilepsy-statistics. Accessed March 2022.
- Epilepsy Basis. Staying Secure. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed March 2022.
- Epilepsy Basis. Challenges with Epilepsy. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed March 2022.
- Chen Z, Brodie MJ, Liew D, Kwan P. Therapy outcomes in sufferers with newly recognized epilepsy handled with established and new antiepileptic medication: a 30-year longitudinal cohort research. https://www.ncbi.nlm.nih.gov/pubmed/29279892. Revealed on-line December 26, 2017.
SOURCE SK Life Science, Inc.
