Xcopri (cenobamate) / SK Bio, Angelini Group, Endo, Ono Pharma, Eurofarma - LARVOL DELTA

Increase of Brivaracetam serum concentration with introduction of Cenobamate. (PubMed, Front Pharmacol) - "New introduction of Cenobamate to a pre-existing antiseizure regimen containing Brivaracetam leads to considerably increases in Brivaracetam, probably related to inhibition of CYP2C19. This needs to be taken into account when interpreting changes in treatment efficacy, but also when relating potential adverse effects to baseline vs. newly introduced treatment."

Journal • CNS Disorders • Epilepsy • CYP2C19

Cenobamate as add-on treatment in ultra-refractory focal epilepsy: Real-world results from The Danish Epilepsy Centre, Dianalund, Denmark. (PubMed, Neurol Sci) - "Our study underlines the usefulness of cenobamate in treating patients with ultra-refractory epilepsy and indicates its long-term effectiveness in real-world clinical practice."

Journal • Real-world evidence • CNS Disorders • Epilepsy

Cenobamate: A Review in Focal-Onset Seizures. (PubMed, CNS Drugs) - "The effectiveness and adverse events of cenobamate in real-world studies were consistent with those seen in the clinical studies. Thus, cenobamate continues to represent a useful adjunctive treatment option in adults with uncontrolled focal-onset seizures."

Journal • CNS Disorders • Epilepsy • Fatigue

Paladin Pharma and the pan-Canadian Pharmaceutical Alliance (pCPA) Successfully Complete Negotiations for Public Funding of XCOPRI (cenobamate tablets) (Canada Newswire) - "Paladin Pharma is pleased to announce the successful completion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for the public funding of XCOPRI (cenobamate tablets) as adjunctive therapy in the management of focal seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy."

Financing • Epilepsy

REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

HEOR • New trial • CNS Disorders • Epilepsy

A Case of Aicardi Syndrome with Positive Outcomes Following Hemispherectomy (P10-9.015). (PubMed, Neurology) - "EEG showed hypsarrhythmia responsive to vigabatrin...Patient trialed on carbamazepine, oxcarbazepine, divalproex, levetiracetam, phenobarbital, phenytoin, clobazam, and topiramate...Medication regimen consisted of oxcarbazepine 900 mg BID, brivaracetam 150 mg BID, cenobamate 200 mg daily, and cannabidiol 2 mL/kg BID...In light of dramatic improvement in seizure frequency and severity, she weaned off multiple antiepileptic medications, now on cenobamate 300 mg and klonopin 0.5 mg daily...Dr. Proteasa has nothing to disclose."

Journal • Cardiovascular • CNS Disorders • Epilepsy • Genetic Disorders • Rare Diseases

Cenobamate Monotherapy for Focal Epilepsy: A Single-Center Retrospective Study. (PubMed, Neurol Clin Pract) - "The mean seizure frequency on cenobamate was reduced from 4.3 to 0.7 per month; the responder rate (50% reduction in seizure frequency) was achieved at 77%, and 55% of the patients remained seizure-free during the 12-month observation period. Cenobamate monotherapy was found to significantly reduce seizure frequency and achieve high seizure freedom rates and was well tolerated in patients with focal epilepsy, highlighting its promise as an emerging alternative for patients with refractory focal epilepsy."

Journal • Monotherapy • Retrospective data • CNS Disorders • Epilepsy

Cenobamate in developmental and epileptic encephalopathies and generalized epilepsies: A case report on epilepsy with myoclonic-atonic seizures and systematic review of current evidence. (PubMed, Seizure) - "CNB demonstrates potential efficacy in managing seizures across drug-resistant epilepsy syndromes, extending its established use beyond FE. Further prospective trials are needed to validate these findings and optimize dosing strategies."

Journal • Review • Anesthesia • CNS Disorders • Epilepsy • Fatigue

Cenobamate add-on therapy for drug-resistant focal seizures: a systematic review and meta-analysis. (PubMed, Expert Rev Neurother) - "The results indicated that the 50%responder rate (RR 1.77; 95% CI: 1.28 to 2.44, p = 0.000551, I² = 70.3%) andseizure freedom (RR of 3.09; 95% CI: 1.91 to 5.00, p = 0.000004, I² = 8.7%)were significantly higher in this group. In this meta-analysis of four studies, CNB as an add-ontherapy significantly reduced seizure frequency in patients with uncontrolledfocal seizures, making it a promising option for improved seizure control andquality of life."

Journal • Retrospective data • Review • CNS Disorders • Epilepsy

Sodium channel blockers for the treatment of focal epilepsy: A Chinese expert consensus. (PubMed, Seizure) - "This is a Chinese expert consensus on the use of SCBs in focal epilepsy developed using the modified Delphi method. These recommendations can help clinicians in their practice and guide future research."

Journal • Review • CNS Disorders • Epilepsy

Real-world effectiveness and tolerability of cenobamate in drug-resistant epilepsy: A retrospective analysis of the patients included into the Early Access Programs (EAP) in Germany, France, and United Kingdom. (PubMed, Epilepsia Open) - "This study involved patients with drug-resistant epilepsy, who had continued seizures despite using at least two antiseizure medications (ASMs). Patients received cenobamate (Ontozry) as epilepsy treatment during the Early Access Program (EAP) in France, Germany, and the United Kingdom. An EAP allows patients to receive promising new drugs under clinical supervision before they are commercially available. After 6 months from cenobamate start, 49.3% of patients had their seizures cut by half or more, and 13.6% became seizure-free. A total of 30.9% of patients had an undesirable reaction to cenobamate, mostly mild-to-moderate and resolved; the most frequent were asthenia, dizziness, and somnolence."

Journal • Real-world evidence • Retrospective data • CNS Disorders • Epilepsy

Seizure freedom and reducing the risk of sudden unexpected death in patients with focal epilepsy treated with cenobamate or other antiseizure medications. (PubMed, Epilepsia) - "As FBTCS are associated with the highest risk of death, prevention of this seizure type is especially important, and physicians should continue to try new therapies to prevent these seizures. A shared decision-making model should be used when interacting with patients and their care providers to achieve and maintain seizure control and maximize treatment outcomes."

Journal • Review • CNS Disorders • Epilepsy

Do the third-generation antiseizure medications provide the "magic bullet" for drug-resistant epilepsy? Focus on cenobamate. (PubMed, Epilepsia) - No abstract available

Journal • CNS Disorders • Epilepsy

Cenobamate efficacy in specific populations. (PubMed, Epilepsia) - "Rare developmental epileptic encephalopathies such as Lennox-Gastaut syndrome and Dravet syndrome are typically diagnosed in childhood and have proven to be refractory to treatment and to have high mortality rates. Here, we provide an overview of ASM use in patients with refractory epilepsy, in older patients, and in pediatric patients, with a focus on the efficacy outcomes, safety, and tolerability observed with a newer ASM, cenobamate."

Journal • Review • CNS Disorders • Epilepsy • Pediatrics

Improving the tolerability of antiseizure medications: When and how to use cenobamate and other new antiseizure medications. (PubMed, Epilepsia) - "With newer effective treatments (e.g., lacosamide, eslicarbazepine, perampanel, brivaracetam, and most recently, cenobamate), the risk of AEs may be minimized by proactively adjusting concomitant ASMs that have known pharmacokinetic and/or pharmacodynamic drug interactions. Strategies to improve the tolerability of effective ASMs further, including earlier add-on therapy and transition to, or initial, monotherapy should be investigated. Ongoing clinical studies in children and people with generalized tonic-clonic seizures of the most recent ASM addition, cenobamate, will further inform the safety profile of cenobamate and its potential utility as a broad-spectrum treatment option."

Journal • Review • CNS Disorders • Epilepsy

Epilepsy medication management: Addressing common treatment barriers to adopting cenobamate and other new antiseizure medications. (PubMed, Epilepsia) - "Third-generation ASMs, such as lacosamide, eslicarbazepine, perampanel, and brivaracetam, have demonstrated good efficacy in terms of reductions in the frequency of focal seizures. These include treatment complacency, inadequate trial of new adjunctive therapies ("last in, first out"), pitfalls of rational polytherapy, and restricting the use of newer drugs. Although treatment must always be tailored to the specific patient, clinicians should consider the potential benefits of newer therapies and continue to reassess and optimize ASM treatment to achieve the best outcomes for their patients."

Journal • Review • CNS Disorders • Epilepsy

Cenobamate modulates EEG cortical activity and connectivity in individuals with drug-resistant epilepsy: a pharmaco-EEG study. (PubMed, Front Neurol) - "Cenobamate induces an EEG connectivity modulation that is highly associated with cenobamate clinical response. Connectivity analysis of pharmaco-EEG can provide new hints toward the development of innovative biomarkers and precision medicine in individuals with epilepsy."

Journal • CNS Disorders • Epilepsy

Effectiveness and safety of adjunctive cenobamate in people with focal-onset epilepsy: Interim results after 24-week observational period from the BLESS study. (PubMed, Epilepsia) - P | "Cenobamate was effective in reducing seizure frequency in a real-world setting and showed a manageable safety profile. The treatment with cenobamate also reduced the burden of concomitant ASMs in both early and late users."

Journal • CNS Disorders • Epilepsy • Otorhinolaryngology

Clarification of the Mechanism of Action of Cenobamate (AAN 2025) - "Cenobamate's selectivity for the INaP over INaT likely represents action on the NaV1.6 channel over the NaV1.1 channel and is a feature not shared by traditional antiseizure medications like phenytoin or carbamazepine.Cenobamate selectively inhibits INaP, which may involve preferential action at NaV1.6 over NaV1.1 channels, while sparing INaT. Cenobamate selectively inhibits INaP, which may involve preferential action at NaV1.6 over NaV1.1 channels, while sparing INaT. Sparing the INaT is critical for preserving the inhibitory activity of fast-spiking interneurons. This effect on INaP may be enhanced by cenobamate's positive allosteric modulation of tonic (extrasynaptic) GABAA receptors."

CNS Disorders • Epilepsy • NAV1

Long Term Outcomes with Cenobamate Use in an Epilepsy Clinic (AAN 2025) - "Cenobamate shows good efficacy and retention over extended follow-up in patients with refractory epilepsy. Seizure freedom rates are much higher than historically expected with medical management in this population. Many patients discontinued due to fatigue, sleepiness, and dizziness."

CNS Disorders • Epilepsy • Fatigue

Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (AAN 2025) - P3 | "Statistically significant reductions in focal seizure frequency were observed early during cenobamate titration (at Week 5-6). Adjunctive cenobamate was generally well-tolerated."

Clinical • CNS Disorders • Epilepsy

Efficacy of Adjunctive Cenobamate by Focal Seizure Subtypes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (AAN 2025) - P3 | "This study supports the efficacy and safety profile of cenobamate using the approved titration regimen in a multinational Asian population. Statistically significant seizure reductions occurred across all assessed seizure subtypes."

Clinical • CNS Disorders • Epilepsy

Cenobamate Add-On Therapy for Drug-Resistant Focal Seizures: A Systematic Review and Meta-Analysis (AAN 2025) - "In this meta-analysis of four studies, CNB as an add-on therapy significantly reduced seizure frequency in patients with drug-resistant focal seizures, making it a promising option for improved seizure control and quality of life."

Retrospective data • Review • CNS Disorders • Epilepsy • Ophthalmology • Otorhinolaryngology

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Cenobamate in Asian Patients With Focal Seizures, With Optional Open-Label Extension (AAN 2025) - P3 | "This study supports the efficacy and safety profile of cenobamate using the approved titration regimen in a multinational Asian population. Adjunctive cenobamate 100, 200, and 400 mg significantly reduced focal seizure frequency vs placebo and was generally well tolerated."

Clinical • CNS Disorders • Epilepsy

Adjunctive Cenobamate for the Treatment of Primary Generalized Tonic-Clonic Seizures in Adults and Adolescents: Design of a Phase 3 Study With Open-Label Extension (AAN 2025) - P3 | "Study C025 will be the first adequate and well-controlled trial that assesses the effect of cenobamate on PGTC seizures. These results will provide evidence about the broad-spectrum potential of cenobamate."

Clinical • P3 data • CNS Disorders • Epilepsy