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

Cenobamate for Adjunctive Treatment in Adult and Pediatric Patients with Refractory Lennox-Gastaut Syndrome: A Retrospective Chart Review. (PubMed, Neurol Ther) - "This chart review provides promising evidence for the efficacy of CNB in treating LGS. Additional prospective studies will help to clarify CNB's efficacy and safety profile for patients with LGS."

Journal • Retrospective data • CNS Disorders • Epilepsy • Pediatrics

A french real-world experience with cenobamate in patients with drug-resistant focal epilepsy: A retrospective observational study. (PubMed, Epilepsy Behav Rep) - "Cenobamate is an effective and well-tolerated ASM in drug-resistant focal epilepsy and should be tried for highly drug-resistant epilepsy, even if many previous ASM have failed. Moreover, the impressive seizure-free rate leads to introducing cenobamate to all patients before or during the evaluation for surgical candidacy, and in any case before any resective surgery."

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

The Effectiveness of Cenobamate in Patients Treated With Vagus Nerve Stimulation for Drug Resistant Epilepsy. (PubMed, Eur J Neurol) - "For DRE patients treated with VNS who could benefit from further improvement in seizure control, adding CNB is useful. In our cohort, over one-third of patients experienced a meaningful improvement in seizure frequency with this recently marketed ASM."

Journal • Retrospective data • CNS Disorders • Epilepsy • Fatigue

Drug-induced subacute cutaneous lupus erythematous from cenobamate: case presentation and review of the literature. (PubMed, Dermatol Online J) - "The rash was initially treated with topical triamcinolone with improvement at one-month follow-up. Given the worsening rash, positive labs, and cenobamate as the only changed drug several months before initial onset, she was diagnosed with drug-induced subacute cutaneous lupus erythematous and her cenobamate was discontinued. To the best of your knowledge, this is the first reported case of a medication in the carbamate family leading to drug induced subacute cutaneous lupus erythematosus."

Journal • Review • CNS Disorders • Cutaneous Lupus Erythematosus • Dermatitis • Dermatology • Epilepsy • Immunology • Inflammatory Arthritis • Lupus

Budget impact analysis of cenobamate, a novel adjunctive therapy for the treatment of drug resistant focal onset seizures, from the Belgian healthcare payer perspective. (PubMed, J Med Econ) - "The savings at medical cost level fully offset the impact of cenobamate on the drug budget, leading to an overall healthcare budget saving of -€8 105 616 for NIHDI. This favourable outcome is largely due to cenobamate's high efficacy reflected in its high response rate and significant effect on reducing seizure frequency."

HEOR • Journal • CNS Disorders • Epilepsy

Effectiveness and safety of cenobamate in Lennox-Gastaut syndrome: A multicenter real-world study in Spain. (PubMed, Seizure) - "In this study, CNB demonstrated high effectiveness and good tolerability in patients with LGS when administered in adjuvancy in real-world practice after the failure of multiple ASMs. AEs were frequent but mostly mild-to-moderate."

Journal • Real-world evidence • CNS Disorders • Epilepsy

Cenobamate-associated weight loss (Cenobaweight study). (PubMed, Epilepsia) - "A larger than expected number of patients in two centers had significant unintentional weight loss associated with CNB use. In a subset, the effect appeared to be reversible with minor dose reduction, even with severe weight loss. Systematic weight assessment should be considered in all patients on CNB, especially with telehealth. Clinicians should rule out contributing etiologies and consider CNB dose reduction if excessive weight loss occurs."

Journal • CNS Disorders • Epilepsy

The Effects of Cenobamate and Its Dosage on Cognition: A Retrospective Longitudinal Study in 84 Individuals with Epilepsy. (PubMed, CNS Drugs) - "The results of this real-world study investigating objective cognitive performance under CNB suggest possible, partially dose-dependent negative effects of CNB on cognition. Daily CNB doses of ≥ 300 mg were associated with a significant decline in executive functions. Furthermore, a dose-independent negative effect on verbal retention was observed in a subgroup of patients undergoing extensive memory assessment. Given the limitations of retrospective audits, our findings prompt further, larger scope studies to confirm the results. However, a careful balance between seizure control at the lowest CNB dose possible and potential cognitive side effects appears advisable, which requires the implementation of cognitive monitoring in standard care where possible."

Journal • Observational data • Retrospective data • CNS Disorders • Epilepsy

Cenobamate use in pregnancy: A case report. (PubMed, Seizure) - No abstract available

Journal

Potential of cenobamate as a broad-spectrum antiseizure medication. (PubMed, Expert Opin Pharmacother) - "Evidence is accumulating regarding the utility of cenobamate in treating primary generalized tonic-clonic (PGTC) and seizures associated with developmental epileptic encephalopathies such as Lennox-Gastaut syndrome and Dravet syndrome. Results from the ongoing cenobamate trial in patients with idiopathic generalized epilepsy will determine the efficacy of cenobamate for the treatment of PGTC seizures."

Journal • Review • CNS Disorders • Epilepsy

Steps towards seizure freedom with the use of Cenobamate. (PubMed, Epilepsy Behav) - "This is the first real-world data series that compares the use of CNB in two cohorts of a single centre. One year follow-up seizure freedom rates above 20% can be achieved by a proper patient selection, CNB dose increase and ASM dose reduction, which eventually lead to CNB monotherapy in some cases."

Journal • CNS Disorders • Epilepsy

The Development of Synthetic Routes Leading to Pharmaceuticals and the Key Intermediates Using Hydroxynitrile Lyase. (PubMed, J Org Chem) - "In this investigation, we developed several novel synthetic routes using hydroxynitrile lyase (HNL) from Parafontaria laminata (PlamHNL) to synthesize active pharmaceutical ingredients, specifically Cenobamate (Xcopri), Clopidogrel (Plavix), and Mirabegron (Myrbetriq). Our methods demonstrate higher enantioselectivity, improved regioselectivity, and better yields. Notably, both Xcopri and Clopidogrel are produced from a common intermediate, (R)-methyl-2-chloro mandelate."

Journal

Cenobamate in Real-Word Scenario: Results on Efficacy, Side Effects, and Retention Rate in a Single Center Retrospective Study. (PubMed, Brain Behav) - "In this large cohort of 262 PWE, CNB proved very efficient with a high retention rate over one year. Co-medication with perampanel or GABA receptor modulators was linked to seizure-freedom. The overall positive impression of CNB is further supported."

Adverse events • Journal • Retrospective data • CNS Disorders • Epilepsy

Effectiveness and safety of single anti-seizure medication as adjunctive therapy for drug-resistant focal epilepsy based on network meta-analysis. (PubMed, Front Pharmacol) - "Compared to placebo, the following ASMs demonstrated statistically significant effectiveness in achieving a 50% response rate: brivaracetam (RR = 2.07, 95% CI: 1.53-2.81), cenobamate (RR = 2.12, 95% CI: 1.56-2.88), eslicarbazepine acetate (RR = 1.95, 95% CI: 1.41-2.70), gabapentin (RR = 2.30, 95% CI: 1.76-3.02), lacosamide (RR = 2.22, 95% CI: 1.47-3.35), lamotrigine (RR = 1.55, 95% CI: 1.00-2.40), levetiracetam (RR = 2.43, 95% CI: 1.88-3.15), oxcarbazepine (RR = 3.03, 95% CI: 2.08-4.40), perampanel (RR = 1.72, 95% CI: 1.21-2.44), pregabalin (RR = 2.06, 95% CI: 1.70-2.50), rufinamide (RR = 2.28, 95% CI: 1.20-4.31), tiagabine (RR = 4.07, 95% CI: 2.03-8.18), topiramate (RR = 3.10, 95% CI: 2.44-3.95), vigabatrin (RR = 2.34, 95% CI: 1.58-3.46), and zonisamide (RR = 2.40, 95% CI: 1.76-3.27). Additionally, comprehensive safety data for tiagabine and levetiracetam are lacking, necessitating further research. Larger studies are required to solidify these findings and better..."

Journal • Retrospective data • Review • Ataxia • CNS Disorders • Epilepsy • Fatigue • Movement Disorders • Pain

Efficacy and safety of Cenobamate: a multicenter, retrospective evaluation of real-world clinical practice. (PubMed, Seizure) - "Cenobamate is a highly effective and well-tolerated ASM for patients with DRE, offering significant clinical benefits, including improved seizure control and reduced polytherapy."

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

Cost-effectiveness of cenobamate as a therapeutic alternative for the treatment of focal epilepsy in adults with inadequate seizure control. (PubMed, Glob Reg Health Technol Assess) - "Cenobamate represents a more effective and economically advantageous treatment for patients with FOS when compared to brivaracetam, lacosamide, eslicarbazepine acetate, and perampanel. Its capacity to improve seizure control and enhance the quality of life, alongside favorable economic implications, underscores its position as the preferred therapeutic option in this patient population."

HEOR • Journal • CNS Disorders • Epilepsy

Cenobamate and pregnancy: A-single level 4 epilepsy center experience. (PubMed, Epilepsy Behav) - "While our report remains anecdotal and preliminary given the very small sample size, we underscore the importance of pre-conceptual counseling in FCAWE to prevent unintended pregnancies and undesired outcomes, particularly when using ASM with limited data regarding teratogenicity. We also shed light on drug level monitoring during pregnancy."

Journal • CNS Disorders • Developmental Disorders • Epilepsy

Lack of effectiveness and seizure worsening with cenobamate in pediatric patients with Dravet syndrome. (PubMed, Epilepsia) - "Our findings suggest that cenobamate lacks effectiveness in pediatric DS and may exacerbate seizures in some cases. These results highlight the need for age-specific approaches in treatment decisions for genetic epilepsies."

Journal • Anorexia • CNS Disorders • Epilepsy • Pediatrics

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