perampanel IV / Eisai, Ligand - LARVOL DELTA

Intravenous perampanel for early post-traumatic seizure prophylaxis across a wide range of traumatic brain injury severity: Potential for low incidence and favorable outcomes in a retrospective cohort. (PubMed, Brain Spine) - "Intravenous PER within 12 h of TBI was associated with low EPTS incidence, favorable outcomes, and few adverse events. Given the retrospective, single-arm design and modest sample size, these preliminary, hypothesis-generating findings warrant evaluation in the ongoing PEACE-TBI trial."

Journal • Retrospective data • CNS Disorders • Epilepsy • Psychiatry • Vascular Neurology

Real-world clinical experience with intravenous perampanel in Japanese patients at perceived high risk for early postoperative or acute symptomatic seizures: A single-center retrospective observational study. (PubMed, Epilepsy Behav) - "This retrospective observational study suggests feasibility and acceptable tolerability of PER-IV; however, preventive effects cannot be determined in this uncontrolled study without systematic EEG monitoring. PER-IV is a feasible and well-tolerated option in patients at increased risk of early postoperative or acute symptomatic seizures who are temporarily unable to take oral antiseizure medications, particularly during the perioperative or acute care period. Given the descriptive nature of this study, the absence of a control group, and potential selection bias, these findings should be interpreted cautiously."

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

Single-Dose Intraoperative Perampanel Infusion During Awake Glioma Surgery for Potential Prophylaxis of Intraoperative and Early Postoperative Seizures: A Case Report and Literature Review. (PubMed, Cureus) - "In this report, we present the first documented case of single-dose intravenous perampanel administration for potential seizure prophylaxis in awake glioma surgery. Its rapid therapeutic onset and sustained efficacy suggest potential utility for seizure prophylaxis in awake glioma surgery. However, further studies with larger patient cohorts are warranted to validate efficacy and establish optimal dosing strategies."

Journal • Brain Cancer • CNS Disorders • Epilepsy • Glioma • Oncology • Solid Tumor

Preliminary Safety Study of a Single-dose Perampanel Drip Infusion in Brain Tumor Patients to Prevent Early Postoperative Seizures: The poSTOP Seizure-1 SF Study. (PubMed, Neurol Med Chir (Tokyo)) - "Intravenous perampanel hydrate appears safe and well tolerated in the perioperative setting and may effectively prevent early postoperative seizures. Further studies are planned to evaluate its efficacy in larger patient cohorts."

Journal • Anesthesia • Brain Cancer • CNS Disorders • Epilepsy • Hematological Disorders • Oncology • Solid Tumor

Intravenous perampanel in clinical practice: A multicenter prospective registry study. (PubMed, Seizure) - "This large multicenter prospective registry demonstrates that IV-PER can be safely used for seizure management during the 7-day acute phase in real-world clinical settings."

Journal • Brain Cancer • Cardiovascular • CNS Disorders • Epilepsy • Heart Failure • Hematological Disorders • Oncology • Solid Tumor • Vascular Neurology

The First Case of a Single-Dose, Intravenous Perampanel Administration for Early Postoperative Seizure Prophylaxis. (PubMed, Clin Case Rep) - "Perampanel has an extended serum half-life plus a rapid onset of action. The intravenous form of perampanel was first launched in Japan, and it may be an option for EPS prevention in brain surgery."

Journal • Brain Cancer • CNS Disorders • Epilepsy • Glioblastoma • Oncology • Solid Tumor

Intravenous perampanel as an alternative to the oral formulations in Japanese patients with epilepsy. (PubMed, Epilepsia Open) - P1, P2 | "These results support that 30-minute IV perampanel may be a potential short-term alternative to oral formulations for patients with epilepsy."

Journal • CNS Disorders • Epilepsy

Intravenous Perampanel as an Interchangeable Alternative to Oral Perampanel: A Randomized, Crossover, Phase I Pharmacokinetic and Safety Study. (PubMed, Clin Pharmacol Drug Dev) - P1 | "The IV perampanel safety profile was similar to that of oral perampanel without new safety concerns. Perampanel IV infusions may be a suitable temporary alternative to oral perampanel for treatment maintenance and/or initiation."

Journal • P1 data • PK/PD data • CNS Disorders • Epilepsy

[VIRTUAL] Rapid Attainment of Therapeutic Plasma Concentrations Following Intravenous Perampanel Administration with Loading Dose (AES 2020) - "Based on PK simulations, perampanel IV loading doses of 4 or 5 times that of the intended oral dose are expected to lead to rapid attainment of therapeutic plasma concentrations, similar to that at steady-state with oral dosing. Although the maximum dose of perampanel is 12 mg/day, safety data indicate that single oral doses of up to perampanel 36 mg are well-tolerated. Funding: Eisai Inc."

CNS Disorders • Epilepsy

[VIRTUAL] Perampanel Intravenous Formulation as an Interchangeable Alternative to Oral Tablet Administration for the Treatment of Epilepsy (AES 2020) - P1 | "Modeling and simulation analyses support the interchangeability of perampanel IV 90-, 60- and 30-min infusions and oral dosing for temporary use in patients receiving stable doses of maintenance therapy. Whilst Cmax was slightly higher after treatment initiation with 2-mg perampanel IV vs oral dosing, this difference is not considered clinically significant as 2-mg starting doses are sub-therapeutic. The safety profile of perampanel IV infusions was similar to oral tablets."

CNS Disorders • Epilepsy

A Study of Intravenous Perampanel in Japanese Participants With Epilepsy (clinicaltrials.gov) - P2; N=21; Completed; Sponsor: Eisai Inc.; Recruiting ➔ Completed

Clinical • Trial completion

Pharmacokinetic (PK) Assessment of Perampanel Intravenous (IV) Formulation as a Bioequivalent Alternative to Oral Tablet Administration (AAN 2019) - "Perampanel IV infusions are a suitable alternative to oral tablets for treatment maintenance or initiation when oral dosing is temporarily not feasible. Funding: Eisai Inc."

PK/PD data