Sesquient Approved for Treatment of Status Epilepticus in Adults, Children

John Sedor, CEO, Sedor Pharmaceuticals

The FDA has approved fosphenytoin sodium for injection (Sesquient) from Sedor Pharmaceuticals for treatment of status epilepticus (SE) in adults and children.¹

Currently, the injectable is the only room temperature-stable fosphenytoin approved for treatment of SE. Cerebryx is another fosphenytoin currently used to treat SE, but it requires refrigerated storage in the pharmacy which can create a delay between symptom onset and treatment.¹ Neurocritical Care Society guidelines state that irreversible brain damage or death may occur if seizures are not stopped within 60 minutes of onset.²

“Time to treat and cessation of a status epilepticus seizure is critical to avoiding irreversible morbidity and associated hospital costs, and mortality,” Barry Frankel, MBA, chief business officer and co-founder, Sedor, stated in an earlier press release.³ “[Sesquient] will offer healthcare providers the only room temperature, readily available fosphenytoin and, as such, an important alternative when treating this critical condition.” 

READ MORE: Midazolam for Status Epilepticus Underutilized in EMS Setting Despite High Efficacy

The treatment allows for point-of-care storage and administration in first responder vehicles, emergency rooms, long-term care facilities, and others critical areas where prompt care is needed.

“At some hospitals, it can take up to 30 minutes to get a status epilepticus drug from the pharmacy to the point of care in the ER to treat a patient. Sesquient...could help health care providers quickly treat status epilepticus patients and potentially reduce hospital costs associated with this condition,” Frankel said.³

Although benzodiazepines are considered first-line treatment for SE, up to 33% of patients experience benzodiazepine-refractory SE, for which fosphenytoin is the only other FDA-approved treatment. NeurologyLive previously covered research from Jaideep Kapur, MB, BS, PhD, et al. that showed that levetiracetam and valproate are equally effective for treatment of SE despite not being indicated by the FDA for this purpose. All told, cessation of SE and improved responsiveness within 60 minutes of administration occurred in 47% of patients in the levetiracetam group (95% CI, 39–55), 45% in the fosphenytoin group (95% CI, 36–54), and 46% in the valproate group (95% CI, 38–55), with no significantly different results between groups and no variation in serious adverse events observed among the 3 drugs.⁴

John Sedor, chairman, CEO, and co-founder, Sedor, commented on the next steps for the company, saying “While Sesquient is available in pre-filled liquid vials, this is a multi-dosage platform, which we believe will be followed by a pre-filled [intravenous] bag.”¹

SE has been the target of much recent research. In the case of super-refractory SE (SRSE), in which patients do not respond to treatment with benzodiazepine nor fosphenytoin, a recent study demonstrated the efficacy of ketamine infusion in decreasing seizure burden. Jan Claassen, MD, FNCS, associate professor of neurology, director, clinical care neurology, Columbia University, and colleagues found that 79% (n = 54) of patients achieved at least a 50% decrease in seizure burden and 65% (n = 44) had complete seizure cessation after stopping ketamine treatment when monitoring with scalp electroencephalogram.⁵ 

As well, Jessica R. Fesler, MD, from the Cleveland Clinic Epilepsy Center, and colleagues reviewed the use of a pocket card algorithm to aid in the treatment of all kinds of SE and concluded that the pocket card is an efficient and effective educational tool for clinicians on care teams. These cards are updated with the latest care guidelines and include information to ensure the accurate dosing and timing of treatments like benzodiazepine.⁶

REFERENCES
1. Sedor Pharmaceuticals receives FDA approval for Sesquient (fosphenytoin sodium) for the treatment of status epilepticus in adult and pediatric patients. News release. Sedor Pharmaceuticals. November 9, 2020. Accessed November 9, 2020. https://www.biospace.com/article/releases/sedor-pharmaceuticals-receives-fda-approval-for-sesquient-fosphenytoin-sodium-for-the-treatment-of-status-epilepticus-in-adult-and-pediatric-patients
2. Brophy GM, Bell R, Claassen J, et al. Guidelines for the evaluation and management of status epilepticus. Neurocrit Care. 2012;17(1):3-23. doi: 10.1007/s12028-012-9695-z
3. Sedor Pharmaceuticals files NDA for CE-fosphenytoin for status epilepticus. News release. Sedor Pharmaceuticals. May 30, 2018. Accessed November 9, 2020. https://www.drugs.com/nda/sesquient_180530.html
4. Kapur J, Elm J, Chamberlain JM, et al. Randomized trial of three anticonvulsant medications for status epilepticus. N Engl J Med. 2019;381:2103-2113. doi: 10.1056/NEJMoa1905795
5. Alkhachroum A, Der-Nigoghossian CA, Mathews E, et. al. Ketamine to treat super-refractory status epilepticus. Neurology. Published online September 1, 2020. doi: 10.1212/WNL.0000000000010611
6. Fesler JR, Belcher AE, Moosa AN, et. al. The efficacy and use of a pocket card algorithm in status epilepticus treatment. Neurology. Published online August 28, 2020. doi: 10.1212/CPJ.0000000000000922