Room Temperature Stable Fosphenytoin Gets FDA Approval

The Food and Drug Administration (FDA) has approved Sesquient™ (fosphenytoin sodium injection; Sedor Pharmaceuticals) for the treatment of status epilepticus in adult and pediatric patients.

Sesquient is indicated for the treatment of generalized tonic-clonic status epilepticus in adults; for the prevention and treatment of seizures occurring during neurosurgery in adults; and for short-term substitution for oral phenytoin in patients aged 2 years and older, when oral administration is not possible. 

The product is a ready-to-dilute, room temperature stable formulation of fosphenytoin for intravenous (IV) injection, which allows for point-of-care storage in emergency rooms, intensive care units, first responder vehicles, and long-term care facilities. Approval of Sesquient was based on bioavailability studies comparing it to another IV fosphenytoin that does not contain betadex sulfobutyl ether sodium; this ingredient limits the use of Sesquient in the pediatric population to non-urgent loading dosing and short-term maintenance dosing as replacement for oral phenytoin in patients older than 2 years.

Sesquient will be supplied as 500mg and 100mg of phenytoin sodium equivalents in 10mL and 2mL single-dose vials, respectively.

“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,” stated Barry Frankel, Chief Business Officer and co-founder of Sedor, “Sesquient, the first and only FDA-approved room temperature stable fosphenytoin, could help health care providers quickly treat status epilepticus patients and potentially reduce hospital costs associated with this condition.”

Cerebyx (fosphenytoin sodium injection; Pfizer) is currently approved for similar indications, but requires refrigeration. 

For more information visit sedorpharmaceuticals.com.

References

1. Sedor pharmaceuticals receives FDA approval for Sesquient™ (fosphenytoin sodium) for the treatment of status epilepticus in adult and pediatric patients. [press release]. Paoli, PA: Sedor Pharmaceuticals; November 9, 2020. 
2. Sesquient [package insert]. Paoli, PA: Sedor Pharmaceuticals; 2020.