Sedor Pharmaceuticals, LLC (Sedor) announced on November 9, 2020 that the U.S. Food and Drug Administration (FDA) has approved SESQUIENT (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients.
According to Neurocritical Care Society Guidelines, status epilepticus, which is classified as a single epileptic seizure lasting more than five minutes or two or more seizures within a five-minute period, must be treated quickly since irreversible brain damage or death may result if cessation of seizure is not achieved within 60 minutes of onset. Ready-to-dilute and room temperature stable, SESQUIENT is the only FDA-approved fosphenytoin that allows point-of-care storage, as well as fast and efficient administration in emergency rooms, intensive care units, first responder vehicles, and long-term care facilities, where serial seizures such as status epilepticus are most commonly treated.
About Sedor Pharmaceuticals, LLC
Sedor Pharmaceuticals, LLC identifies, acquires and develops acute care pharmaceutical assets for commercial licensing. The Company is led by Chairman and CEO John Sedor and an experienced team of pharmaceutical professionals, all possessing a proven track record of building pharmaceutical companies and creating shareholder value. The company’s lead product, SESQUIENT, has received FDA approval for the treatment of status epilepticus. The company is preparing to enter Phase I development of its second product, Meloxicam for injection solubilized with betadex sulfobutyl ether sodium, for the potential treatment of acute post-surgical pain. If approved, it could possibly replace or delay the use of IM/IV opioids. Both products were licensed from Ligand Pharmaceuticals.
SESQUIENT™ (fosphenytoin sodium for injection) is the only FDA-approved room-temperature stable formulation of fosphenytoin sodium. It is FDA approved for adult and pediatric use in the U.S. to treat generalized tonic-clonic status epilepticus, the prevention and treatment of seizures occurring during neurosurgery and for substitution short-term use in place of oral phenytoin, when oral phenytoin administration is not possible. More information can be found at http://www.sedorpharmaceuticals.com.