Ligand Pharmaceuticals Incorporated announced that its partner Sedor Pharmaceuticals, LLC has received approval from the U.S. Food and Drug Administration (FDA) for SESQUIENT, a Captisol-enabled™ Fosphenytoin (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients.
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. Sedor is actively engaged in discussions to license commercial rights to SESQUIENT for North America, Europe and other territories except for China, where it has already been licensed.
Fosphenytoin will be the 14th drug substance marketed using SBECD to develop a parenteral formulation.
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 www.sedorpharmaceuticals.com.