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 US 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.
“We are pleased to see Sedor’s progress with SESQUIENT and today’s FDA approval for another Captisol-based medicine,” said John Higgins, CEO Ligand Pharmaceuticals. “Our partners at Sedor are a dedicated and determined team that has taken Ligand’s promising initial product concept and advanced it to a first regulatory success. Like many other drugs, Captisol plays an important role in the formulation of this drug for IV administration to patients undergoing status epilepticus seizures. This has been an extraordinary year of clinical, regulatory and financial achievements for our Captisol business, and we are proud to see another product advance successfully through the FDA process.”
SESQUIENT (fosphenytoin sodium for injection) is the only US FDA-approved room-temperature stable formulation of fosphenytoin sodium. It is US 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.
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Gilead’s VEKLURY, Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including 37 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.