FDA Approves Sesquient
FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients
PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced 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.
“Status epilepticus is associated with irreversible neurologic damage and death, both of which largely depend on the seizure duration before initial treatment,” stated Barry Frankel, Chief Business Officer and co-founder of Sedor. “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 – 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.”
“This is an important milestone for Sedor Pharmaceuticals and opens a significant global market for the company. As our first NDA approved drug, Sesquient validates our business model of efficient development of critical care hospital injectable products,” added John Sedor, Chairman, CEO and co-founder of Sedor. Mr. Sedor added “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 IV bag. With this achievement completed, we are turning our focus to the development of our second product, Meloxicam for injection solubilized with betadex sulfobutyl ether sodium, for the potential treatment of acute post-surgical pain.”
Sedor is actively engaged in discussions to license the rights to Sesquient for North America, Europe, and other territories except for the Peoples Republic of China, where it has already been successfully licensed. Concurrently, Sedor is in discussions on securing capital to retain North American rights and commercialize the product.
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 www.sedorpharmaceuticals.com.
Source: Sedor Pharmaceuticals, LLC
Posted: November 2020
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Sesquient (fosphenytoin sodium) FDA Approval History
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