The New Drug Application (NDA) for IM/IV Captisol-Enabled Fosphenytoin (fosphenytoin sodium and sulfobutylether beta-cyclodextrin sodium for injection; Sedor) has been accepted for review and given a Prescription Drug Fee User Act date of March 22, 2019 by the Food and Drug Administration (FDA).

The product is being reviewed as a treatment for generalized tonic-clonic status epilepticus, for the prevention and treatment of seizures occurring during neurosurgery, as a short-term substitute for oral phenytoin, when oral administration is not possible, and for pediatric use.

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Currently, Cerebyx (fosphenytoin sodium; Pfizer) is indicated for similar indications, but requires refrigeration, unlike this investigational formulation of fosphenytoin. If approved, IM/IV Captisol-Enabled Fosphenytoin would allow for rapid dispensing, reducing the possible risk of delayed treatment.

“It is clear from both US and EU guidelines that time to treat and cessation of a status epilepticus seizure is critical to avoiding the potential for irreversible morbidity and associated hospital costs, and mortality,” said Barry Frankel, CBO and co-founder of Sedor. “CE-Fosphenytoin, if approved by the FDA, will offer healthcare providers the only room temperature readily available fosphenytoin and, as such, an important alternative when treating this critical condition.”

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