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.
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.”
For more information visit Sedorpharmaceuticals.com.