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Cerebyx

Fosphenytoin (Cerebyx®, Parke-Davis; Prodilantin®, Pfizer Holding France) is a water-soluble phenytoin prodrug used only in hospitals for the treatment of epileptic seizures. more...

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On 18 November 2004, Sicor Pharms received a tentative approval letter from the United States Food and Drug Administration for a generic version of fosphenytoin.

Uses

Approved

Fosphenytoin is approved in the United States for the short term (five days or less) treatment of epilepsy when more widely used means of phenytoin administration are not possible or are ill-advised, such as endotracheal intubation, status epilepticus or some other type of repeated seizures; vomiting, and/or the patient is unalert or not awake or both.

Unapproved/Off-label/Investigational

In April of 2003, Applebaum and colleagues at the Ben Gurion University of the Negev in Beersheva reported that even though anticonvulsants are often very effective in mania, and acute mania requires rapid treatment, fosphenytoin had no antimanic effect even 60 minutes after administration of doses used in status epilepticus.

Fosphenytoin was more successfully used to relieve pain refractory to opiates in a 37-year-old woman with neuroma, according to Dr. Gary J. McCleane of the Rampark Pain Center in Lurgan, Northern Ireland. She was given 1,500 phenytoin equivalent units of fosphenytoin over a 24 hour period, producing pain relief that last three to fourteen weeks after each infusion, allowing her to use less opiates.

Metabolism

One mmol (millimole) of phenytoin is produced for every mmol of fosphenytoin administered; the hydrolysis of fosphenytoin also yields phosphate and formaldehyde, the latter of which is subsequently metabolized to formate, which is in turn metabolized by a folate dependent mechanism.

Side effects

Side effects are similar to phenytoin, except that fosphenytoin causes less hypotension and more paresthesia. Fosphenytoin can cause hyperphosphatemia in end-stage renal failure patients.

Read more at Wikipedia.org


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Eisai
From Drug Store News, 5/17/04 by James Frederick

Supplier News--Eisai last month closed the deal on acquiring the epilepsy treatment Zonegran (zonisamide) from Elan Pharma.

As part of the agreement, Eisai acquired exclusive North American and European manufacturing, development and marketing rights to Zonegran.

Financial terms were not disclosed. Zonegran generated $80.7 million in U.S. sales in 2003.

The acquisition represents Eisai's third agreement in the epilepsy arena. In February, Eisai in-licensed rufinamide from Novartis Pharma, and in 2002, Eisai acquired the exclusive rights to promote Pfizer's Cerebyx (fosphenytoin sodium injection).

Another anticipated addition to Eisai's neurology product line results from a May 2003 agreement with Teva for the co-development of rasagiline for Alzheimer's disease and co-promotion in the United States for Parkinson's disease, if the Food and Drug Administration approves the drug.

COPYRIGHT 2004 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2004 Gale Group

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