Daytrana
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Daytrana (formerly known as MethylPatch) is a medicinal patch marketed by Shire Pharmaceuticals and developed under contract by Noven Pharmaceuticals that was approved in June 2007. In the literature, Daytrana is most commonly referred to as Methylphenidate Transdermal System (MTS).
Daytrana is approved by the U.S. Food and Drug Administration (FDA) as a once daily treatment of pediatric patients—ages 6 to 12—with Attention Deficit Hyperactivity Disorder. However, off-label prescriptions in older patients are not uncommon. It is mainly prescribed as a second-line treatment for ADHD when traditional oral forms are not well-tolerated or if patients have difficulty with compliance.
Noven's original FDA submission of MethylPatch indicated that it should be used for 12 hours; when the FDA rejected the submission they requested evidence that a shorter time period was safe and effective; Noven provided such evidence and Daytrana was approved for the aforementioned indication over a 9 hour period. [1]
Oral-based methylphenidate pharmaceuticals are subject to first-pass hepatic metabolism and the levo-isomer is extensively metabolized, consequently contributing nothing to the dextro-isomer's clinical value; whereas MTS is transdermal, thus avoids most first-pass hepatic metabolism and the levo-isomer accounts for a thirteenth of MTS's total clinical value.[2][3]
Daytrana continues this progression toward greater abuse resistance by providing a non-oral, non-granulated package that can be removed at will.
A patch is preferable in cases where substance abuse is an issue, as a patch cannot easily be tampered with.
[edit] Footnotes
- ^ http://www.fda.gov/ohrms/dockets/AC/05/briefing/2005-4195B1_01_04-Noven-Appendix-3.pdf
- ^ Heal DJ, Pierce DM (2006). "Methylphenidate and its isomers: their role in the treatment of attention-deficit hyperactivity disorder using a transdermal delivery system". CNS Drugs 20 (9): 713–738 (Page:730). PMID 16953648.
- ^ Anderson Vanessa R., Lesley J. Scott (2006). "Methylphenidate Transdermal System In Attention-Deficit Hyperactivity Disorder in Children". Drugs 66 (8): 1117–1126.
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