Daytrana
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Daytrana (formerly known as MethyPatch) is a medicinal patch marketed by Shire Pharmaceuticals and developed under contract by Noven Pharmaceuticals. In the literature Daytrana is most commonly referred to as Methylphenidate Transdermal System (MTS).
Daytrana is FDA approved as a once daily treatment of pediatric patients—ages 6 to 12—with Attention Deficit Hyperactivity Disorder.
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 Daytana was approved for the aforementioned indicated use 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.
[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.