Daytrana

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Daytrana® is a medicinal patch developed and marketed by Noven Pharmaceuticals, Inc. that was approved in April 2006. 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 17—with attention deficit hyperactivity disorder (ADHD). 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 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]

Transdermal versus oral administration[edit]

Unlike with transdermal administration, orally administered methylphenidate is subject to first-pass metabolism, by which the levo-isomer is extensively metabolized. By circumvention of this first-pass metabolism the relative concentrations of l-threo-methylphenidate are much higher with transdermal administration (50-60% of those of dexmethylphenidate instead of about 14-27%). [2] [3] Because the d-enantiomer is pharmacologically the most active one by far, this is of limited importance.

Footnotes[edit]

  1. ^ http://www.fda.gov/ohrms/dockets/AC/05/briefing/2005-4195B1_01_04-Noven-Appendix-3.pdf
  2. ^ 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). doi:10.2165/00023210-200620090-00002. PMID 16953648. 
  3. ^ Anderson Vanessa R., Lesley J. Scott (2006). "Methylphenidate Transdermal System In Attention-Deficit Hyperactivity Disorder in Children". Drugs 66 (8): 1117–1126. doi:10.2165/00003495-200666080-00007. PMID 16789796. 

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