FDAnews Drug Daily Bulletin

ADHD PATCH HEADED FOR ADVISORY COMMITTEE REVIEW

Nov. 7, 2005
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Noven Pharmaceuticals' investigational attention-deficit/hyperactivity disorder (ADHD) drug MethyPatch will be reviewed in December by the FDA's Psychopharmacologic Drugs Advisory Committee.

The advisory panel will review Noven's new drug application (NDA) for MethyPatch (methylphenidate transdermal system) Dec. 2. If approved, the drug would be the first methylphenidate patch available to treat ADHD. Financial analysts believe the potential market for the drug is large because the transdermal delivery system offers significant advantages over oral ADHD drugs, including minimizing the potential for abuse, and allowing for easier administration of the drug
.
The application process has been a slow one for Noven up to this point. The firm originally wanted to file its NDA for MethyPatch in mid-2001, but the filing was delayed after the results of a Phase III trial were inconclusive. In April 2003, Noven received a "not approvable" letter from the FDA requesting additional clinical data on the drug.

For more information about the meeting, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005-4195-nm00001.pdf.


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The advisory panel will review Noven's new drug application (NDA) for MethyPatch (methylphenidate transdermal system) Dec. 2. If approved, the drug would be the first methylphenidate patch available to treat ADHD. Financial analysts believe the potential market for the drug is large because the transdermal delivery system offers significant advantages over oral ADHD drugs, including minimizing the potential for abuse, and allowing for easier administration of the drug
.
The application process has been a slow one for Noven up to this point. The firm originally wanted to file its NDA for MethyPatch in mid-2001, but the filing was delayed after the results of a Phase III trial were inconclusive. In April 2003, Noven received a "not approvable" letter from the FDA requesting additional clinical data on the drug.

For more information about the meeting, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005-4195-nm00001.pdf.