ADHD PATCH HEADED FOR ADVISORY COMMITTEE REVIEW
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.