Noven needs new study for ADHD patch
Noven Pharmaceuticals will likely have to conduct an additional clinicaltrial of its transdermal methylphenidate patch, in development for the treatment of attention-deficit hyperactivity disorder, after disappointing results in a Phase III trial. A preliminary analysis of the trial results suggests that one aspect of the study was unsuccessful, and the company will now have to complete its review of the data and discuss with the US Food and Drug Administration how best to proceed with the program.
Noven's chief executive, Robert Strauss, noted that the company had originally planned to file a New Drug Application for the methlyphenidate patch in the second quarter of this year, but this will now have to be delayed "by six to 12 months." A launch of the product is unlikely to take place before 2003, he added.
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