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MethyPatch Noven.

Natasha Sane¹, James J McGough

¹University of California at Los Angeles, 90095, USA.

Current Opinion in Investigational Drugs (London, England : 2000)

|September 5, 2002

Summary

Noven Pharmaceuticals is developing a novel transdermal methylphenidate patch for attention deficit hyperactivity disorder (ADHD). Phase III trials were completed, and regulatory filings are underway for a potential 2003 product launch.

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Area of Science:

Pharmacology
Drug Delivery Systems
Neuroscience

Background:

Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder.
Current ADHD treatments include oral medications, which can have limitations.
Transdermal drug delivery offers potential advantages in medication adherence and pharmacokinetic profiles.

Purpose of the Study:

To evaluate the efficacy and safety of a novel transdermal methylphenidate patch for ADHD treatment.
To support regulatory filings for the new ADHD therapeutic.

Main Methods:

Development of a transdermal patch formulation of methylphenidate.
Conducting pivotal, double-blind, placebo-controlled, multicenter Phase III clinical trials.
Analysis of trial data to support New Drug Application (NDA) submission.

Main Results:

Phase III trials for the transdermal methylphenidate patch have been successfully completed.
Preliminary analyses indicated the need for a supplemental study to support regulatory filing.
The company filed an NDA with the FDA based on pivotal Phase III trial results.

Conclusions:

Noven Pharmaceuticals is advancing a transdermal methylphenidate patch for ADHD.
Regulatory submission and potential market launch are anticipated following trial completion and NDA filing.

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