Date: October 24, 2002
NOVEN ANNOUNCES POSITIVE PHASE III STUDY RESULTS
FOR ONCE-DAILY ADHD TRANSDERMAL PATCH
Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced positive Phase III clinical study results for its once-daily transdermal methylphenidate system. The double-blind, placebo-controlled, multi-center Phase III study was conducted to assess the efficacy and safety of Noven's developmental methylphenidate patch for Attention-Deficit Hyperactivity Disorder (ADHD), which Noven intends to market under the trade name MethyPatch(r).
The four-week study involved 212 patients (ages 6 to 12 years) meeting the DSM-IV criteria for ADHD. Patients were randomized to apply MethyPatch or a placebo transdermal patch once-daily to the hip area. Six MethyPatch dosage strengths were available for titration. The primary efficacy measure was improvement in patient behavior and attention as rated by community school teachers using the Inattention/Overactivity with Aggression (IOWA) Conners behavioral rating scale. Secondary efficacy measures included improvement in patient behavior as rated by parents and clinicians.
The study results indicated that MethyPatch was significantly superior to placebo on all primary and secondary efficacy measures. Compared with placebo, MethyPatch, worn for approximately 12 hours per day, resulted in significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention. The p-value for each measure was less than 0.0001, reflecting high statistical significance.
At week four of the study, patient mean Inattention/Overactivity scores (scores range from 0 to 15) as rated by teachers showed highly significant improvement (p-value less than 0.0001) from baseline as compared to placebo (MethyPatch group improved 6.1 points; placebo group improved 2.0 points).
No serious adverse events occurred in patients receiving MethyPatch. The most common adverse events were reduced appetite, insomnia, abdominal pain and headache. Four patients (3.8%) in the MethyPatch group and three patients (2.9%) in the placebo group withdrew from treatment due to adverse events.
As part of the study, parents were asked to complete a MethyPatch satisfaction survey. 98.5% of responding parents agreed that being able to remove the patch and discontinue treatment at any time provided them with a sense of control, and 64.2% indicated that they had no difficulty in properly applying MethyPatch.
MethyPatch combines methylphenidate - an established ADHD therapy - with Noven's patented DOT Matrix(tm) patch technology. DOT Matrix permits Noven to deliver predictable therapeutic doses of a range of prescription therapies through discreet, comfortable and adherent patches that are well suited to active lifestyles. In addition to DOT Matrix patents, Noven holds patents on the transdermal delivery of methylphenidate via a patch system.
The Phase III study was part of a MethyPatch clinical trial program sponsored by Noven that spanned several years and included over 700 subjects in centers across the U.S. In June 2002, Noven submitted a New Drug Application to the U.S. Food & Drug Administration seeking approval to market MethyPatch for the treatment of ADHD, and the application is currently under review.
ADHD is characterized by developmentally inappropriate impulsivity, inattention and hyperactivity. ADHD affects 3% to 5% of school-aged children, and an estimated 1.5 million children are currently on medication to treat this disorder. All presently approved ADHD medications are delivered orally.
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Together with Novartis Pharmaceuticals Corporation, Noven owns a highly profitable women's health products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen and combination estrogen/progestin transdermal delivery systems using DOT Matrix technology. With a range of additional products in development, including MethyPatch, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal drug delivery systems. For additional information, visit Noven's website at www.noven.com. MethyPatch(r) and DOT Matrix(tm) are trademarks of Noven Pharmaceuticals, Inc.
This release contains forward-looking statements related to the business of Noven that can be identified by the use of forward-looking terminology such as "expects" and similar words and phrases. Such statements are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission and in this press release, including the risk that MethyPatch may not be approved or, if approved, that it may not "Parents Love MethyPatch for the Treatment of ADHD!!! - Positive Phase III Clinical Trial Results for ADHD Treatment for Children"be the first transdermal ADHD therapy on the market or that it may not be successfully commercialized due to competitive market conditions or other factors, including physician/patient preferences for other ADHD therapies. FDA will examine data from the most recent Phase III study together with data from other MethyPatch studies sponsored by Noven, and there can be no assurance that FDA will deem all of such data sufficient to approve the product for marketing or to authorize the product's use in the manner described by Noven. The timing of any FDA approval is outside the control of Noven. There are several other once-daily ADHD medications on the market, and other products that may have improved safety and efficacy profiles are also in development.