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NOVEN
ANNOUNCES POSITIVE PHASE III STUDY RESULTS |
BackMiami, FL, October
24, 2002 -- 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®.
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™ 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® and DOT Matrix™ 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 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.
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Stephanie Lamenta
Golin/Harris International
(305) 573-9955 ext. 222
(305) 495-8003 (cell)
Copyright © 2002 Noven Pharmaceuticals, Inc. All rights reserved.