Daytrana™ transdermal patch
approved by FDA for treatment of ADHD
Guide to using Daytrana
Philadelphia, PA, US and Basingstoke, UK
- April 6, 2006 -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ)
announced today that the U.S. Food and Drug Administration (FDA)
approved Daytrana (methylphenidate transdermal system), the first and
only non-oral medication for the treatment of attention deficit
hyperactivity disorder (ADHD). Daytrana, a once daily transdermal patch
formulation of methylphenidate, will be available in 10 mg, 15 mg, 20 mg
and 30 mg dosage strengths.
"The approval of Daytrana is
important news for ADHD patients, their families and healthcare
providers. In addition to being the only patch treatment for ADHD, it
offers a convenient option to deliver medicine for those diagnosed with
ADHD," said Shire Chief Executive Officer Matthew Emmens. "The
addition of Daytrana to Shire's portfolio reaffirms our position as the
market leader in ADHD."
Shire and Noven Pharmaceuticals, Inc.
submitted an amended New Drug Application (NDA) for Daytrana to the FDA
in June of last year. Daytrana is licensed globally to Shire by Noven
and is now available in pharmacies in the U.S.
The efficacy of Daytrana was established
in two controlled clinical trials in children aged 6 to 12 years old
with ADHD. Daytrana combines methylphenidate, a medication with a
50-year history of use, with Noven's patented DOT Matrix™ transdermal
technology. This transdermal delivery system delivers medication
directly through the skin into the bloodstream, and is designed to
provide consistent, smooth drug release throughout the day. The patch is
designed to stay on during the normal daily activities of a child,
including swimming, exercising, and bathing. Because Daytrana is a
patch, physicians can manage the duration of its effect and potential
side effects by having the patient wear the patch for a shorter time
period than the recommended 9 hour wear time on a given day. In clinical
trials, wearing a Daytrana patch for 9 hours provided a duration of
effect of 12 hours.
"The FDA's approval of Daytrana
offers an important new option in the treatment of ADHD in
children," said Robert Findling, MD, lead investigator and
Professor of Psychiatry; Director, Division of Adolescent and Child
Psychiatry, Case Western University. "Daytrana has been shown to be
effective and generally well tolerated in clinical studies, and offers
ADHD treatment in the convenient form of a patch."
As part of the agreement between Shire
and Noven for Daytrana, Shire completed an upfront payment to Noven of
$25 million in 2003, and may make separate milestone payments up to $125
million; $50 million will be paid dictated by this FDA approval and $75
million conditioned upon the achievement of certain sales targets.
Daytrana Significantly Controls ADHD
Symptoms
Data from phase II and phase III clinical
trials demonstrated statistically significant improvements in the
primary and secondary endpoints analyzed for children treated with
Daytrana compared to children treated with placebo.
The phase II analog classroom study
included 79 children with ADHD. The patch was worn for nine hours, and
efficacy was assessed throughout the day for 12 hours. Daytrana
demonstrated statistically significant improvement over placebo on the
measures tested. Behavior, which was measured using the Swanson, Kotkin,
Agler, M-Flynn, and Pelham-Deportment (SKAMP-D) scale, was improved with
Daytrana overall (mean score 3.2 for Daytrana versus 8.0 for placebo)
and at all time points assessed up to and including 12 hours
post-application (P < .01). The mean number of math problems
attempted by children taking Daytrana on the Permanent Product Measure
of Performance (PERMP) scale was significantly more than those taking
placebo (P <.0001) and this same group also completed more
math problems correctly than did those taking placebo (P
<.0001).
In the phase III naturalistic trial with
270 participants, investigators found that Daytrana worn for nine hours
reduced the children's overall symptoms of ADHD, compared to a placebo (P
< .0001), as measured by scores on the ADHD Rating Scale-IV
(ADHD-RS-IV). By the study's end, mean ADHD-RS-IV scores declined 56%
(24.2 points) from baseline for children treated with Daytrana versus a
decline of 25 % (10.3) for those treated with placebo (P <
.0001). ADHD-RS assesses 18 individual symptoms of ADHD as defined by
the Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision®, a publication of the American
Psychiatric Association.
In both studies, Daytrana was generally
well tolerated during both the dose optimization and double-blind
phases. Adverse events typically were mild to moderate, resolved with
continued therapy and were consistent with known effects of
methylphenidate. Common adverse events seen in clinical trials included:
decreased appetite, insomnia, nausea, vomiting, weight loss, tic, and
affect lability (mood swings).
More details: http://www.daytrana.com
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