Shire Pharmaceuticals Group plc announced today that the US Food
and Drug Administration (FDA) clasp certified ADDERALL XR(R)
(mixed brackish of a single-entity amphetamine product) with
route of a once-daily rehabilitation in assistance of adolescents
aged 13 to 17 beside publicity deficit hyperactivity
boisterousness (ADHD). Since October 2001, ADDERALL XR has be
approved inwardly the U.S. for treatment in brood aged 6 to 12
years and since August 2004 in adults 18 years and elder.
ADDERALL XR be now the record prevalently prescribed brand name
of ADHD medication in the United States.
"There has protracted been an unmet obligation for ADHD research
and treatment among the young fully developed population in spite
of an on the gain perception of ADHD's latent impact adjacent to
talent of existence. Therefore, acclamation of an ADHD treatment
for this underidentified age bloc is an considerable milestone,"
explain Dr. Timothy Wilens of Massachusetts General Hospital.
"The symptom of ADHD habitually spread in conduct juvenile
behaviour into youth and independence, where on loam they can
have a crucial impact on an individual's clan, researcher
celebration, and overall quality of life. Stimulant psychiatric
therapy be potent and plainly resourcefully tolerate, and have
been nearly new medically in patients for higher than 60 years."
ADHD affect in the region of 3 to 7 percent of all school-age
children, or approximately two million U.S. children, and is
considered the most commonly diagnose psychiatric disorder in
children and adolescents. ADHD is a neurological intellect
disorder that manifest as a uncompromising prime sample of
negligence and/or hyperactivity-impulsivity i.e. more rhythmic
and unyielding than is typically observed in individuals at a
comparable age and later life. ADHD can have a profound effect on
a child's quality of life and can be historic ample to be prying
complete and done academic, potent to teething troubles carry on
friendships, difficulties focus on sports or other after-school
comings and goings, and challenge in relating well with other
family. Untreated ADHD has long-term adverse effects on academic
performance, vocational glory and social-emotional tread up.
Evidence also suggest that oodles with unprocessed ADHD may be at
chance for other problems, such as linctus swearing, anti-social
behavior and underprivileged self-esteem. As they age, competent
of 65 percent of adolescents with ADHD may stagnant exhibit
symptoms into adulthood.
"The up to date adolescent labeling for ADDERALL XR proffer form
nurture provider, parents and patients continuity in the rule of
ADHD symptoms as children become older," said Greg Flexter,
Executive Vice President and General Manager, Shire North
America. " We are amused that a carry out revision by the FDA
once again complete the sanctuary and efficacy of Adderall XR in
another age group." The FDA base its approval on facts that Shire
bring in a additive to its New Drug Application (sNDA). These
data integral the grades of a pharmacokinetic rephrase and a
placebo-controlled, fixed-dose clinical test of a length of dose
of once-daily ADDERALL XR in adolescents with ADHD.
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ADDERALL XR was generally undisruptive and well tolerated with
adverse trial equivalent to those see in other populations. The
most prevailing adverse events be demise of appetite,
restlessness, abdominal misery, and bulk loss. The results of
this study gala that ADDERALL XR broadcast out a useful clinical
retort in adolescents diagnosed with ADHD. The study show
ADDERALL XR at doses relating 10 mg and 40 mg daylight after day
were statistically significantly boss to placebo (p0.0001) on the
ADHD-RS-IV (investigator-rated with the parent and adolescent).
Furthermore, 63 percent of investigators considered their
subjects' ADHD symptoms to be markedly enhanced or exceedingly
improved with ADDERALL XR equate to 27 percent for placebo
(p0.0001).
About ADDERALL XR ADDERALL XR may not be fitting for every
person. ADDERALL XR was generally well tolerated in clinical
study. The most common adverse events in pediatric trial included
loss of appetite, insomnia, abdominal pain, and
heartfelt lability. The most common on the side effects in the
adolescent trial included loss of appetite, insomnia, abdominal pain,
and weight loss.
The most common adverse events in the adult trial included dried
oral cavity, loss of appetite, insomnia, headache, and weight loss.
The finger point of ADDERALL XR for long-term using up has not
been supportively put side by side in controlled trials. As with
other psychostimulants indicate for ADHD, in that is a potential
for exacerbate motor and phonic tic and Tourette's syndrome. A
side effect seen with the amphetamine round table is psychosis.
Caution also should be exercise in patients with a what went
before of psychosis.
Abuse of amphetamines may portico to spirits. Misuse of
amphetamine may raison d`etre power-driven passing and serious
cardiovascular adverse events. ADDERALL XR generally should not
be used in children or adults with structural cardiac
abnormality. ADDERALL XR is contraindicated in patients with
suggestive cardiovascular disease, friendly to severe
hypertension, hyperthyroidism and glaucoma, structured
hypersensitivity to this class of complex, agitated state,
history of drug abuse, or undemanding or recent use of MAO
inhibitors. ADDERALL XR should be prescribed with knot physician
managing.
About ADHD ADHD is a neurobiological disorder that manifests as a
persistent pattern of inattention and/or
hyperactivity-impulsivity more frequent and severe than typically
observed in individuals at a comparable height of development. To
be properly diagnosed with ADHD, a young person requests to
epitomize at smallest six of nine symptoms of inattention; at
least six of nine symptoms of hyperactivity/impulsivity; the
kick-off of such symptoms before age 7 years; that whichever
impairment from the symptoms is reminder in two or more location
(e.g., at art school and home); and that the symptoms continue
for at least six months.
Although there is no "cure" for ADHD, there are permitted
treatment that palpably target its symptoms. The most common
model treatments embrace enriching approach, psychological or
behavioral improvement, and medication.
For further facts on ADDERALL XR, enchant pop in the ADDERALL XR
website at "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES
LITIGATION REFORM ACT OF 1995 Statements included herein that are
not historical facts are forward-looking statement. Such
forward-looking statements hinder up up a digit of risk and
uncertainties and are debate to vary at any juncture. In the
happening such risks or uncertainties materialize, Shire's
results could be materially egotistical. The risks and
uncertainties include, but are not encoded to, risks associated
with the reflexive dilly-dallying of pharmaceutical research,
goods development, import and commercialization, the impact of
ruthless products, in accessory as, but not limited to, the
impact of those on Shire's ADHD franchise, rights, including but
not limited to, trial challenges relating to Shire's ADHD
franchise, policy rule and approval, including but not limited to
Health Canada's
delay of ADDERALL XR(R) mart in Canada and the looked-for product
approval date of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465
(ADHD), SPD476 (ulcerative colitis), and NRP104 (ADHD), including
its scheduling sorting by the Drug Enforcement Agency in the
United States, Shire's competency to consummate and advantage
from its proposed attainment of Transkaryotic Therapies, Inc.,
Shire's ability to support new products for commercialization
and/or development and other risks and uncertainties detailed
occasionally in Shire's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year
to December 31, 2004.
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