Further Study on ADDerall
SOURCE: Shire Pharmaceuticals Group plc
Pivotal Study of New, Once Daily ADHD Medication to be
Presented At American Psychiatric Association Meeting
-- Study Is One of The Largest Ever ADHD Medication Trials --
ANDOVER, United Kingdom, March 5 /PRNewswire/ -- Shire
Pharmaceuticals Group plc (Nasdaq: SHPGY; London:
SHP.L) today announced that new pivotal data on the
once daily medication it is developing for the
treatment of attention deficit/hyperactivity disorder
(ADHD) have been accepted as a platform presentation at
the annual meeting of the American Psychiatric
Association (APA). The oral presentation of safety and
efficacy results will take place on Wednesday, 9 May,
at 11:00 am at the APA's 2001 annual meeting in New
Orleans.
The once daily medication, currently known by its
project designation, SLI 381 (proposed Trade Mark
ADDERALL XR), is a novel formulation of ADDERALL®
(mixed salts of a single-entity amphetamine product)
that incorporates Shire's Microtrol(TM) advanced drug
delivery system. Shire filed a new drug application for
SLI 381 with the US Food and Drug Administration on 3
October, 2000.
"We are honored that the APA has chosen the study
results for a platform presentation," said Wilson
Totten, Shire's Group R&D Director. "We believe
strongly in this product, and our hope is that if
approved by the FDA, it will have a profound effect on
the way ADHD is treated."
The Phase III, randomized, double blind, placebo
controlled, parallel group study is one of the largest
ever medication trials in ADHD research. The study
results will be presented by Joseph Biederman, M.D.,
Professor of Psychiatry at Harvard Medical School, who
participated in the clinical trial and is a world
renowned researcher in the field of ADHD and pediatric
psychopharmacology.
"Having these study results presented at APA will
bring attention to the need for once daily dosing of
ADHD medication, the future of ADHD treatment," Dr
Beiderman said.
About ADHD
ADHD is considered the most commonly diagnosed
psychiatric disorder among children.(A) Children with
ADHD often are inattentive, impulsive, and hyperactive -
- difficulties serious enough to interfere with their
ability to function normally in academic or social
settings.
Although there is no ``cure'' for ADHD, physicians,
parents, teachers, nurses, and advocates are finding
ways to help people with the condition learn to adapt
to their academic, social, and work settings. ADHD
usually can be successfully managed with a combination
of treatments, including educational approaches,
psychological and behavioral therapies, and medication.
A recent government-sponsored clinical trial found that
therapies that include carefully monitored medication
are more effective than those that do not, such as
behavioral therapy alone.(B) Medication should be
considered part of an overall multimodal treatment plan
for ADHD.
Shire Pharmaceuticals Group plc
Shire is an international specialty pharmaceutical
company with a strategic focus on four therapeutic
areas: central nervous system disorders, metabolic
diseases, oncology and gastroenterology. The Group has
a sales and marketing infrastructure with a broad
portfolio of products, with its own direct marketing
capability in the US, Canada, UK, Republic of Ireland,
France, Germany, Italy and Spain and with plans to add
Japan by 2004. Shire also covers other significant
pharmaceutical markets indirectly through distributors
and sales coverage continues to grow.
Shire's global search and development expertise has to
date successfully provided eight marketed products, of
which Reminyl* for the treatment of Alzheimer's disease
has recently been launched in the UK, its first market
in Europe. The National Institute of Clinical
Excellence (NICE) recommended on 19 January 2001 that
treatment for Alzheimer's disease be made available
through the National Health Service (NHS) in the UK.
Additionally, on 28 February 2001 Reminyl® received
Food and Drug Administration (FDA) approval to be
marketed in the US. The current pipeline of 17 projects
includes Reminyl* in registration phase in various
other markets, SLI 381, Shire's once a day formulation
of Adderall* for ADHD which was submitted to the FDA on
3 October 2000 and 8 others that are post Phase II.
Shire is actively seeking to acquire further marketed
products and development projects to enhance the
potential for future growth. Shire's M&A activity has
resulted in five completed mergers and acquisitions
during the last six years.
On 11 December 2000, Shire entered into an agreement to
merge with BioChem Pharma Inc. to form a leading global
specialty pharmaceutical company.
More details on this proposed merger and other aspects of the company are
available on the Shire website at www.shire.com.
* Trade Mark
References
(A) Cantwell DP. Attention Deficit Disorder: A Review of the Past 10 Years. J Am Acad Child Adolesc Psychiatry. 1996;35:978-987.
(B) The MTA Cooperative Group. A 14-Month Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder.
Arch Gen Psychiatry. 1999;56:1073-1086.
SOURCE: Shire Pharmaceuticals Group plc