Shire plc (LSE: SHP,
Nasdaq: SHPGY, TSX: SHQ) announced today that a single once-daily morning
dose of the investigational amphetamine compound SPD465, extended release
triple-bead mixed amphetamine salts, designed to reduce symptoms of
Attention-Deficit/Hyperactivity Disorder (ADHD) in adults for up to 16
hours, was bioequivalent to a dose of ADDERALL XR (mixed salts of a
single-entity amphetamine product) followed by a dose of mixed amphetamine
salts immediate release ("MAS IR") eight hours later. The results of this
phase I clinical trial in healthy adults were presented today at the 2006
U.S. Psychiatric & Mental Health Congress (USPMHC) annual meeting in New
Orleans.
"Adults with ADHD are particularly challenged by a normal day's
activities that often extend into the evening, and SPD465 offers the
possibility of full-day symptom control," said Lenard A. Adler, M.D.,
director of the Adult ADHD Program in the Departments of Psychiatry and
Neurology at New York University (NYU) School of Medicine and author of
Scattered Minds: Hope and Help for Adults with ADHD (Putnam).
On July 21, 2006, Shire submitted a New Drug Application for SPD465,
which is now under FDA review. If approved, SPD465 would be the first and
only ADHD stimulant product designed to control inattention, hyperactivity
and impulsivity in adults for up to 16 hours with one daily dose, thus
potentially eliminating the need for augmenting a long-acting stimulant
medication with a short-acting stimulant during the latter part of the day.
More than nine million American adults currently exhibit symptoms of ADHD.
About the Study
In the study, investigators randomized 20 healthy adults (average age
of 30 years), to either of two treatments, once-daily SPD465 37.5 mg or 25
mg ADDERALL XR followed by 12.5 mg of MAS IR administered eight hours
later. The researchers dispensed the assigned medication regimen to the
participants after an overnight fast and collected blood plasma samples
before dosing; hourly thereafter through the first 10 hours after dosing;
and then periodically for the next two and a half days. After a washout
period of seven days, each participant was crossed over to receive the
alternate treatment.
Bioequivalency of the two medication regimens is supported by the
pharmacokinetic data collected for both d-amphetamine and l-amphetamine.
Maximum plasma concentrations for both d-amphetamine and l-amphetamine were
similar between the SPD465 group and the ADDERALL XR plus MAS IR group
(50.3 ng/ML and 49.3 ng/mL, respectively). Both d-amphetamine and
l-amphetamine were quantifiable in plasma at one hour after dosing in both
treatment groups. Mean plasma concentration profiles of d-amphetamine and
l-amphetamine were similar throughout the day and into the evening hours
for both SPD465 and ADDERALL XR augmented with MAS IR.
No clinically meaningful differences occurred between the two study
groups regarding adverse events. The reported adverse events were generally
considered mild and resolved before study end, except one reported case of
acne. The most frequently reported adverse events in the SPD465 group of
healthy adults were hypervigilance, decreased appetite, headache, eye
irritation, back pain, increased energy and anorexia.
Shire Development Inc. supported the study.
About ADHD
ADHD is one of the most common psychiatric disorders in children and
adolescents. Although many people tend to think of ADHD as a childhood
problem, up to 80 percent of children with ADHD may exhibit symptoms into
adolescence and up to 65 percent of children with ADHD may still exhibit
symptoms into adulthood. In fact, ADHD affects approximately 9 million
adults. ADHD is a neurobiological psychiatric disorder that manifests as a
persistent pattern of inattention and/or hyperactivity-impulsivity that is
more frequent and severe than is typically observed in individuals at a
comparable level of development. A diagnosis of Attention-Deficit
Hyperactivity Disorder in adults (ADHD; DSM-IV) implies the presence of
hyperactive-impulsive and/or inattentive symptoms that cause impairment and
were present before the age of 7 years. The symptoms must cause clinically
significant impairment, e.g., in social, academic, or occupational
functioning, and be present in two or more settings, e.g., work (or school)
and at home. The symptoms must not be better accounted for by another
mental disorder.
Although there is no "cure" for ADHD, there are accepted treatments
that specifically target its symptoms. The most common standard treatments
include educational approaches, psychological or behavioral modification,
and medication.
For further information on ADHD please visit ADHDSupport,
ADD or NMHA.
About SPD465
SPD465, a single entity, mixed amphetamine salt formulation designed to
provide extended release of medication with symptom control for up to 16
hours, is being studied for the treatment of ADHD in adults. The most
common adverse events reported in the phase I study were hypervigilance,
decreased appetite, headache, eye irritation, back pain, increased energy
and anorexia.
About ADDERALL XR
Tell your doctor about any heart conditions, including structural
abnormalities, that you, your child, or a family member, may have. Inform
your doctor immediately if you or your child develop symptoms that suggest
heart problems, such as chest pain or fainting.
ADDERALL XR should not be taken by patients who have advanced disease
of the blood vessels (arteriosclerosis); symptomatic heart disease;
moderate to severe high blood pressure; overactive thyroid gland
(hyperthyroidism); known allergy or unusual reactions to drugs called
sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma;
a history of problems with alcohol or drugs; agitated states; taken a
monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell your doctor before using ADDERALL XR if you or your child are
being treated for or have symptoms of depression (sadness, worthlessness,
or hopelessness) or bipolar disorder; have abnormal thought or visions,
hear abnormal sounds, or have been diagnosed with psychosis; have had
seizures or abnormal EEGs; have or have had high blood pressure; exhibit
aggressive behavior or hostility. Tell your doctor immediately if any of
these conditions or symptoms develop while using ADDERALL XR.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events. These events
have also been reported rarely with amphetamine use.
ADDERALL XR was generally well tolerated in clinical studies. The most
common side effects in studies included: children -- decreased appetite,
difficulty falling asleep, stomachache, and emotional lability; adolescents
-- loss of appetite, difficulty falling asleep, stomachache, and weight
loss; adults -- dry mouth, loss of appetite, difficulty falling asleep,
headache, and weight loss. Aggression, new abnormal thoughts/behaviors,
mania, growth suppression, worsening of motion or verbal tics and
Tourette's syndrome have been associated with use of drugs of this type.
Tell your doctor if you or your child have blurred vision while taking
ADDERALL XR.
Shire plc
Shire's strategic goal is to become the leading specialty
pharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on central nervous system,
gastrointestinal, general products and human genetic therapies. The
structure is sufficiently flexible to allow Shire to target new therapeutic
areas to the extent opportunities arise through acquisitions. Shire
believes that a carefully selected portfolio of products with a
strategically aligned and relatively small-scale sales force will deliver
strong results.
Shire's focused strategy is to develop and market products for
specialty physicians. Shire's in-licensing, merger and acquisition efforts
are focused on products in niche markets with strong intellectual property
protection either in the US or Europe.
For further information on Shire, please visit the Company's website:
shire.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included herein that are not historical facts are
forwarding- looking statements. Such forward-looking statements involve a
number of risks and uncertainties and are subject to change at any time. In
the event such risks or uncertainties materialize, Shire's results could be
materially affected. The risks and uncertainties include, but are not
limited to: risks associated with the inherent uncertainty of
pharmaceutical research, product development, manufacturing and
commercialization; the impact of competitive products, including, but not
limited to, the impact of those on Shire's Attention Deficit and
Hyperactivity Disorder (ADHD) franchise; patents, including but not limited
to, legal challenges relating to Shire plc's ADHD franchise; government
regulation and approval, including but not limited to the expected product
approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465,
extended release triple-bead mixed amphetamine salts (ADHD), MESAVANCE
(mesalamine) with MMX technology (SPD 476) (ulcerative colitis), ELAPRASE
(idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine dimesylate)
(ADHD), including its scheduling classification by the Drug Enforcement
Administration in the United States; Shire's ability to secure new products
for commercialization and/or development; and other risks and uncertainties
detailed from time to time in Shire's and its predecessor registrant Shire
Pharmaceuticals Group plc's filings with the Securities and Exchange
Commission, particularly Shire plc's Annual Report on Form 10-K for the
year ended December 31, 2005.
Shire plc
shire
View drug information on Adderall XR; Elaprase.
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