New ADD/ADHD Drug Trials
Clinical Results of Once-Daily Treatment for ADD/ADHD Announced by ALZA And
Initial Efficacy Data of Concerta(TM), OROS(R) Methylphenidate,
Highlighted at AACAP Meeting
MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ -- ALZA Corporation (NYSE: AZA)
and Crescendo Pharmaceuticals Corporation (Nasdaq: CNDO) today announced the
first presentation of pivotal clinical results of OROS(R) methylphenidate,
which ALZA has named Concerta(TM) (methylphenidate HCl) extended-release
tablets. The results, which were included in a New Drug Application
submitted to the U.S. Food and Drug Administration earlier this year, provide
initial data on the product's safety and efficacy in children with Attention
Deficit Disorder and Attention Deficit Hyperactivity Disorder (ADD/ADHD).
The studies were presented at the 46th annual meeting of the American Academy
of Child and Adolescent Psychiatry (AACAP) in Chicago.
Concerta(TM), which is under development by ALZA for Crescendo as a
once-daily treatment for ADD/ADHD, utilizes a novel application of ALZA's
OROS(R) osmotic technology designed to deliver a unique pattern of
methylphenidate throughout the day.
In the double-blind crossover study presented at AACAP, 68 children between
the ages of 6 and 12 with a clinical diagnosis of ADD/ADHD were given
Concerta(TM) once daily, conventional (immediate-release) methylphenidate
three times daily or placebo. The children were evaluated by various
assessors both in the regular classroom setting and on three consecutive
Saturdays in a laboratory school, a specialized school used to monitor
children with ADD/ADHD for treatment evaluation purposes.
An assessment of children's behavior was recorded using the
Inattention/Overactivity with Aggression (IOWA) Conners measurement scale,
which ranked behavior on a scale of 0 to 15, with higher ratings reflecting
higher degrees of inattention and overactivity. Based on this measurement, a
significant reduction in inattention and overactivity was shown for both
Concerta(TM) and conventional methylphenidate when compared with placebo
(p<0.001). Analysis of teachers' ratings of children in the laboratory
setting showed mean ratings of 2.59 (with standard deviation of 3.91), 2.75
(SD 3.73) and 5.01 (SD 4.48) for children taking Concerta(TM), conventional
methylphenidate and placebo, respectively.
Similar results also were demonstrated in the community school. In this
setting, an analysis of teachers' ratings of children showed mean inattention
and overactivity ratings of 4.69 (SD 3.31), 5.00 (SD 3.69) and 10.41 (SD
4.21) for children taking Concerta(TM), conventional methylphenidate and
"In this study, the effects achieved with Concerta(TM) lasted throughout a
child's 12-hour day, including the homework period and during after-school
activities. This is important because children with ADHD often show
impairment during these times, and medication may help improve a child's
functioning," said William E. Pelham, Ph.D., professor of Psychology and
director of Clinical Training at the State University of New York at Buffalo,
who presented the data at the meeting. "We believe a once-daily dosing
regimen may afford an opportunity to increase compliance, as neither the
child nor school staff needs to remember to administer additional doses
during the day."
Similar results were seen in a second study of similar design involving 61
children with a clinical diagnosis of ADD/ADHD. In this study, an analysis
of teachers' ratings of children in the laboratory setting showed mean
ratings of 5.25 (SD 3.90), 4.82 (SD 3.39) and 8.77 (SD 4.11) for children
taking Concerta(TM), conventional methylphenidate and placebo, respectively.
In the community school setting, teachers' ratings showed mean inattention
and overactivity ratings of 6.66 (SD 3.58), 7.11 (SD 4.18) and 11.60 (SD
3.86) and parents' assessments showed ratings of 5.32 (SD 2.99), 5.97 (SD
3.22) and 9.90 (SD 3.65) for children taking Concerta(TM), conventional
methylphenidate and placebo, respectively.
"Various measures of assessment were used to observe the effects of
Concerta(TM) including the SKAMP rating scale, which demonstrated an
improvement in behavior 12 hours into a child's day," said James M. Swanson,
Ph.D., director of the Child Development Center and professor of Pediatrics
and Cognitive Sciences, University of California, Irvine, who presented these
findings in an oral presentation at AACAP. "We are extremely encouraged by
the potential role of Concerta(TM) in the treatment of ADD/ADHD."
Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder is
characterized by symptoms of inappropriate inattention, hyperactivity and
impulsiveness. ADD/ADHD represents the most common psychiatric disorder in
children; according to the American Psychiatric Association, the disorder
affects approximately 3 percent to 5 percent of the school-age population.
In a limited number of patients, the symptoms of ADD/ADHD persist into
adulthood. Males are three to five times more likely than females to be
diagnosed with ADD/ADHD.
In clinical trials, the most common treatment-related side effect reported by
patients taking Concerta(TM) was headache (11 percent). Other side effects
included stomach pain (8 percent), vomiting (3 percent), cough (3 percent),
sleeplessness (2 percent) and dizziness (2 percent). Chronic abusive use of
methylphenidate can lead to marked tolerance and psychological dependence
with varying degrees of abnormal behavior.
Crescendo Pharmaceuticals Corporation was formed by ALZA for the purpose of
selecting and developing human pharmaceutical products for commercialization,
most likely through licensing to ALZA. Under agreements between ALZA and
Crescendo, ALZA will undertake the development of products for Crescendo.
ALZA has the option to license each Crescendo product, and an option to
purchase all the Crescendo Class A common stock at a price set according to a
ALZA Corporation, headquartered in Mountain View, California, is a
research-based pharmaceutical company with leading drug delivery
technologies. The company applies its delivery technologies to develop
pharmaceutical products with enhanced therapeutic value for its own portfolio
and for many of the world's leading pharmaceutical companies. ALZA's sales
and marketing efforts are currently focused in urology and oncology.
NOTE: Copies of ALZA's news releases, quarterly reports and corporate fact
sheets are available through ALZA's automated fax line at 800-859-5910. ALZA
news releases also can be found on the World Wide Web at http://www.alza.com.
SOURCE ALZA Corporation