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 placebo, respectively.
"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 predetermined formula.
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.
SOURCE ALZA Corporation