New Data Suggests Less Abuse-Related Effects For OROS(R) Methylphenidate

Stimulant drug abuse remains an
ongoing concern for parents and physicians who prescribe medications to
treat Attention Deficit Hyperactivity Disorder (ADHD). Data presented on
Tuesday at the 160th Annual Meeting of the American Psychiatric Association
highlighted findings that long-acting OROS(R) methylphenidate had fewer
reports of abuse and lower abuse-related effects compared with other long-
and short-term stimulant medications for ADHD.



The unique, long-acting OROS(R) methylphenidate formulation initially
releases the drug, followed by a more gradual release of the remaining dose
in an ascending pattern, compared with an immediate-release, or
short-acting, methylphenidate formulation. The data presented Tuesday from
two sources - a national review of emergency department visits and a
pharmacokinetic/pharmacodynamic study - highlights a possible benefit
related to reduced abuse potential that may be associated with the OROS(R)
methylphenidate formulation.



"Although methylphenidate is proven to be an effective treatment for
ADHD, some physicians may have concerns about the drug due to its abuse
potential," said John J. Coleman, Ph.D., president of Prescription Drug
Research Center. "Most patients take prescription medications responsibly,
however, recent reviews still show that illicit stimulant use among
adolescents in the United States remains a concern for physicians, parents
and the general public."



About The Data



Drug Abuse Warning Network (DAWN) Review of Drug-Related Emergency
Department Visits Among ADHD Treatments (APA Poster Board NR526)



DAWN data, a national health surveillance system that monitors
drug-related emergency department visits, was used to examine emergency
department visits resulting from the abuse of ADHD medication during a
three-year period. The medications evaluated included OROS(R)
methylphenidate, other methylphenidate formulations, non-methylphenidat
estimulants, and non-stimulant atomoxetine.



A review of this data found that OROS(R) methylphenidate had a lower
frequency of emergency department reports of abuse compared to other
methylphenidate formulations. Furthermore, DAWN found that of all ADHD
treatments, non-methylphenidate stimulants (e.g., amphetamines, mixed
amphetamine salts) had the most emergency department reports of abuse.



The DAWN data highlights the "abuse-to-prescribed-use" ratio of ADHD
drugs, in which OROS(R) methylphenidate was lower than that of other
methylphenidate formulations, and similar to that of atomoxetine. The study
found the highest abuse-to-prescribed-use ratio among non-methylphenidate
stimulant formulations(1). (The abuse-to-prescribe-ratio was determined by
dividing reported emergency department visits for abuse by the number of
prescriptions dispensed for each type of ADHD drug during the three-year
period.)
















Overall findings showed that of the 1,102 reports of abuse gathered,
long-acting OROS(R) methylphenidate had the least number of reports (89),
compared with other long- and short-acting methylphenidate formulations
(301), and non-methylphenidate stimulants (651). Only the non-stimulant
drug, atomoxetine, had a lower number of overall reports at 61.



Pharmacokinetics and Pharmacodynamics of Abuse Potential (APA Poster
Board NR525)



The other data presented Tuesday found that long-acting OROS(R)
methylphenidate produced lower abuse-related subjective effects compared to
immediate-release methylphenidate at comparable total doses. In this
double-blind, placebo-controlled, randomized, crossover study, 49
occasional stimulant-abusing adults were given 50 mg and 90 mg doses of
immediate-release methylphenidate and 54 mg and 108 mg doses of OROS(R)
methylphenidate. The long-acting OROS(R) methylphenidate formulation
releases drug in a more gradual pattern compared with an immediate-release
methylphenidate formulation.



Researchers were able to determine the direct effect on the subjects'
perception and enjoyment of the medications tested, drug-liking features
that are thought to be associated with a medication's potential for abuse.
At comparable doses, abuse-related effects were lower when subjects
received the OROS(R) methylphenidate formulation.



Pharmacodynamics of potential abuse were assessed with Visual Analog
Scales (VASs). The magnitude of scores on the VAS scales was ranked (lowest
to highest) as placebo < OROS(R) methylphenidate (MPH) 54 mg, < OROS(R) MPH
108 mg, < immediate-release (IR) MPH 50 mg and < IR MPH 90 mg. For the VAS
Drug Liking scores, OROS(R) MPH 54 mg was significantly lower than IR MPH
50 mg (P