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New Data Suggests Less Abuse-Related Effects For OROS,Methylphenidate

Two New Studies Highlight Potential Benefit of Unique OROS(R) Formulation

SAN DIEGO, May 23, 2007 /PRNewswire/ -- 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-methylphenidate stimulants, 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<0.05), and OROS(R) MPH 108 mg was consistently lower than IR MPH 90 mg. For VAS Good Effects and VAS High, both OROS(R) MPH doses had significantly lower scores than comparable IR MPH doses (P<0.05) for more time points.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable medical condition, which includes a variable attention span and/or hyperactivity or impulsivity. According to the National Institutes of Health (NIH), ADHD is one of the most common mental disorders in childhood. It affects an estimated four million children in the United States(2). Studies suggest males are more likely to be diagnosed with ADHD than females because of misconceptions and differences in symptoms.

Important Safety Information

OROS(R) methylphenidate should not be taken by patients with significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in OROS(R) methylphenidate; glaucoma; Tourette's syndrome, tics or family history of Tourette's syndrome; or current/recent use of monoamine oxidase inhibitors (MAOIs). Children under six years of age should not take OROS(R) methylphenidate. Abuse of methylphenidate may lead to dependence. OROS (R) methylphenidate is a Schedule II Controlled Substance.

Use with caution in patients with psychosis, bipolar disorder, history of seizures/EEG abnormalities, and hypertension. OROS(R) methylphenidate should not be used in patients with pre-existing severe gastrointestinal narrowing, known structural cardiac abnormalities or other serious heart problems. Stimulants may cause new psychotic or manic symptoms; discontinuation of treatment may be appropriate. Aggressive behavior or hostility should be monitored in patients beginning treatment.

Methylphenidate may produce difficulties with accommodation and blurring of vision. Hematologic monitoring is advised during prolonged therapy.

The most common adverse events reported in children aged six to 12 years receiving up to 54 mg were headache (14%), upper respiratory tract infection (8%), and abdominal pain (7%). The most common adverse events reported in adolescents receiving up to 72 mg were headache (9%), accidental injury (6%), and insomnia (5%).

About McNeil Pediatrics

McNeil Pediatrics Division of McNeil-PPC, Inc. is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. Its leading pediatric product, OROS(R) methylphenidate, is a once-a-day treatment for Attention Deficit Hyperactivity Disorder (ADHD) that uniquely combines methylphenidate with an exclusive OROS(R) delivery system. OROS(R) methylphenidate is the number one ADHD prescribed medication in the U.S. for children and adolescents. McNeil Pediatrics also markets a medication for treatment of pediatric patients with autism.

OROS(R) is a registered trade mark of ALZA Corporation.

(1) The number of prescriptions for OROS MPH(R) and other MPH treatments was similar (=28 vs 25 million), yet OROS MPH(R) accounted for 23% of DAWN reports while other MPH formulations accounted for 77%. Th e ratio of abuse reports to prescribed use for OROS(R) methylphenidate (3.2 x 10-6) was lower than that of other methylphenidate formulations (12 x 10-6); similarly, this ratio was low for atomoxtine (3.5 x 10-6). Non-methylphenidate stimulants have the highest ratio of DAWN abuse reports to prescribed use (14 x 10-6) ; Ciccone, P.E., Starr, H.L., Coleman, J.J., Mrazik, T., DuPont, R.L., Bensinger P.B., ). APA Poster Board Number NR526: OROS MPH(R): A Methylphenidate Formulation with a Low Potential for Abuse, 2007.

(2) Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, Faraone SV, Greenhill LL, Howes MJ, Secnik K, Spencer T, Ustun TB, Walters EE, Zaslavsky AM. "The Prevalence and Correlates of Adult ADHD in the United States: Results from the National Comorbidity Survey Replication." American Journal of Psychiatry. 2006. Vol 163. Pg 724-732.

CONTACT: On-Site Media Contacts, Ambre Morley of McNeil Pediatrics,Office, +1-609-730-3429, Cell, +1-908-507-0160, Christina Witz of DeVriesPublic Relations, Office, +1-212-891-0455, Cell +1-646-509-9379, for McNeilPediatrics

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