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McNeil Pediatrics New Study Supports Low Abuse Potential Of Leading ADHD Medication, CONCERTA(R) (methylphenidate HCl)


10/27/2006 5:44:18 PM

FORT WASHINGTON, Pa., Oct. 27 /PRNewswire/ -- Results of a new study found that an extended-release form of methylphenidate -- sold as CONCERTA(R) (methylphenidate HCl in the OROS(R) delivery system) may be associated with a lower likelihood of abuse than immediate-release methylphenidate (sold as Ritalin(R)). The findings were presented today at a meeting of child and adolescent psychiatrists.

"The abuse of prescription stimulant medications is a growing concern among physicians who prescribe these medications to treat Attention Deficit Hyperactivity Disorder (ADHD) and parents of children and teens who rely on these treatments to restore normal function," said Edward Sellers, MD, PhD, an investigator on this study and Professor of Pharmacology, Medicine and Psychiatry at the University of Toronto. "Our study suggests that slowing the rate of drug delivery through the extended-release OROS(R) technology may decrease the likelihood of abuse."

The study, which evaluated 49 healthy adults with a history of light (occasional) recreational stimulant use, measured likeability using multiple scales which measured abuse-related effects, including Addiction Research Center Inventory, Drug Rating Questionnaire and Subjective Drug Value Procedure. These scales measured positive (liking or enjoyment), negative (dysphoric or disliking) and stimulant (related to reinforcement) effects. The study found that immediate-release methylphenidate produced greater subjective abuse-related effects than placebo and CONCERTA(R). In addition, a therapeutic dose of CONCERTA(R) (54 mg) was similar to placebo on most abuse-related measures tested. Overall, the study suggests that CONCERTA(R) is less likely to produce abuse-related subjective effects, such as "highs" or "euphoria", possibly due to a slower and extended rate of release of methylphenidate.

CONCERTA(R) has a unique formulation utilizing the OROS(R) technology that makes it less easily abused than other formulations of methylphenidate without compromising the effectiveness of the medication. The formulation of CONCERTA(R) is difficult to convert to an abusable form of methylphenidate. Under normal circumstances, the CONCERTA(R) tablet is difficult to crush, and the methylphenidate, the active ingredient in the CONCERTA(R) tablet, is difficult to extract.

Recently, the U.S. Department of Health and Human Services' Substance Abuse and Mental Health Services Administration (SAMHSA) invited McNeil Pediatrics to discuss data on the abuse profile of CONCERTA(R) as part of an information exchange session titled "Progress in Creating New Drug Formulations that Discourage Tampering and Abuse." Patrick E. Ciccone, M.D., Vice President of Medical Affairs at McNeil Pediatrics, presented data to support the low likelihood of abusing CONCERTA(R) due to its compromise-resistant formulation and gradual rate of absorption. Additionally, a study recently published in the American Journal of Psychiatry in March 2006 concluded that CONCERTA(R) may be less likely to be abused than immediate-release methylphenidate drugs. Study participants taking therapeutic oral doses of CONCERTA(R) did not report perceiving and enjoying the drug's subjective effects, features that are associated with a medication's potential for abuse.

For more information about CONCERTA(R), including full U.S. prescribing information, please visit http://www.concerta.net/ , call 1-888-440-7903 or contact your healthcare provider.

Important Safety Information

CONCERTA(R) should not be taken by patients with: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in CONCERTA(R); glaucoma; Tourette's syndrome, tics, or family history of Tourette's syndrome. Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if your child has had problems with alcohol or drugs, has had depression, abnormal thoughts or visions, bipolar disorder, seizures, high blood pressure or has had any heart problems or defects. If your child develops abnormal thinking or hallucinations, abnormal, extreme moods and/or excessive activity, or if aggressive behavior or hostility develops or worsens while taking CONCERTA(R), consult your healthcare professional. The most common adverse events reported in children receiving up to 54 mg were headache, upper respiratory tract infection and abdominal pain. The most common adverse events reported by adolescents receiving up to 72 mg were headache, accidental injury and insomnia.

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, CONCERTA(R) (methylphenidate HCl) Extended-release Tablets, is a once-a-day treatment for Attention Deficit Hyperactivity Disorder (ADHD) that uniquely combines methylphenidate with an exclusive OROS(R) delivery system. CONCERTA(R) is the number one ADHD prescribed medication in the U.S. for children and adolescents. The company is continuing to explore other new therapies to meet the special needs of children and the pediatric community.

Adderall(R) is a registered trademark of companies within the Shire group.

Ritalin(R) is a registered trademark of Novartis Pharmaceuticals Corp.

McNeil Pediatrics

CONTACT: Effie Delimarkos, +1-908-218-7542, Mobile +1-908-675-0152, orJulie Keenan, +1-908-704-4564, or Mobile +1-609-240-8590, both of McNeilPediatrics



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