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McNeil Pediatrics Presents Data On CONCERTA(R) (Methylphenidate HCl) Formulation


7/18/2006 10:52:34 AM

FT. WASHINGTON, Pa., July 17 /PRNewswire/ -- McNeil Pediatrics, a division of McNeil-PPC, Inc., was invited by the U.S. Department of Health and Human Services' Substance Abuse and Mental Health Services Administration (SAMHSA) to present data today on CONCERTA(R) (methylphenidate HCl) Extended-release Tablets as part of an information exchange on "Progress in Creating New Drug Formulations that Discourage Tampering and Abuse."

"McNeil Pediatrics is pleased to have the opportunity to discuss the OROS(R) technology of CONCERTA, as this unique formulation makes it less easily abused than other formulations of methylphenidate," said Patrick E. Ciccone, M.D., vice president, Medical Affairs, McNeil Pediatrics. "Our company is committed to the development of safe and effective products, and is proud of the creation and application of important new technologies that encourage appropriate use."

SAMHSA held an Open Dialogue Meeting today to discuss abuse, misuse and tampering issues related to prescription drugs. Similar to many other classes of medications, there is potential for abuse of stimulants that are used to treat Attention Deficit Hyperactivity Disorder (ADHD). As part of the SAMHSA forum, McNeil Pediatrics was invited to present data on its ADHD product, CONCERTA.

During the presentation, Dr. Ciccone explained how the unique formulation of CONCERTA is difficult to convert to an abusable form of methylphenidate. Under normal circumstances, the CONCERTA tablet is very difficult to crush, and the methylphenidate in the tablet is difficult to extract. In fact, after being subjected to multiple methods of potential abuse, CONCERTA tablets cannot be uniformly reduced to a powder-like substance. It is only under harsh conditions that the tablet can be broken. Even when taken as directed, the medication does not release from the tablet all at once; rather, the OROS technology provides a slow rate of drug delivery throughout the day, which decreases the likelihood of abuse without compromising the effectiveness of the medication.

Multiple studies have been conducted illustrating the effectiveness and safety of CONCERTA. Additionally, a study recently published in the American Journal of Psychiatry in March 2006 concluded that CONCERTA may be less likely to be abused than other immediate release methylphenidate drugs. Study participants taking therapeutic oral doses of CONCERTA 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, 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 should not be taken by patients with: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in CONCERTA; 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, 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 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.

McNeil Pediatrics

CONTACT: Julie Keenan, Office: +1-908-704-4564, Mobile: +1-609-240-8590;Effie Delimarkos, Office: +1-908-218-7542, Mobile: +1-908-675-0152, both ofMcNeil Pediatrics



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