Best Practice Guidelines On Identifying And Treating ADHD

The American Academy of Child and Adolescent Psychiatry (AACAP) is proud to announce its new Practice Parameter and Pocketcard on attention-deficit hyperactivity disorder (ADHD). The Practice Parameter represents best practices in evaluating and treating ADHD and the pocketcard is the document’s portable summary. Both the Parameter and Pocketcard were designed to teach health care professionals about the disorder.

AACAP’s Practice Parameter shows that ADHD is a medical illness on par with diabetes or asthma. Like these conditions, ADHD can be successfully managed, but not cured. Left untreated, children with ADHD often experience failure at school, problems at home, substance abuse, and depression.

AACAP’s Practice Parameter presents the effects, including the long-term data, of treating ADHD with and without medication. Although medications must be balanced against rare adverse reactions, the safety of ADHD medicinal treatment is equal to other pediatric conditions.

In addition to updating mental health professionals, the Practice Parameter and Pocketcard will teach health care professionals who do not specialize in mental health about ADHD. As there is a shortage of child and adolescent psychiatrists, most youth with ADHD who receive treatment obtain it from their pediatricans or general practictioners.

The AACAP is a medical association committed to supporting its members’ research on ADHD. Families interested in learning about the disorder should view the video, ADHD, A Guide for Families, and read the AACAP Facts for Families, The Child Who Can’t Pay Attention.

Representing over 7,500 child and adolescent psychiatrists nationwide, the American Academy of Child and Adolescent Psychiatry (AACAP) is the leading authority on children’s mental health.

Mission of the AACAP

Promote mentally healthy children, adolescents and families through research, training, advocacy, prevention, comprehensive diagnosis and treatment, peer support and collaboration.

http://www.aacap.org

ADHD Medication Being Discontinued By Many Children

Social stigma and feeling lifeless and/or alienated from one’s peers are some of the reasons why children and adolescents stop taking prescription stimulant medications used to treat attention deficit-hyperactivity disorder (ADHD), according to a new study published in the Journal for Specialists in Pediatric Nursing.

ADHD is a common neurobehavioral disorder, affecting 4.4 million children in the United States between the ages of 4 and 17. Following diagnosis, 56% are treated with prescription stimulant medications. According to the study, many stop using these medications even while they are still exhibiting symptoms of the disorder, despite research indicating these medications are effectively reducing hyperactivity, impulsivity and inattention.

The study also found that while ADHD is a chronic disorder, none of the adolescents interviewed had received ongoing education about their condition. As college students, many used the medications irregularly, sometimes in doses exceeding the prescribed amount, and often at night – factors that may exacerbate the side effects.

Julie B. Meaux, PhD, RNC, lead author of the study, suggests that “dialogue between the child, parents and healthcare provider about the general effects, side effects and potential abuse of prescribed stimulant medications is essential,” adding “careful administration of dosages, based on input from the child, is exceedingly important.”

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This study is published in the current issue of the Journal for Specialists in Pediatric Nursing.

Julie B. Meaux, PhD, RNC is an Assistant Professor in the Department of Nursing at University of Central Arkansas.

Novel Treatment For ADHD

Shire plc and its collaborative partner New River Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance. This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007. VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d -amphetamine is covalently linked to l -lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d -amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication’s unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.

Additional information about VYVANSE and other Shire treatments for ADHD is available at http://www.ShireADHDTreatments.com.

VYVANSE Significantly Controls ADHD Symptoms

Data from phase II and phase III clinical trials demonstrated statistically significant improvements in ADHD symptoms for patients aged 6 to 12 years treated with VYVANSE compared to patients treated with placebo. These studies demonstrated that all doses of VYVANSE (30 mg, 50 mg and 70 mg) provided significant efficacy at all time points tested, including 6pm.

In the phase II, analog classroom study, patients demonstrated significantly improved behavior when receiving either VYVANSE or ADDERALL XR ® (mixed salts of a single-entity amphetamine product) as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment rating scale, a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD. Both treatments resulted in significantly improved behavior versus a placebo ( P

FDA Directs ADHD Drug Manufacturers To Notify Patients About Adverse Reactions

The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). “In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns.”

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

– Adderall (mixed salts of a single entity amphetamine product) Tablets

– Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules

– Concerta (methylphenidate hydrochloride) Extended-Release Tablets

– Daytrana (methylphenidate) Transdermal System

– Desoxyn (methamphetamine HCl) Tablets

– Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets

– Focalin (dexmethylphenidate hydrochloride) Tablets

– Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules

– Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules

– Methylin (methylphenidate hydrochloride) Oral Solution

– Methylin (methylphenidate hydrochloride) Chewable Tablets

– Ritalin (methylphenidate hydrochloride) Tablets

– Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets

– Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules

– Strattera (atomoxetine HCl) Capsules

The draft Patient Medication Guides for each product can be found at: http://fda.gov/cder/drug/infopage/ADHD/default.htm