Health and Fitness

Vyvanse CII Significantly Improved ADHD Symptoms For Children 13 Hours After Administration

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse ® (lisdexamfetamine dimesylate) CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder ( ADHD ) in children aged 6 to 12 from the first time point measured (1.5 hours) up to the last time point assessed (13 hours) after administration. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention in children at each time point measured, with improvement at 13 hours after administration. "Pediatric patients may require ADHD symptom improvement both at school and after school, " said Sharon Wigal, PhD, lead investigator of the study, clinical professor of pediatrics and director of clinical trials in the Child Development Center at the University of California, Irvine.

FDA Issues Complete Response Letter For INTUNIV TM guanfacine Extended Release For The Treatment Of ADHD In Children And Adolescents

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter for INTUNIV(TM) (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. The FDA did not identify safety concerns regarding INTUNIV in the Complete Response letter or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4 to 8 weeks. "Shire is confident that we will quickly come to agreement on the final product label and anticipates a launch in the fourth quarter as planned, " said Mike Cola, President of Shire Specialty Pharmaceuticals. "When approved, INTUNIV will be the first selective alpha-2A receptor agonist for the treatment of ADHD, and will provide patients with an important new treatment option." About INTUNIV INTUNIV is being studied for the treatment of ADHD in children and adolescents aged 6 to 17 years.

FDA Issues Complete Response Letter For INTUNIV trade; guanfacine Extended Release For The Treatment Of ADHD In Children And Adolescents

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter for INTUNIV TM (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. The FDA did not identify safety concerns regarding INTUNIV in the Complete Response letter or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4 to 8 weeks. "Shire is confident that we will quickly come to agreement on the final product label and anticipates a launch in the fourth quarter as planned, " said Mike Cola, President of Shire Specialty Pharmaceuticals. "When approved, INTUNIV will be the first selective alpha-2A receptor agonist for the treatment of ADHD, and will provide patients with an important new treatment option." About INTUNIV INTUNIV is being studied for the treatment of ADHD in children and adolescents aged 6 to 17 years.

Study Demonstrated Once-Daily Vyvanse R CII Provided Significant Improvement Of ADHD Symptoms For Children At 13 Hours After Administration

Shire plc announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse ® (lisdexamfetamine dimesylate) CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder ( ADHD ) in children aged 6 to 12 from the first time point measured (1.5 hours) up to the last time point assessed (13 hours) after administration. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention in children at each time point measured, with improvement at 13 hours after administration. "Pediatric patients may require ADHD symptom improvement both at school and after school, " said Sharon Wigal, PhD, lead investigator of the study, clinical professor of pediatrics and director of clinical trials in the Child Development Center at the University of California, Irvine. "These published data are the first to have shown duration of effect of an oral ADHD stimulant in children aged 6 to 12 at 13 hours after administration.

Study Demonstrated Once-Daily Vyvanse reg; CII Provided Significant Improvement Of ADHD Symptoms For Children At 13 Hours After Administration

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse ® (lisdexamfetamine dimesylate) CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder ( ADHD ) in children aged 6 to 12 from the first time point measured (1.5 hours) up to the last time point assessed (13 hours) after administration. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention in children at each time point measured, with improvement at 13 hours after administration. "Pediatric patients may require ADHD symptom improvement both at school and after school, " said Sharon Wigal, PhD, lead investigator of the study, clinical professor of pediatrics and director of clinical trials in the Child Development Center at the University of California, Irvine.

Do Brain Waves Run Our Attention Clock?

New research from the US suggests that when we look for something in our environment, our attention scans one thing at a time, using a serial as opposed to a parallel process whose clock speed is controlled by brain waves or "neuron population oscillations". Thus next time you arrange to meet a friend in a crowded bar or restaurant, remember that your attention searches the room like a superfast spotlight, pausing on each face for only 1/25th of a second, before settling on the one familiar to you, or at least that is what postdoctoral associate Timothy J Buschman, and Picower Professor of Neuroscience Earl Miller suggest in a paper published in the 13 August online issue of the journal Neuron. Both authors are from the Picower Institute for Learning and Memory and Department of Brain and Cognitive Sciences at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts. The control of attention, the process that manages the information that floods in via our senses, is somewhat of a mystery, yet if we knew more about it, we might also find out more about cognition, or what happens when we think about what the information coming in through our senses is telling us.

Back-to-School Resource From American Public University For Teachers, Counselors: 'Tips' Cards On ADD ADHD, Bullying, Child Abuse, Teen Depression

"Tips for Teachers" cards on key behavioral and student wellness issues are available at no cost to teachers, counselors, principals and other school-based personnel, thanks to a program by American Public University, a member institution of American Public University System, an accredited, online university system that serves more than 50, 000 working adults studying worldwide. Laminated, 6" x 8" cards are available featuring information from expert sources on how to recognize and help students who may be suffering from these conditions and/or situations: - Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD) - Bullying - Child abuse and neglect - Teen depression and suicide The "Tips for Teachers" cards have many uses, including as a classroom resource, for professional training, as part of "welcome back" teacher packets, as a resource for parents, and as a resource to help satisfy school district- or state-mandated training requirements. Teachers, administrators and schools may order the cards at no cost by visiting studyatapu.

More Kids Using ADHD Drugs To Get High

Attention-deficit/hyperactivity disorder ( ADHD ) affects between 8 percent and 12 percent of children and 4 percent of adults worldwide. There has been a significant increase in the use of prescription stimulants to treat ADHD. The most frequently prescribed ADHD medications include mixed amphetamine salts and methylphenidate. The study, "Adolescent Prescription ADHD Medication Abuse is Rising Along With Prescriptions for These Medications, " analyzed the American Association of Poison Control Center's National Poison Data System for the years 1998 to 2005 for all cases involving 13- to 19-year-olds who intentionally abused or intentionally misused ADHD prescription medication. Calls related to ADHD medication abuse rose 76 percent, to 581 from 317 each year. Estimated prescription rates for teens and preteens increased 133 percent for amphetamine products, 52 percent for methylphenidate products, and 80 percent for both together. Although the majority of adolescents use their ADHD medication appropriately, pediatricians need to know that the increase in prescriptions of ADHD medication increases the potential for abuse.

Shire Announces FDA Approval Of Once-Daily INTUNIV TM guanfacine Extended Release Tablets For The Treatment Of ADHD In Children And Adolescents

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder ( ADHD ) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD. Although the mechanism of action is unknown, INTUNIV is thought to directly engage receptors found in the prefrontal cortex an area of the brain that has been linked in preclinical research to ADHD. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control. "Shire is proud to introduce INTUNIV, providing clinicians, patients, and their families with a novel ADHD treatment option, " said Mike Cola, President of Shire Specialty Pharmaceuticals.

INTUNIV Guanfacine Extended Release Tablets For ADHD In Children And Adolescents Approved By FDA

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV™ (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder ( ADHD ) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD. Although the mechanism of action is unknown, INTUNIV is thought to directly engage receptors found in the prefrontal cortex - an area of the brain that has been linked in preclinical research to ADHD. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control. "Shire is proud to introduce INTUNIV, providing clinicians, patients, and their families with a novel ADHD treatment option, " said Mike Cola, President of Shire Specialty Pharmaceuticals.

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