FDA Approves Labeling Change For VYVANSE CII To Efficacy At 13 Hours Postdose In Children With ADHD
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder ( ADHD ) treatment VYVANSE ® (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.5 hours) through 13 hours postdose. VYVANSE is now the first and only oral ADHD stimulant treatment to have 13-hour postdose efficacy data for pediatric patients included in its product labeling.
FDA Approves VYVANSE CII Label Change To Include Supplementary Clinical Data Supporting Efficacy At 13 Hours Postdose In Children Age 6-12 With ADHD
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder ( ADHD ) treatment VYVANSE ® (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.5 hours) through 13 hours postdose. VYVANSE is now the first and only oral ADHD stimulant treatment to have 13-hour postdose efficacy data for pediatric patients included in its product labeling.
InfoMedics Presents Studies Highlighting Adults' Experiences With ADHD Drug
InfoMedics, Inc., the patient feedback company, recently co-authored two posters detailing patients' experiences with the attention-deficit/hyperactivity disorder ( ADHD ) drug lisdexamfetamine dimesylate (LDX). The posters were presented at the American Psychiatric Association (APA) and the College of Psychiatric and Neurologic Pharmacists' (CPNP) annual meetings. Both presented data gathered through the Vyvanse New Start Program, which provides information to prescribing physicians about patients' impressions of LDX treatment and its affect on their ADHD symptoms. "The New Start Program is designed to support effective patient-physician communications, " said InfoMedics' Senior Director of Analytic Services Donna Kerney, PhD.
University Of Central Lancashire To Deliver Nurtured Heart Workshop, UK
Residential childcare and fostering agency, Perpetual Care, and the University of Central Lancashire's School of Nursing & Caring Sciences are jointly developing an introductory workshop on the ground-breaking Nurtured Heart Approach, which seeks to improve social and educational outcomes for many children and young people. Experts from UCLan and Perpetual are currently designing an awareness workshop, which will provide an overview of the approach, examine existing US research findings and explore its potential role in UK residential childcare and fostering, particularly in the light of revised NICE guidelines relating to children with ADHD. The first session is scheduled at UCLan's Preston campus in late June this year and should be of interest to registered social workers, local authority placement officers and other social care and health professionals concerned with the well-being of challenging young people.
FDA Issues Safety Communication About An Ongoing Review Of Stimulant Medications Used In Children With ADHD
There may be an association between the use of stimulant medications for attention-deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children, according to a study published in the American Journal of Psychiatry. But the U.S. Food and Drug Administration says that, because of the study's limitations, parents should not stop a child's stimulant medication based on the study. The FDA recommends that parents should discuss concerns about the use of these medications with the prescribing health care professional. The FDA can not conclude that the data in the study affect the overall risk-benefit profile of stimulant medications used to treat ADHD in children.
Study Links ADHD Drugs To Sudden Death In Children
A new study by researchers in the US suggests there may be a link between the use of stimulant drugs for attention-deficit hyperactivity disorder ( ADHD ) and sudden cardiac death in healthy children, but the US Food and Drug Administration (FDA), who funded the study with the National Institute of Mental Health, said because of its limitations, parents and carers should not stop giving children such medication on the basis of this study but should discuss any concerns with their prescribing doctor. The study was the work of lead author Dr Madelyn S Gould of Columbia University, New York, New York, and colleagues, and is published in the 15 June issue of the American Journal of Psychiatry.
Do ADHD Drugs Cause Sudden Death?
This week, a study came out that scared us big-time ... it suggests that children and teens who take stimulants like Ritalin for ADHD have an increased risk for sudden cardiac death. Our pediatrician weighs in. A new study in The American Journal of Psychiatry suggests that children and teens who take stimulants like Ritalin for ADHD have an increased risk for sudden cardiac death. Researchers collected data on stimulant use among 564 children and teenagers who died unexpectedly of unknown causes and an equal number who died as passengers in auto accidents. Many of the unexplained deaths were later attributed to previously undiagnosed cardiac arrhythmias. They concluded that the odds of using stimulant medication were six to seven times greater among the children who died suddenly of unexplained causes than among those who died in car crashes.
ADHD Genes Found; Known To Play Roles In Neurodevelopment
Pediatric researchers have identified hundreds of gene variations that occur more frequently in children with attention-deficit hyperactivity disorder ( ADHD ) than in children without ADHD. Many of those genes were already known to be important for learning, behavior, brain function and neurodevelopment, but had not been previously associated with ADHD. "Because the gene alterations we found are involved in the development of the nervous system, they may eventually guide researchers to better targets in designing early intervention for children with ADHD, " said lead author Josephine Elia, M.D., a psychiatrist and ADHD expert at The Children's Hospital of Philadelphia.
New Goal To Get More People With Learning Disabilities Into Work, UK
People with a learning disability will be helped into paid jobs to close the employment gap, Jonathan Shaw, Minister for Disabled People and Phil Hope, Minister for Care Services pledged today. The goal is set out in the new cross-government Learning Disability Employment Strategy, published today. The strategy sets out a vision to increase the number of real jobs for people with learning disabilities with appropriate support being provided. Care Services Minister Phil Hope said: "Two thirds of people with a learning disability would like to work. Huge progress has been made in getting physically disabled people into employment but more must be done to help people with a learning disability - we're missing a huge talent pool which employers can tap into.
VYVANSE CII Provided Significant Efficacy At 14 Hours After Administration In Adults With ADHD In An Adult Simulated Workplace Environment
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced results from a Phase 3b study that found VYVANSE ® (lisdexamfetamine dimesylate) CII demonstrated significant efficacy at 14 hours after administration during a simulated workplace environment study in adults with Attention Deficit Hyperactivity Disorder ( ADHD ). VYVANSE is the first approved stimulant for adults with ADHD to be evaluated in this setting, and these data were presented today at the 49th annual New Clinical Drug Evaluation Unit meeting in Hollywood, FL. VYVANSE is currently approved by the US Food and Drug Administration (FDA) for the treatment of ADHD in children age 6 to 12 years and in adults with ADHD.