Shire Announces FDA Approval Of Once-Daily INTUNIV trade; Extended Release Tablets For The Treatment Of ADHD In Children And Adolescents Aged 6 To 17
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today 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.
10 Grants Awarded By The Robert Wood Johnson Foundation Investigator Awards In Health Policy Research
In an effort to tackle major health policy issues in the United States, the Robert Wood Johnson Foundation® (RWJF) has announced the selection of this year's recipients of its Investigator Awards in Health Policy Research. Sixteen scholars affiliated with major universities across the country will receive funding to support 10 new research projects. The winning researchers are tackling a wide range of health policy issues such as ways to treat children with Attention-deficit hyperactivity disorder ( ADHD ) more effectively and improve their quality of life; the way we define and assess risk for developing Alzheimer's Disease; consumer understanding of health claims made about food and beverages; the connections between child and adult health; and the politics surrounding research that compares the effectiveness of medical treatments. "This program stimulates thinking that is creative and crosses disciplinary boundaries in search of solutions to vexing issues affecting health and health care in the United States, " says David Mechanic, Ph.
Antisocial and aggressive behaviours represent a widespread and expensive social problem. Recent research has convincingly shown that there is a strong interaction between genetic inheritance and environment for development of personality and behaviour. It appears to be common knowledge that childhood maltreatment often causes psychiatric problems (e.g. depression or anxiety ) or behavioural problems (e.g. aggression or antisocial behaviour) later in life. The risk for such a development is, however, different between individuals and can to a large extent be explained by genetic factors. The identification of neural mechanisms underlying human personality and temperament seems to be promising due to their considerable importance as highly heritable risk mediators for aggressive behaviour, criminal activity, as well as somatic and psychiatric disorders (Buckholtz et al., 2008; Buckholtz & Meyer-Lindenberg, 2008; Nilsson et al., 2006). MAOs: key molecules for personality and behaviour Monoamine oxidases (MAOs) are two enzymes (MAO-A and MAO-B) which inactivate the so called monoamine transmitter substances serotonin, noradrenalin and dopamine.
Results from brain scans suggest an association between a reduction in the transmission of dopamine markers with symptoms of inattention for individuals with attention deficit/hyperactivity disorder ( ADHD ), according to a preliminary study in the September 9 issue of JAMA. ADHD is a childhood psychiatric disorder that frequently persists into adulthood, and is estimated to affect 3 percent to 5 percent of the U.S. adult population, which makes it one of the most prevalent of all psychiatric disorders, according to background information in the article. Previous research has indicated that dopamine (a neurotransmitter essential for the normal functioning of the central nervous system) transmission is disrupted in some pathways of the brain in ADHD. Nora D. Volkow, M.D., of the National Institute on Drug Abuse, Bethesda, Md., and colleagues conducted a study to determine whether there are abnormalities in the mesoaccumbens (site of the dopamine reward pathway in the mid-brain) in patients with ADHD.
A panel of physicians and scientists will report on the benefits of a simple meditation practice for aiding students diagnosed with ADHD during a national medical webinar, which will be hosted by the David Lynch Foundation on Wednesday, September 30, 12 noon (ET). http://www.adhd-tm.org/ The webinar, which comes on the final day of National ADHD Public Awareness Month, will report on published research on the effects of the Transcendental Meditation technique for improving academic achievement and executive brain function while reducing learning disorders, anxiety, depression, metabolic syndrome, diabetes, and heart disease. Conference panelists Sarina Grosswald, Ed.D. George Washington University-trained cognitive learning specialist; lead researcher on a pioneering study on the Transcendental Meditation technique and ADHD; and Executive Director of the David Lynch Foundation's Office of ADHD and Other Learning Differences. Norman E. Rosenthal, M.D. Senior Researcher in Psychiatry and Psychobiology for 20 years at the National Institute of Mental Health;
Attention deficit/hyperactivity disorder, ADHD, is one of the most common neuropsychiatric disorders of childhood. Worldwide, 3% of children are affected with the disorder. Key symptoms of ADHD include age-inappropriate hyperactive and impulsive behaviour and/or a reduced ability to focus attention. Clinically, three different ADHD subtypes are classified, a primarily inattentive subtype, a primarily hyperactive/impulsive subtype, and a combined subtype in which patients show deficits in both domains. At the level of the brain, small aberrations in both structure and activity of specific brain regions, as well as the connectivity between brain regions have been observed in children and adults with ADHD (Valera et al., 2007; Schneider et al., 2006; Makris et al., 2008; Pavuluri et al., 2009; Broyd et al., 2009). Although ADHD has classically been viewed as a disorder of children, more than half of the patients carry symptoms, or even the full ADHD-diagnosis, into adulthood (Faraone et al.
In an effort to help one of the most under studied groups of sufferers of attention deficit hyperactivity disorder ( ADHD ), researchers at University of Rhode Island and Lehigh University have kicked off the first-ever controlled pharmacological study for treatment of ADHD amongst college students. The study is being conducted by Lisa Weyandt, associate professor of psychology at University of Rhode Island (Kingston, RI) and George DuPaul, professor of school psychology and chair of the department of education and human services at Lehigh University (Bethlehem, PA), with funding from Shire Development Inc. Approximately 2 to 4 percent of college-age students report significant symptoms of ADHD such as difficulty with attention, impulse control and restlessness. ADHD is one of the most common disorders of childhood, but symptoms of ADHD often linger into adulthood. Relative to the body of information available regarding childhood ADHD, less is known about ADHD in adults, and even less is known about college students with ADHD.
When they think of attention deficit hyperactivity disorder, most people think of squirming kids unable to sit still. ADHD, as it is more generally known, is one of the most common disorders of childhood. But symptoms of ADHD often linger into adulthood. Approximately 2 to 4 percent of college students report significant symptoms of ADHD such as difficulty with attention, impulse control, and restlessness. Although there is a great deal of information about childhood and adult ADHD and treatments, there's scarce information about the effectiveness of medication on college students with ADHD. That is all about to change. Researchers at the University of Rhode Island and Lehigh University are about to launch a study to test the effectiveness of the stimulant medication, Vyvanse ™ , on college students with ADHD. It is the first such study for this population. Lisa Weyandt, an associate professor of psychology at URI and one of the nation's leading researchers on ADHD in college students, was awarded a grant from Shire Development Inc.
It has long been suggested that healthy folate (the natural form of folic acid) levels in expectant mothers goes hand in hand with healthy nervous system development in their children. A study published in an upcoming issue of The Journal of Child Psychology and Psychiatry finds that low maternal folate levels is linked to the development of attention-deficit/hyperactivity problems in children at age seven to nine years. Researcher Dr. Wolff Schlotz points out, "Our findings further support the hypothesis that maternal nutrition contributes to an individuals' development, with potential consequences for their behavior later in life." The long term effects of poor maternal nutrition may even branch out to the child's ability to interact with peers or form social bonds. The researchers also found that children born from mothers with a low folate status had a notably smaller head circumference at birth, which may indicate a smaller rate of prenatal brain growth in children adversely affected by low folate levels.
Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder ( ADHD ). The submission is based on the successful completion of Phase III clinical trials demonstrating statistical significance when Clonicel was used to treat ADHD in children and adolescents. "The sNDA filing for Clonicel is an important milestone for physicians and the millions of patients and their families seeking a non-stimulant alternative for the treatment of ADHD, " said Moise Khayrallah, PhD, Chief Executive Officer of Addrenex Pharmaceuticals. "For Addrenex, this filing is another exciting accomplishment in our company's brief history, further validating our drug development model in bringing new drugs to market to fill unmet needs." Clonicel is the company's lead compound in a pipeline of products targeting conditions arising from an overactive adrenergic system, the body's control center for regulating stress and a host of other physiologic functions.