Masterarbeit

History of attention deficit and hyperactivity disorder linked to Methylphenidate: A regulatory overview of the product lifecycle

Monica Cano (2017)

Summary
Language: English
With the interest for a mental disorder, widely described, but not always sufficiently understood, the disease Attention deficit and hyperactive disorder (ADHD) has become not only the focus of advances in the neurological, psychological diagnosis and pharmacotherapy, but also the reason for controversial views since 1798 up to now.
Starting with the illustrations of a fidgety son not able to sit or to attend and with a motoric overactivity in the known storybook "Struwwelpeter" (Fidgety Phil) issued by the German physician Heinrich Hoffmann in the late nineteenth century, the image of today´s ADHD was addressed for the first time.
Nowadays, ADHD is recognized as one of the most common neurobehavioral disorder whose key behaviours are inattention, hyperactivity and impulsivity, affecting 3-10% of children and 2-5% of adolescents and adults.
It was only thanks to Bradley´s observations on amphetamines in 1937 that a strategy for treatment was visualized for the first time: medication to calm children´s behaviour and at the same time to offer the ground for psychotherapy. It took many, many years until an alternative to the amphetamines was discovered and Methylphenidate (MPH), "Ritalin®", today´s first choice of treatment of hyperactive children, was born. In the course of time, the disorder was more and more understood and even acknowledged to be present in the adult population. Thus, the pharmacological therapy was extended to adults. Thus, for example in Germany, since 2011 MPH is also authorized for treatment in adults.
This dissertation gives an overview of the history and current approach to ADHD and of the development of the pharmacotherapy with MPH. It presents the lifecycle of the medicinal product, including the extension to approve the treatment of adults and the approved product information, as an instrument of pharmacovigilance.
The approval of new indications of a medicinal product is a common instrument to either introduce or even to re-introduce medicinal products into the market. This practice is exemplified with the help of two recognised medicinal products: memantine and thalidomide. The lifecycle of both products is presented briefly, in order to illustrate the new indications granted in the course of time
Pages: 65, Annexes: 39 pages