EMA, Publishes Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

EMA, Publishes Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

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Attention Deficit Hyperactivity Disorder (ADHD) is among the most common disorders in child- and adolescent psychiatry. Its impact on learning and development is considered substantial. The benefit of pharmacotherapy has empirically been proven, and several products are on the market. Although primarily a disorder diagnosed in childhood and adolescence, signs and symptoms may not be selflimiting but may persist into adulthood. These new insights in the ADHD syndrome are a challenge in the field of drug development. However, this Guideline is intended to provide guidance on the evaluation of new medicinal products in ADHD with focus on the childhood onset. It is the first guideline written in psychiatry to address a (child) psychiatric disorder from this perspective, and it should be read in conjunction with other EMA and ICH  guidelines, which may apply to similar conditions and patient populations.

Attention Deficit Hyperactivity Disorder, ADHD, is a well defined disorder with core features of inattention, hyperactivity, and impulsivity, but also impairment in executive functions. It has its origin in childhood and is often diagnosed for the first time in school-aged children because of learning problems and problems with social behaviour. Treatment is therefore directed towards improvement of attention and reduction of hyperactivity/impulsivity in order to be able to focus on tasks and performance, and improve associated behavioural and relational problems. Methylphenidate is among the first effective drugs reported to treat the ‘hyperkinetic syndrome’ in the 1950s.  Although often regarded as the standard of treatment, new products have come to the market, e.g. atomoxetine with a different mode of action. Psycho-education, and psycho-education in combination with pharmacotherapy are usually the standard of care in Europe, and behavioural treatment is often provided to sustain success of pharmacotherapy, and to modify conduct problems. In the context of non-pharmacological interventions, cognitive treatment, neurofeedback training and dietary  measures can be regarded as potential, but not yet evidence based strategies. It has long been assumed that the core symptoms of ADHD ameliorate with age. It has recently been recognized that symptoms and impairments may persist into adulthood, thereby extending treatment to this age group. Usually, inattention and restlessness predominate at adult age, interfering with work and social functioning. As ADHD is a chronic disorder, long term treatment can be foreseen, thereby emphasizing the need for
long term safety data in a group of patients that does include many otherwise healthy individuals.

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Damien Bové is the drug development and regulatory consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.


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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”