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Isaac M.,European Medicines Agency EMEA | Isaac M.,Kings College London | Koch A.,European Medicines Agency EMEA | Koch A.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Koch A.,Hannover Medical School
European Neuropsychopharmacology | Year: 2010

In this paper we investigate mortality in short-term placebo-controlled trials conducted to demonstrate efficacy and safety of atypical antipsychotic drugs for the treatment of schizophrenic patients in the acute phase of illness. Arguments are provided, why short-term placebo-controlled studies are required. This is an integrated analysis of results from randomized placebo-controlled trials conducted pre-licensing for risperidone, olanzapine, quetiapine IR, ziprasidone, risperidone consta, aripiprazole, paliperidone, and quetiapine XR. Information was retrieved from study publications, EPAR, and from the FDA SBA, all in the public domain. 7553 patients were randomized in the remaining 23 short-term acute phase clinical trials. 2/5738 patients died after having been randomized to an active treatment. 5/1815 died in the placebo group. The crude odds-ratio for an increased death risk with placebo treatment is 7.92 (95% confidence interval (1.45 to 40.87), two sided P = 0.0134). Death narratives show: (i) both deaths in active treatment groups occurred during randomized treatment period, (ii) two deaths in the placebo group of a trial in the elderly were observed in patients with severe co-morbidities not usually included in a randomized trial, and (iii) two further deaths in the placebo groups occurred 9 and 23 days after the end of the randomized treatment period. Under these circumstances the crude odds-ratio for an increased risk of death for patient with placebo as compared to active treatment is 1.58 (95% confidence interval (0.14-17.45), two sided P = 0.71). Confidence intervals are generally wide indicating a still limited knowledge about a potential increase in mortality with placebo treatment. Unless, however, society is willing to take the risk that ineffective drugs are licensed and cause undetected harm thereafter, or is willing to restrict licensing to drugs that are superior to current treatments, short-term placebo-controlled trials in the acute phase of schizophrenia are necessary. Measures are proposed to minimize risks. © 2010 Elsevier B.V. and ECNP.

Weiergraber M.,Bundesinstitut For Arzneimit Tel Und Medizinprodukte Bfarm | Broich K.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm
Psychopharmakotherapie | Year: 2011

Neuroenhancement, mood enhancement and mind-doping are part of a complex social development of the 21st century, demanding for a careful and integrative medicinal discussion. The goal of this overview is to illustrate the various aspects of mind-doping, its medical history, epidemiology, the underlying motivations, the neurophysiological background and pharmacological and regulatory issues related to active substances involved. A specific focus is put on the ethical implications of neuro- and mood enhancement. The pros and cons of mind-doping need to be balanced carefully and a social consensus is clearly inevitable for a responsible handling of cognitive and mood enhancers in the future.

Norwig J.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | Year: 2014

According to the EU Directive 2001/83 the European Pharmacopoeia is the official Pharmacopoeia of the European Union. Therefore the European Pharmacopoeia is one of the legal pharmacopoeial compendia in Germany. Any licensed medicinal product on the German market complies with the requirements of the compendial monographs, if applicable. Because the general monographs of the European Pharmacopoeia on Dosage Forms, Substances for Pharmaceutical Use and Pharmaceutical Preparations refer to the microbiological and biological methods of the Pharmacopoeia, the methods are relevant for medicinal products, too. This article presents a rough summary of the microbiological and biological methods of the European Pharmacopoeia and is intended to be a stimulus for the reader to better understand the original compendia. The short description of the methods mentioned, here, is a summary from the Pharmacopoeia and the non-official collection of comments on the texts of the European Pharmacopoeia. © 2014, Springer-Verlag Berlin Heidelberg.

Crommelin D.J.A.,University Utrecht | Broich K.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Holloway C.,Chief Scientific Officer of ERA Consulting GmbH | Meesen B.,Ismar Healthcare | And 3 more authors.
Multiple Sclerosis | Year: 2016

Background: Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product. Objective: The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments. Conclusion: Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients. © SAGE Publications.

Afentaki A.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Afentaki A.,University of Duisburg - Essen
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | Year: 2014

Regulation EC 1901/2006, better known as the "Paediatric Regulation," targets the challenging aim of improving the supply of pharmaceutical products for children and adolescents living in Europe. In order to counteract the much-debated and long-standing problem of "off-label" use within paediatrics, the Paediatric Regulation established two new paediatric procedures in order to increase the number of medicines licensed for children in future. This article reports on the outcomes of these procedures, covering the period from 2007 to the present. The aim was to find out how many substances underwent the paediatric procedures and how many medicinal products have been approved explicitly for children as a result. In the second part, a prioritized off-label analysis was conducted focusing on the top 100 substances most frequently prescribed to children and adolescents in Germany in 2011. The top 100 substances consist of the respective top 20 substances of five therapeutic areas. The prescription scores are based on the GAmSi project of the National Association of the Statutory Health Insurance of Germany. The rankings refer to outpatient care and cover the statutory health-insured paediatric population of Germany below 18 years of age, divided into two age groups, children and adolescents. In order to investigate whether the most frequently prescribed substances are labelled for paediatric use, 200 SmPCs were screened and evaluated (cut-off date: 31 December 2012). In a final step, the relation between the top 100 substances and the Paediatric Regulation was examined. For this purpose, it was investigated whether the listed substances are or have been subject to the paediatric procedures in order to identify potential positive impacts of the Paediatric Regulation. © 2014 Springer-Verlag Berlin Heidelberg.

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