Relevant information about our clinical development activities is provided below. At Desitin, we are proud of the fact that for decades we have consistently produced global innovations that have considerably improved and simplified drug treatment for doctors and patients, and have already become standard treatments. These innovations, which were and are always developed in close cooperation with leading experts and treatment centres, are the basis of our success and our reputation among health professionals, pharmacists, patients and other businesses in the pharmaceutical industry. A list of our most important developments can be found under the Innovations section.
As well as recognised expertise in the area of product development, conducting clinical studies is an essential step on the path of a new product to doctor and patient. In its clinical development department, Desitin has extensive expertise in carrying out phase I, III and IV clinical studies.
In clinical development, all innovations from our product development undergo extensive clinical testing based on the latest standards. Our work focuses on epilepsy and Parkinson’s Disease. As well as bioavailability studies and medicinal product interaction studies, we concentrate on multi-centre studies of the efficacy and tolerability of our medicinal products. In doing so, we work closely with renowned hospitals and contract research organisations.
Some of our most important projects are presented below.
Recently, two Phase I bioequivalence studies with an innovative oral dosage form of a new-generation anti-epileptic, developed by Desitin, were completed.
In cooperation with a total of eleven German hospitals specialising in Parkinson’s Disease, an open, randomised, parallel-group, phase III study of the non-ergot dopamine agonist Clarium (active substance: piribedil) has been commenced (PiViCog-PD). The aim is to compare piribedil with standard therapies for its effect on cognitive and alertness parameters in a total of 76 patients.
In addition, concomitant post-marketing non-interventional studies (NIS) of tolerability and safety are being conducted. We recently completed two NIS projects with our Parkinson’s Disease product Clarium. In June 2009 we commenced a third NIS in the field of Parkinson’s Disease. The aim of this study is to collect long-term data on tolerability and the change in Parkinson’s symptoms during treatment with Clarium, paying particular attention to quality of life and treatment satisfaction.
For the indication epilepsy, a NIS with our extended-release formulation Apydan extent (active substance: oxcarbazepine) has started at the beginning of 2010. Again, the primary aim is to generate long-term data on the safety and efficacy of the treatment after switching from other treatments or in patients being treated for the first time. By undertaking these research activities, we ensure that our products always reflect the latest scientific knowledge.
A summary of the main study parameters was published in the following study database: http://clinicaltrials.gov/ct2/home.
Note: Clarium and Apydan extent are not available in the UK.
DESITIN ARZNEIMITTEL GmbH was founded in Berlin in 1919. We developed and successfully introduced the still frequently used Desitin® ointment as our first product. In 1945, Desitin relocated to Hamburg, where the development and sales of medication for illnesses of the central nervous system (CNS) began. The company became a specialist supplier and competent partner […]Click to Expand
Desitin concentrates its marketing efforts on the European continent. In a number of countries (key countries mainly in the UK, Scandinavia and Eastern Europe as well as in Switzerland) Desitin is present with own sales forces, whereas in other countries licencees and partners distribute Desitin’s products.Click to Expand
Desitin is focused on pharmaceuticals for the treatment of epilepsy. It is the only manufacturer that offers the almost entire spectrum of products recommended by the WHO for the treatment of epilepsy. It should be noted that not all products are available in all countries. Desitin not only offers a wide range of different therapeutics, […]Click to Expand
Three active ingredients play a major role in Desitin‘s own developments for epilepsy: Valproic acid, which is the first-line therapy for generalized seizures, Carbamazepine, which is of the same relevance for focal seizures, and Oxcarbazepine the more modern alternative to Carbamazepine.Click to Expand
Medium-sized, specialized pharmaceutical company Founded nearly 100 years ago in Berlin Independent, family-owned, profitable company, based in Hamburg About 300 employees in development, production, sales, medicine, marketing and administration Established as a specialist in the field of epilepsy Addition of further CNS indications Fully integrated pharmaceutical company Incorporating sales & marketing, commercial, medical affairs and […]Click to Expand
Desitin’s straightforward approach together with the quality of its products from own development and licensors consequently lead to its high reputation within its main target group – neurologists – as shown in the results of the survey performed in Germany in 2013. Desitin is starting to build a reputation in the UK.Click to Expand
Desitin Pharmaceuticals GmbH – galenic innovation for over 40 years 2011 Levetiracetam Desitin The first levetiracetam minitablets worldwide (approved administration form: film-coated granules in sachets) 2010 Sumavel® DosePro® The first ready-to-use, needle free injector for sumatriptan in Europe* 2009 Topiramat Desitin quadro The first quartered topiramate tablet worldwide 2008 Apydan extent The first modified release formulation […]Click to Expand
Pharmaceuticals are developed, manufactured, procured, and tested at Desitin’s Hamburg site under modern conditions and then shipped to our customers worldwide. The comprehensive laws, regulations, and standards conforming to AMG, AMWHV, cGXP, etc. are mapped in a modern process-oriented and flexible organisation. Falsified Medicines Directive (Directive 2016/62/EU) Desitin is compliant with Directive 2016/62/EU. All products […]Click to Expand
Relevant information about our clinical development activities is provided below. At Desitin, we are proud of the fact that for decades we have consistently produced global innovations that have considerably improved and simplified drug treatment for doctors and patients, and have already become standard treatments. These innovations, which were and are always developed in close […]Click to Expand