Developing safe and effective drugs to relieve chronic pain in kids
An EU-funded project that aims to improve the quality of life of children affected by chronic pain - who in most cases are treated with drugs that lack commercial authorisation - has just been launched. GAPP (GAbapentin in Paediatric Pain), which involves nine different countries from within and outside the EU, is the first international project to fully tackle this issue. Chronic pain is estimated to affect between 15 and 20% of children with varying disabilities. While the problem is widespread, it is poorly recognised and often undertreated. Normal pain killers have little or no effect on chronic neuropathic pain, a specific form of pain in which the nervous system is involved, which is why many traditional anticonvulsants have been used instead. Gabapentin for example has been used for the management of this type of pain -in both children and adults - for a number of years. While the mechanism for the analgesic effect of gabapentin remains unknown, a positive response has been demonstrated in a number of publications. To date however, most of the literature in this area has been case reports, with only a small number of clinical trials. The GAPP Project is therefore dedicated to exploring the paediatric application of drugs on children, and developing gabapentin for the treatment of paediatric chronic pain. The project will not only generate new clinical data; it will also work to make the new drug that is available for everybody. Through the development of appropriately controlled clinical trials, the project will investigate issues such as appropriate dosages, efficacy and safety. A non-clinical study for example will be conducted to evaluate the neurotoxic potential of the drug on very young children. "The first problem to be solved when a child has to take a medicine is that an appropriate dosage is administered," said Prof. Oscar Della Pasqua of the University College London, one of the project partners. "The drug might be otherwise ineffective or provoke adverse effects. In GAPP we will identify an optimal dosage for even the smallest children by applying models based on adult or older children dosages. This way we will be able to minimize the participation of the youngest children in the clinical trial." The kick-off meeting, which took place in November 2013, brought together all 15 partners in order to discuss the four years ahead. In particular, the meeting aimed to give all participants a better understanding of their tasks and goals, to illustrate the key elements of the clinical studies and to explore the regulatory aspects specific to each country involved. Intended joint actions and work packages of the project were fruitfully discussed in order to plan the future actions. Everyone involved in GAPP strongly believes that the project can make a huge difference to improving the quality of life of millions of kids. The initiative could also create valuable new market opportunities for Europe's pharmaceutical industry. This EUR 7.2 million project, which will be financed under the 7th Framework Programme for Research and Technological Development, will last 48 months. The EU is contributed EUR 5.5 million. It is being led by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), Italy.For more information, please visit: CVBF http://cvbf.net/ Project factsheet
Countries
Italy