The GAPP Project is funded by the European Commission under the Seventh Framework Programme (FP7) with the aim to improve the quality of life in children by expanding the range of medicines available to them.
In most cases children are treated with drugs for which only few information are available in terms of their effectiveness, safety and tolerability in paediatric patients.
While opioid analgesics such as tramadol and morphine represent the standard treatment for moderately severe to severe pain, these are not free of side effects and in many cases opioid rotation is required to maintain effective pain relief.
Beside the need of alternative opioids, the search of drugs effective in reducing neuropathic pain has been specifically listed by the 2012 WHO guidelines as a priority. Among these is gabapentin, which has been approved in several European Member States for the treatment of peripheral neuropathic pain but only in adults. In children, in lack of approved medications for this particularly debilitating condition, gabapentin is used off-label.
The GAPP Project thus intends to respond to this unmet therapeutic need. The proposed research plan, which has received the approval from the Paediatric Committee of the European Medicines Agency, is to conduct controlled randomised clinical trials using a gabapentin pediatric formulation both alone or in combination with morphine in order to confirm its efficacy and safety in paediatric patients affected by chronic pain with a neuropathic component.