As Applicant, PHARM obtained approval for a Paediatric Investigation Plan for the development of gabapentin in the treatment of paediatric chronic pain. This approval allowed PHARM to be the driver for the constitution of a large international consortium which was the proponent of GAPP (GAbapentin in Paediatric Pain) within the 7th call of the FP7 (THEME HEALTH.2013.4.2-1: Investigator-driven clinical trials for off-patent medicines using innovative, age-appropriate formulations and/or delivery systems), a project based on the same development plan approved by EMA-PDCO.
The GAPP Project aims at improving the quality of life (QoL) in children affected by chronic pain. These patients are treated in most cases with drugs which are not authorised for paediatric use. Participants will conduct controlled clinical trials investigating dosage, efficacy and safety of gabapentin for the treatment of paediatric pain.
About the GAPP (GAbapentin in Paediatric Pain) Project:
GAPP (GAbapentin in Paediatric Pain), is the first European project, funded by the EU-FP7, with the aim to improve the QoL in children affected by chronic pain, a widespread but poorly recognised condition, that affects 15-20% of children with varying disabilities and that is treated, in most cases, with drugs that are not authorised for paediatric use or used as ‘off-label’. Due to the paucity of clinical information and appropriate medicinal products, in clinical practice, paediatric patients are often under-treated causing profound impact on their QoL. To date, opioids, non-steroid anti-inflammatory drugs (NSAIDs), antidepressants and anticonvulsants are used to treat pain, but only few of these include a paediatric authorisation.
In addition, the few available paediatric drugs have a very different authorisation profile across Europe and, when not approved in paediatrics, they are used off-label to cover the high therapeutic need, thus exposing children to unnecessary risks of dosing errors and increasing ADRs.
In order to fulfil this gap, the GAPP project aims to study and make available on the market a drug (Gabapentin), by developing controlled clinical trials to investigate the paediatric dosages and the efficacy and safety profile of Gabapentin in the treatment of paediatric chronic pain.
This goal is made possible thanks to a multidisciplinary approach, based on the collaboration between pharmacists, clinical neurologists and paediatricians from 9 European and non-European Countries, which resulted in the creation of a large international scientific Consortium with experienced professionals in the field of pain.
Within GAPP, age-appropriate formulation will be developed and two randomised, comparator-controlled clinical trials (GABA-1 e GABA-2), and a bridging study will be conducted in compliance to a submitted Paediatric Investigation Plan (PIP, Summary Report Day 90 – EMEA-001310-PIP01-12) in order to investigate appropriate dosages, efficacy and safety of gabapentin in the paediatric population. Further to this, in order to ensure the safety of gabapentin in very young children, a non-clinical study will be conducted to evaluate the neurotoxic potential of the drug. At the end of the project, gabapentin can be proposed for treatment of chronic pain in children both as monotherapy and as adjuvant therapy.
The GAPP Kick-off Meeting press release entitled “EU FP7 GAPP – GAbapentin in Paediatric Pain Project Kick-off. Toward new therapies to challenge chronic pain in children”, was published on the CORDIS (Community Research and Development Information Services) website.