Representatives of the project leader, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF, Bari, Italy) and project partners from 9 different European and non‐European countries gathered in the kick-off meeting to set the general organisation and communication basis of what is considered to be a scientific challenge within pharmacological research: finding a new drug and its appropriate dosage to improve the lives of children under 18 suffering from chronic pain.

In particular, GAPP aims to study gapapentin, a drug for which a great therapeutic interest has already been demonstrated, and make it available on the market in order to improve the quality of life in children with chronic pain, a widespread but poorly recognised problem that is in most cases treated with drugs which are not approved or used off-label.

Not only requiring high expectations from professionally dedicated clinical trials but also from a social and communication area, as the population to whom it is addressed, it’s a sensitive and vulnerable research subject; the project is seen, according to all involved parties’ statements, as a hopeful, revolutionary endeavor aiming to relieve young patients of one of health dire issues: chronic pain.

Through the development of two appropriately controlled clinical trials (GABA-1 e GABA-2), sponsored by Pharmaceutical Research Management Srl (PHARM), as decided during the General Assembly in June 2014, the project will investigate appropriate dosages, efficacy and safety of this drug in the treatment of paediatric pain. If the results of the studies lead to positive results, gabapentin will be able to respond to an unmet therapeutic need. PHARM is also the Applicant of the PIP (EMEA-001310-PIP01-12) submitted to the PDCO for the development of gabapentin in paediatric chronic pain with neuropathic component and will coordinate the clinical operations for the conduction of the two clinical trials. The new formulation of gabapentin for paediatric use will be developed, produced and distributed to participating clinical centres by Dompé SpA, one of the main biopharmaceutical industries in Italy, that will also coordinate the nonclinical development of the juvenile toxicity study.

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 CORDIS – Community Research and Development Information Services (for a list of press releases please visit the dedicated Press Releases section of this website).

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