Donato BonifaziEuropean Projects Forum

“Nextwork”, May 16th, 2015, Bucharest

What is GAPP?

GAPP (Gabapentin in Paediatric Pain) is a four-year European research Project (FP7) coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) with the aim to improve the quality of life of children affected by chronic pain, treated in most cases with drugs that are not authorised for paediatric use.

In order to fulfil this gap, GAPP aims to study and make available on the market a drug (Gapapentin), 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.

Who are we?An international scientific Consortium of 15 Partners from public and private

research institutions coming from 9 European and non-European Countries (Albania, Estonia, France, Germany, Greece, Italy, Spain, The Netherlands, United Kingdom) with experienced professionals in the field of pain.

ScopeThe scope of the GAPP project is to expand the availability of medicines for

children affected by chronic pain of neuropathic origin (a condition for which the paediatric therapeutic need is very high and well recognized), thus enhancing their quality of life.

The drug to be developed is gabapentin, a drug already used for the treatment of neuropathic pain in adults.

• Antiepileptic/anticonvulsant drug that acts on chemicals and nerves in the body involved in seizures and some types of pain

• Approved for both epilepsy (seizures) and neuropathic pain in adults

• Approved for epilepsy, with frequent off-label use for neuropathic pain, in children

What is gabapentin?

What is neuropathic pain?

• Caused by problems with signals from the nerves

• Often described as shooting, aching, or like electric shock

• Underlying causes include cancer/chemotherapy, amputation (leading to phantom limb pain), trauma, surgery, and nerve disorders such as complex regional pain syndrome

• Not responsive to traditional painkillers (parecetemol, morphine, codeine)

• Often treated with antidepresants and antiepileptics/anticonvulsants

• Can occur alone or together with nociceptive pain, which is caused directly from tissue damage such as cuts, burns, or tumors and responds well to traditional painkillers

GAPP focuses on chronic neuropathic pain, which is pain that has been ongoing or recurrent over at least three months

Why testing gabapentin in children?

• Due to its efficacy in the treatment of chronic neuropathic pain of different aetiology, gabapentin is largely used off-label in the treatment oncological pain, trigeminal neuralgia, complex regional pain syndromes, headaches, pain following spinal cord injury, pain associated with multiple sclerosis, phantom limb pain and treatment of herpes zoster

• Notwithstanding the efficacy that gabapentin has shown in a wide variety of pain syndromes, thoughtfully designed, large scale clinical trial should be performed to confirm its efficacy and safety in children.

• Gabapentin appears to be also an important therapeutic tool in the reduction of chronic mixed pain in children for which morphine is often used as standard therapy.

Thus, as in adult, gabapentin could represent not only a valuable alternative to morphine but also a mean to reduce morphine requirement and addiction risk.

Objectives• To develop a new oral liquid formulation of gabapentin suitable for use

in children;

• To perform 2 controlled efficacy and safety clinical trials in children from 3 months of age to less than 18 years old, with moderate and severe pain respectively (called GABA1 and GABA2);

• To perform a bridging study to specifically address the paucity of data available from children ranging from 3 months to 3 years old. This study will integrate data collected in the clinical studies proposed above (GABA-3);

• To perform a toxicity study (preGABA) for the investigation of the potential effects of gabapentin on the central nervous system development.

Expected Outcomes

With the support of the European Commission, the project partners will work together to demonstrate that the new paediatric gabapentin formulation is safe and effective in treating chronic pain with a neurophaticcomponent when used alone or, in the most sever forms, in combination with morphine.

The results of the project will be used to make a properly tested medicine available to children to threat their pain.

GAPP Website

.pediatricpain.eu

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ContactPROJECT COORDINATOR

Consorzio per Valutazioni Biologiche e Farmacologiche

Via Luigi Porta 14, 27100 PAVIATel. +39 0382 25 075

Corso Alcide De Gasperi 435, 70125 BARITel. +39 080 86 41 260

E-mail: info@pediatricpain.eu

This presentation reflects only the author’s views and the European Union is not liable for any use that may be made

with the information contained therein.

This material cannot be distributed nor re-utilised without acquiring a specific preliminary Author’s written consent.