Proveca Paediatric Ibuprofen IV (Powder for Reconstitution)

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With today’s major research and development activities of pharmaceutical companies focusedon meeting the needs of an increasingly aging population, children who represent the bulk ofthe dependent population worldwide still remain a widely neglected niche market. Therecognition of the rights of children to have access to safe and effective drugs and the needs ofhealthcare providers to receive age-appropriate drug information continues to have a majoreffect on all areas of paediatric pharmaceuticals.Proveca has been formed to develop and license essential medicines for children and makethem available in appropriate formats, to satisfy unmet priority health care needs of thepaediatric population (as defined on the EMA paediatric priority list).Proveca plans to develop an intravenous (IV) formulation of the off-patent drug ibuprofen (asa powder for reconstitution with water for injection), for the treatment of pain and fever inchildren. Acute pain is a significant problem and can occur following acute illness or diseaseprocesses, trauma or operative procedures. There are currently no licensed IV formulations ofibuprofen for the treatment of pain and fever in children in the EU. The introduction of thisnew product has the potential to improve the management of pain and fever in children byincreasing choice and decreasing the use of opiate drugs, which are associated with unwantedside-effects.The funding will enable Proveca to develop a formulation suitable for clinical trial use andready for scale up and manufacture. The new IV formulation, as a powder for reconstitution,will considerably reduce the risk of post-surgical complications, particularly related to opioidanalgesics, decrease the cost of medical care and accelerate recovery and a return to normalactivities of daily living.