Proveca Paediatric Ibuprofen IV (Powder for Reconstitution)

随着今天制药公司的主要研究和开发活动集中于满足日益老龄化的人口的需求，儿童仍然是一个被广泛忽视的利基市场，他们占全球依赖人口的大部分。认识到儿童有权获得安全有效的药物，以及保健提供者需要获得适合年龄的药物信息，这一认识继续对儿科药物的所有领域产生重大影响。已经成立了普罗维卡，以开发和许可儿童基本药物，并以适当的形式提供这些药物，以满足儿科人口未得到满足的优先卫生保健需求(如EMA儿科优先清单所定义)。普罗维卡计划开发一种非专利药物布洛芬的静脉(IV)配方，用于治疗儿童疼痛和发烧。急性疼痛是一个严重的问题，可在急性疾病或疾病、创伤或手术后发生。目前，欧盟没有获得许可的布洛芬静脉制剂用于治疗儿童疼痛和发烧。这种新产品的推出有可能通过增加选择和减少阿片类药物的使用来改善儿童疼痛和发烧的管理，阿片类药物与意外的副作用有关。这笔资金将使Provea能够开发一种适合临床试验使用的配方，并准备好扩大规模和生产。新的静脉注射制剂作为重建的粉末，将大大减少手术后并发症的风险，特别是与阿片类镇痛剂有关的并发症，降低医疗费用，加速康复和恢复正常的日常生活活动。

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.