Novel Intravenous ibuprofen formulation for the treatment of pain and fever in adults and children

急性疼痛是一个严重的问题，可在急性疾病或疾病过程、创伤或手术后发生。普罗维卡的目标是开发一种静脉注射(IV)配方的非专利药物，用于治疗成人和儿童的疼痛和发烧。他们将进行所需的临床研究，并申请针对英国和欧盟成人市场的许可证以及儿科用途营销授权(PUMA)。2010年，全球疼痛市场的销售额达到220亿美元，年复合增长率为8.9%。根据英国皇家外科学会的数据，英国国民健康保险制度进行了大约420万例外科手术。一项研究显示，80%的患者在手术后经历了急性疼痛。创新之处在于开发了一种新的获得许可的静脉注射配方，这将涉及进行所需的临床试验来评估药物疗效。需要进行药物动力学研究才能获得治疗疼痛和可能发烧的成人许可证。为了通过PUMA获得儿科执照，普罗维卡将需要进行疗效研究和一些药代动力学工作。该市场证明项目的主要目标是评估普罗维卡用于缓解成人和儿童疼痛和发烧的新静脉制剂的商业可行性，建立对英国和欧盟市场的全面验证，彻底了解患者、临床医生、全科医生、制药公司和其他利益相关者对新型静脉制剂的真实需求和要求。市场机会的早期绘制将大大加快项目的开发和实现，研究的欧洲范围将有助于普罗维卡了解更广泛的市场需求。

Acute pain is a significant problem and can occur following acute illness or disease processes,trauma or operative procedures. Proveca’s objective is to develop an intravenous (IV)formulation of an off-patent drug for the treatment of pain and fever in adults and children.They will undertake the required clinical studies and apply for a license to target the adultmarket in the UK and EU as well as for a Paediatric Use Marketing Authorisation (PUMA).The global pain market recorded sales of $22.0 billion in 2010, rising at a CAGR of 8.9%.About 4.2 million surgical procedures are carried out on the NHS in England according to theRoyal College of Surgeons. A study revealed that 80% of patients experienced acute painafter surgery. The innovation lies in developing a new licensed IV formulation, which willinvolve conducting the required clinical trials to assess the drug efficacy. Pharmacokineticstudies will be required to secure an adult license for pain and possibly fever. To obtain apaediatric licence through a PUMA, Proveca will need to conduct an efficacy study as well assome pharmacokinetic work. The key objective of this Proof of Market project is to assess thecommercial viability of Proveca’s new IV formulation for the relief of pain and fever withadults and children, to establish a full validation of the UK and EU market, gaining a thoroughunderstanding of the real needs and requirements of the patients, clinicians, GPs, pharmacompanies and other stakeholders for the novel IV formulation. The early mapping of themarket opportunities will significantly accelerate the development and realisation of theproject and the European scope of the research will help Proveca to understand the widermarket requirements.