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

用于治疗成人和儿童疼痛和发烧的新型静脉注射布洛芬制剂

• 批准号: 700087
• 金额: $ 3.1万
• 依托单位: PROVECA
• 依托单位国家: 英国
• 项目类别: GRD Proof of Market
• 财政年份: 2012
• 资助国家: 英国
• 起止时间: 2012 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=700087
• 关键词: Novel; Intravenous; ibuprofen; formulation; treatment

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.

急性疼痛是一个重要的问题，可能发生在急性疾病或疾病过程、创伤或手术过程之后。Proveca的目标是开发一种用于治疗成人和儿童疼痛和发热的非专利药物的静脉注射（IV）制剂。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使用营销许可证。2010年全球疼痛市场的销售额为220亿美元，以8.9%的复合年增长率上升。根据英国皇家外科学院的数据，英国国民保健服务系统进行了大约420万例外科手术。一项研究表明，80%的病人在手术后经历过急性疼痛。创新在于开发一种新的许可IV制剂，该制剂将涉及进行所需的临床试验以评估药物疗效。需要进行药代动力学研究，以确保获得疼痛和可能的发热的成人许可证。为了通过CNOAA获得儿科许可证，Proveca将需要进行疗效研究以及一些药代动力学工作。该市场证明项目的主要目标是评估Proveca用于缓解成人和儿童疼痛和发热的新型IV制剂的商业可行性，以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IV制剂的真实的需求和要求。市场机会的早期映射将大大加快项目的开发和实现，欧洲范围的研究将有助于Proveca了解更广泛的市场需求。