Tapping the potential of fixed-dose combinations

Developing a new molecular entity is a lengthy, expensive and high-risk endeavour. Reformulating drugs that have been proven to be safe and effective into fixed-dose combination (FDC) products represents an essential strategy for drug development companies to realize maximal commercial returns. Both patients and physicians could benefit from the potential increase in efficacy, convenience and compliance as well as fewer co-pays. Although it is necessary to address the unique risks and technical hurdles facing the development of an FDC1, an understanding of the commercial components is just as essential. Examples in three therapeutic areas — asthma, HIV and hyperlipidaemia — are given to illustrate the keys to FDC commercial success and the inherent risks.