RÉSUMÉ
Traditionally, the main model of the pharmaceutical industry for developing new drugs has been based on monotherapies, new molecular entities (NMEs), and their underlying one-target-one-disease dogma. It is no surprise that closely related fields such as the cosmeceutical and nutraceutical areas, largely inspired by Big Pharma, have also mainly used that model. However, compelling evidence suggests that the time has come for these sectors of R&D activities to further explore more efficient, cost-effective and reliable approaches for innovative products. Among a few approaches proposed in recent years, there is one that is of particular interest – the ‘combination drug’ often referred to as the fixed-dose combination (FDC) products approach. It has been generally defined as two or more active ingredients that are combined in a single dosage form for either new effects or superior synergistic-like efficacy with less adverse effects. Both the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) have recognized the great potential of FDCs for the future of innovation in those sectors. In fact, the development of FDCs has recently received substantial support for commercialization of new products – that is between three and five years of additional protection and exclusivity. Next-generation FDCs have already been identified. Indeed, FDCs that may be referred to as ‘variable-dose combinations’ (VDCs) products and, more specifically, ‘Co-Activation of Natural Synergistically-Acting Target-Receptors’ (CanSATs) products when applied to natural products if synergistic-like actions are found among active ingredients. Although VDCs and CanSATs have emerged mainly from the nutraceutical and cosmeceutical sectors, these approaches may perhaps also promote the development of promising new pharmaceutical products.