Topical Fixed-Dose Combinations: A Way of Progress for Pain Management?

Pain, a severe public health problem, can affect patient quality of life when inadequately controlled. Consid-ering that pain pathophysiological mechanisms are complex, combining active pharmaceutical ingredients (APIs) with multiple and synergistic mechanisms of action represents a potentially more effective therapeutic approach than conventional monotherapy treatments. In turn, topical drug delivery has clear advantages over other routes of administration, such as high levels of efficacy, better safety profile and great patient compliance. In this context, the combination of two or more APIs ina single dosage form -fixed-dose combi -nation product (FDC) -for topical administration may represent a promising therapeutic option in the field of pain management. Considering the above mentioned, the purpose of this manuscript is to address an over-view of some general aspects regarding pain management and FDCs, as well as the regulatory environment that has to be taken into consideration during their development. Special emphasis will be given to fixed-dose combinations for topical administration with analgesic and/or anti-inflammatory activity. Market driv-ers of the topical FDC currently approved are ultimately pointed out, and new opportunities in pain manage-ment highlighted. (c) 2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.