When repurposing oral or parenteral therapies for inhaled administration, there are a number of important factors to evaluate early in the drug development process. Considering these factors may increase chances that a repurposed product could be positioned for successful clinical studies and commercial adoption by patients. A key question is, “Why are we repurposing the drug for inhalation?” The answer will guide foundational activities such as drug and target selection; preclinical activities; clinical studies; chemistry, manufacturing and controls (CMC)/quality and commercial positioning of the product.
Initial considerations in the development of “repurposed” drugs for inhalation
“Repurposing” of oral or parenteral products to the inhaled form is a promising way to develop products for treatment of many serious diseases, particularly where the lung is the natural site of action or optimal delivery location. Factors such as target product profile, product quality, pharmacology and clinical strategy should be taken into account to help provide a repurposed inhaled medication that may be a valuable option for patients.