Abstract
Real-world drug repurposingāthe immediate āoff-labelā prescribing of drugs to address urgent clinical needsāis a widely overlooked opportunity. Off-label prescribing (ie, for a nonapproved indication) is legal in most countries and tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, health crises may mean that real-world repurposing is the only realistic source for solutions. Optimal real-world repurposing requires a track record of safety, affordability, and access for drug candidates. Although thousands of such drugs are already available, there is no central repository of off-label uses to facilitate immediate identification and selection of potentially useful interventions during public health crises. Using the current coronavirus disease (COVID-19) pandemic as an example, we provide a glimpse of the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and targeted toward the underlying pathophysiology that makes COVID-19 so deadly. This paper briefly summarizes why cimetidine or famotidine, dipyridamole, fenofibrate or bezafibrate, and sildenafil citrate are worth considering for patients with COVID-19. Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our health care systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.
Highlights
COVID-19; drug costs; drug repositioning; drugs, generic; off-label use; public health; severe acute respiratory syndrome coronavirus 2; pandemic; crisis
The same month, in propitious timing, a few hundred of the worldās leading physicians, scientists, government agency officials, and nonprofit leaders gathered at an inaugural 2-day conference jointly sponsored by the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) in Washington, DC
The publicity generated by the US president endorsing the antimalarial agents hydroxychloroquine and chloroquine as treatments for COVID-19 jolted regulatory authorities worldwide
Summary
COVID-19; drug costs; drug repositioning; drugs, generic; off-label use; public health; severe acute respiratory syndrome coronavirus 2; pandemic; crisis. The topic of the conference was āRepurposing Off-Patent Drugs,ā and attendees had convened to discuss how widely used, low-cost, and safe medicines that are approved for one indication might be harnessed to provide additional, novel, and sometimes unexpected therapeutic benefits in other diseases.
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