Overdose reversal drug to be sold over-the-counter following recent FDA approval
Recently, the Food and Drug Administration (FDA) approved NARCAN® to be sold over the counter. NARCAN® is used to prevent opioid overdose deaths.
Nancy Campbell, Rensselaer Polytechnic Institute professor and graduate program director in Science and Technology Studies, comments on the significance of this development below. Campbell’s research focuses on science, technology, and medicine as it relates to drugs, drug policy, and the social significance of legal and illegal drugs, with a recent focus on opioid overdose. She studies those who govern and use drugs, produce scientific knowledge about them, and seek to treat drug problems.
In March 2023, the FDA approved NARCAN® (naloxone nasal spray made by Emergent BioSolutions Inc.) to be sold over-the-counter (OTC). Why would a drug synthesized in 1960, approved by the FDA for opioid overdose reversal in 1971, and still used every day in operating rooms and emergency medicine become the center of a projected billion dollar consumer market by 2027?
For the past 40 years, there has been an exponential rise in U.S. opioid overdose deaths of 9% every year. We are still on that trajectory. Twenty years into this ongoing increase in overdose deaths, the naloxone activists, researchers, and advocates who are the protagonists of OD: Naloxone and the Politics of Overdose (MIT 2020) by Rensselaer historian Nancy D. Campbell, noticed their friends dying and decided to do something about it. They created overdose prevention education and struggled to liberate naloxone and get it into the hands of those who need it most. In the late 1990s, a harm reduction social movement formed to liberate naloxone from the exclusive control of medicine and distribute it through community-based programs that saw naloxone as a public good.
Harm reduction advocates worked with local sheriffs’ departments and other first responders to get them to start carrying naloxone. They got the CDC to start tracking ODs. They worked to get state legislatures to change naloxone access laws and Good Samaritan laws to allow bystanders to intervene. To prevent opioid overdose deaths, they got friends and family involved in harm reduction efforts. Public Health Departments got onboard in areas where public funds are spent on harm reduction and overdose prevention.
Naloxone started its career as an injectable solution. EMTs innovated an intranasal method in the early 2000s and a nasal spray product was FDA-approved in 2015. Two years later, FDA took the unusual step of calling on pharmaceutical companies for proposals for OTC naloxone and conducting some of the necessary studies at FDA expense. This process led to the March 2023 approval of nasal spray NARCAN®. What will be the fate of street distribution in the public interest when OTC naloxone appears on drugstore shelves? We haven’t heard what its shelf price will be. Will those who need it most be able to afford it? Will the broader public become more educated about overdose prevention?
Naloxone is not enough to reverse the opioid overdose death curve. I am hoping that OTC naloxone — in conjunction with other public health overdose prevention measures — is enough to crest the wave. But it will take all of us together to address 40 years of social, political, and economic forces that have driven opioid overdose death rates to socially unacceptable levels.
Campbell is available to speak with media - simply click on her icon now to arrange an interview today.
Nancy D. Campbell Professor and Graduate Program Director, Science and Technology Studies (STS)
Focuses on the history of science, technology, and medicine as it relates to drug policy and the social significance of drugs