Opinion by Leana S. Wen: The opioid overdose antidote should have been made over-the-counter years ago.
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Hufford, an addiction researcher who then worked in the pharmaceutical industry to take products from prescription to OTC, called each company to offer consulting support. “The companies told me that they had no intention to do this,” he told me. That’s why he co-founded HRT as a nonprofit to manufacture naloxone. The other companies had already completed their clinical trials for the drug, but HRT had to start from scratch. It acquired and ran a clinical trial for a new intranasal formulation of naloxone. Then, it conducted a study to make sure consumers could use the product based on simple instructions. Finally, in October 2022, they finished submitting their application to the FDA.
And that’s not for lack of trying on the FDA’s part. As HRT conducted its trials, the agency continued to urge the other companies to apply for OTC status. It even took the unprecedented step of creating a
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