The American story of apomorphine: between mistrust and remarkable discoveries (P4-3.006)

Abstract

<h3>Objective:</h3> To review the history of apomorphine in the United States of America (USA) and the stigma surrounding it, taking into account both its medical and non-medical uses <h3>Background:</h3> Despite extensive and worldwide evidence of clinical efficacy and safety in the management of Parkinson’s disease (PD), and despite being approved by the Food and Drug Administration (FDA) as both an injection (2004) and a sublingual film (2020), apomorphine is currently not available in the USA as a continuous subcutaneous administration infusion (CSAI). In October 2022, the FDA issued a Complete Response Letter for the new application as a drug infusion device. <h3>Design/Methods:</h3> Nonsystematic database (MEDLINE, NCBI, PubMed, Google Scholar, JSTOR, Internet Archive) search and screening of online American newspapers archives (Newspapers.com®) with the search terms <i>apomorphine</i> and <i>apomorphia</i> (1845–2022) <h3>Results:</h3> Following its European synthesis in the mid-19th century, apomorphine was successfully and extensively used by American clinicians from the 1870’s onwards, in the management of both pediatric and adult patients. However, its unsubstantiated inclusion in the Harrison Narcotic Tax Law put a major stop in its clinical use. Despite these limitations, the USA was the first country to conduct clinical trials using apomorphine for PD in 1951. Apomorphine non-medical use, including abusive practices (vomiting punishment) in boarding schools and hospitals (1900’s), truth serum (1920’s), tranquiliser gun or race horse drugging (1970’s) have surely contributed to damage its reputation. <h3>Conclusions:</h3> It is difficult to explain the residual stigma surrounding apomorphine in the US without considering the intertwining of the medical &amp; non-medical worlds, the long-lasting effects of “fashion” or reputation, as well as the political and economic context. <b>Disclosure:</b> Dr. Auffret has received personal compensation for serving as an employee of France Développement Electronique. The institution of Dr. Auffret has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Britannia. Dr. Auffret has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Britannia. Dr. Auffret has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Britannia. Dr. Auffret has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aguettant. The institution of Dr. Auffret has received research support from Association France Parkinson. The institution of Dr. Auffret has received research support from Homeperf. The institution of Dr. Auffret has received research support from LVL. The institution of Dr. Auffret has received research support from University of Rennes 1. The institution of Dr. Auffret has received research support from Aguettant. The institution of Dr. Auffret has received research support from Linde. The institution of Dr. Auffret has received research support from Plateforme Nationale pour la recherche sur la fin de vie. Dr. Auffret has received publishing royalties from a publication relating to health care. Dr. Lees has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Britannia. Dr. Lees has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with Bial Pharma. Mr. Verin has nothing to disclose.