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OxARO is a fixed-dose combination small molecule drug being developed by SafeRx Pharmaceuticals to address moderate-to-severe pain and opioid use disorder while mitigating the risks of concurrent alcohol consumption. It combines oxycodone hydrochloride, a mu-opioid receptor (MOR) agonist, with disulfiram, an aldehyde dehydrogenase (ALDH) inhibitor. This combination is part of the Alcohol-Resistant Opioid (ARO) platform, designed to trigger an unpleasant physiological reaction if alcohol is consumed, thereby deterring the dangerous co-ingestion of opioids and alcohol. SafeRx Pharmaceuticals is pursuing FDA approval through the accelerated 505(b)(2) regulatory pathway, leveraging existing safety and efficacy data for the individual components.
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