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FDA Assessment FDA found insufficient evidence supporting intravenous emideltide for opioid withdrawal and no evidence supporting the nominated subcutaneous route

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Of the total adverse events reported, 37% were gastrointestinal in nature [207 events in 73 (77%) of 95 participants], most frequently nausea [67 events in 53 (56%) participants], vomiting [43 events in 23 (24%) participants], and dyspepsia [32 events in 27 (28%) participants]