Intranasal metoclopramide for acute and recurrent diabetic gastroparesis in adults

Metoclopramide is a prokinetic agent used to promote gastrointestinal motility. It is available for intramuscular, intravenous, subcutaneous and oral administration. In June 2020, metoclopramide nasal spray (MNS) 15 mg (administered 30 min before each meal and at bedtime for 2–8 weeks), received FDA-approval for the acute and chronic management of diabetic gastroparesis (DG) in adults. Four studies that evaluated the efficacy and tolerability of MNS in patients with DG were identified, but none evaluated MNS 15 mg. Of the four studies, one found MNS more effective than metoclopramide tablets: per-protocol patients receiving MNS 10 mg and 20 mg experienced a statistically significant reduction in total symptom scores at six weeks, versus metoclopramide 10 mg tablets. In three placebo-controlled 4-week studies, DG symptom improvements seen with MNS 10 mg or 14 mg were statistically insignificant in men but were statistically significant in women. Adverse events of mild-to-moderate severity included headache, cough, nasal discomfort and dysgeusia. Further research is needed to assess the efficacy (e.g., individual and combined symptom scores, hospitalizations due to acute flares), tolerability, pharmacokinetics and cost-effectiveness of MNS 15 mg over 8–12 weeks in patients with DG.