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United States Food and Drug Administration (US FDA) has
granted approval to metoclopramide nasal spray for alleviating symptoms in
patients with acute and recurrent diabetic gastroparesis.
In adults with acute and recurrent diabetic gastroparesis, metoclopramide nasal spray a (dopamine-2 antagonist) has received US FDA approval for relieving symptoms. Regardless of gastric emptying delays and gastroparesis disease flares, this new formulation permits systemic absorption of metoclopramide. Due to delayed gastric emptying, gastroparesis patients often have erratic absorption of orally administered drugs.
Unlike other oral medications, metoclopramide is given nasally thus bypassing the diseased gastrointestinal tract. This may yield predictable delivery of the therapy since the drug directly enters the bloodstream. Its approval was substantially aided by established studies of oral metoclopramide for alleviating symptoms in acute and recurrent diabetic gastroparesis adults patients.
Compared to oral administration, the systemic absorption of metoclopramide after nasal administration is less (given the same dose) according to the pharmacokinetic data. After nasal administration of 15 mg metoclopramide, the systemic exposure to metoclopramide and the time to reach Cmax (highest concentration of a drug in the blood) were found to be comparable to orally administered 10 mg metoclopramide.
Due to greater risk of noxious reactions and elevated drug exposure, this product is not advocated in patients with moderate or severe kidney impairment (creatinine clearance <60 mL/min), patients concurrently utilizing strong CYP2D6 inhibitors, and patients with moderate or severe liver impairment (Child-Pugh B or C).
Due to high risk of developing tardive dyskinesia, other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates, it is also not suggested for utilization in pediatrics. Furthermore, this nasal spray is not advocated as initial therapy in elderly patients.
With regard to safety, metoclopramide nasal spray carries a boxed warning for tardive dyskinesia. In individuals with a history of tardive dyskinesia or a dystonic reaction to metoclopramide, it should be avoided.
In individuals with hazardous gastrointestinal motility, epilepsy, pheochromocytoma or other catecholamine-releasing paragangliomas, this nasal spray should be highly avoided. Headache, dysgeusia, and fatigue are the most common adverse reactions linked with treatment.
Metoclopramide nasal spray is supplied in a 10 mL bottle that delivers 15mg metoclopramide with each 70 microliter spray. Each amber glass bottle contains approximately 9.8 mL. This is adequate for four weeks of four times a day use. This nasal spray will be available commercially in the fourth quarter of 2020.
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