FDA Approves Gimoti Nasal Spray for Diabetic Gastroparesis

The Food and Drug Administration (FDA) has approved Gimoti™ (metoclopramide; Evoke Pharma) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Gimoti, a dopamine-2 (D₂) antagonist, is a nasal spray formulation of metoclopramide. The novel formulation allows for systemic absorption of metoclopramide regardless of gastric emptying delays and gastroparesis disease flares. 

“[Gastroparesis] patients often have erratic absorption of orally administered drugs due to delayed gastric emptying,” said Henry Parkman, MD, Stanley H. Lorber Research Endowment Fund and Chair, and Director, Gastroenterology Motility Laboratory, School of Medicine at Temple University. “Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI tract, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy.”

The approval was supported by established studies of oral metoclopramide for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. According to pharmacokinetic data, the systemic absorption of metoclopramide after nasal administration is lower than that after oral administration given the same dose. Following nasal administration of Gimoti 15mg, the systemic exposure to metoclopramide and the time to reach C_max were similar to orally administered metoclopramide 10mg.

The product is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (CrCl <60 mL/min), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. It is also not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. Additionally, Gimoti is not recommended as initial therapy in elderly patients.

With regard to safety, Gimoti carries a Boxed Warning for tardive dyskinesia and is contraindicated in patients with a history of tardive dyskinesia or a dystonic reaction to metoclopramide. Moreover, the drug is contraindicated for use when stimulation of gastrointestinal motility might be dangerous, in patients with pheochromocytoma or other catecholamine-releasing paragangliomas, and in those with epilepsy. The most common adverse reactions associated with treatment include dysgeusia, headache, and fatigue. 

The product is supplied in a 10mL amber glass bottle delivering 15mg of metoclopramide with each 70 microliter spray. Each bottle contains 9.8mL which is sufficient for 4 weeks of 4 times a day use. The Company anticipates having Gimoti available in the fourth quarter of 2020.

For more information visit evokepharma.com.