Evoke Pharma has developed Gimoti (metoclopramide) nasal spray with promotility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis with diabetes mellitus. Since 1979, metoclopramide tablets and metoclopramide for injection have been the only products approved in the United States to treat gastroparesis. Gimoti is a novel formulation of metoclopramide providing systemic delivery via nasal administration.
Our nasal formulation of metoclopramide provides the target patient population with acute or recurrent symptoms of diabetic gastroparesis with a product that can be systemically delivered as an alternative to the oral and injection routes of administration. Nasal delivery is possible because the thickness of mucosa of the nasal cavity is a single epithelial cell layer which is well vascularized and allows metoclopramide molecules to be transferred directly to the systemic circulation without ingesting oral tablets. In addition, there is no first pass liver metabolism required prior to onset of action. Since gastroparesis is a disease that blocks or slows the movement of the contents of the stomach to the small intestine, oral drug administration is often compromised. Unlike the oral tablet formulation of metoclopramide, we believe that Gimoti may be tolerated even when patients are experiencing nausea and vomiting. The nasal formulation may also provide an alternative means of delivering metoclopramide in patients with delayed gastric emptying and/or frequent vomiting.
A nasal spray formulation of metoclopramide also has the potential to offer an alternative route of administration for patients receiving the parenteral formulation of metoclopramide. Following hospitalization for treatment with parenteral metoclopramide, a nasal spray formulation could also provide a non-oral option for patients transitioning to outpatient treatment.
On June 19, 2020, the U.S. Food and Drug Administration approved Gimoti. A copy of the FDA-approved Prescribing Information for Gimoti is available here.