Evoke Pharma Highlights GIMOTI as a Leading Solution for Gastroparesis Treatment as Domperidone Supply Ends

Evoke Pharma, Inc., a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI (metoclopramide) nasal spray, underscores its commitment to patients and healthcare providers managing gastroparesis in light of FDA’s recent update regarding domperidone supply. As the sole FDA-approved nasal spray treatment for acute and recurrent diabetic gastroparesis in adults, GIMOTI (metoclopramide) is uniquely positioned to address the ongoing needs of patients facing challenges with alternative therapies.

The FDA recently posted: “Efforts made in the interim to identify an alternative source [of domperidone] have been unsuccessful. The current supply will be exhausted as early as the first or second quarter of 2025, at which time this program will no longer be able to supply domperidone for treatment use under your expanded access IND. FDA understands that this may pose challenges as you continue to care for your patient(s). We are making you aware of this development now so that you may begin to explore other treatment strategies.” (https://www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use)

Domperidone, while used internationally for gastroparesis treatment and other GI conditions, has never been approved for use in the United States due to safety concerns, particularly its association with cardiac arrhythmias and sudden cardiac death. Despite this, some patients accessed domperidone under FDA’s expanded access program when other treatments proved insufficient. FDA’s recent announcement regarding the discontinuation of domperidone supply further highlights the urgent need for safe, effective, and accessible therapies like GIMOTI for patients struggling with gastroparesis.

Gastroparesis is a debilitating GI disorder wherein delayed stomach emptying, causes significant nausea, vomiting, early satiety, and abdominal pain often leading to dehydration, malnutrition and frequent ER visits and hospitalizations. These patients, particularly those who struggle eating a solid meal, often have issues taking oral medications either because they cannot easily take medicine (difficulty swallowing) may not keep medicines down (nausea and vomiting) or will not absorb medicine (due to delayed gastric emptying). Having effective treatments and routes of administration that can deliver medicine reliably are increasingly important.

Patient Advocate, Melissa VanHouten, stressed “This news will have a negative impact on the gastroparesis community, so it is critically important to communicate this change to patients and their providers. People with gastroparesis had very few options prior to this news and the fact that there is only one FDA approved compound remaining for my community is unacceptable. That said, it is important for patients and providers to re-educate themselves about the options that are available, like oral metoclopramide and GIMOTI, and for all stakeholders to reduce the barriers to access to these and other medications that will improve their quality of life.”

Matt D’Onofrio, CEO of Evoke Pharma, added “FDA’s recent announcements highlight the critical need for reliable treatment options for patients. We believe GIMOTI addresses many needs of patients with gastroparesis and diabetes through its unique nasal spray delivery. It remains the only non-oral therapy that bypasses the GI tract, addressing the core defect of delayed emptying, and provides a practical and proven solution to relieve symptoms”

Evoke Pharma remains committed to driving innovation and delivering value to patients, providers, and payors with strong supportive evidence. Real-world data has demonstrated significant clinical benefits of GIMOTI, including a 60% reduction in emergency room visits and a 68% decrease in hospitalizations compared to oral metoclopramide. Importantly, 61% of the patients on GIMOTI were previously on oral metoclopramide, suggesting that patients who previously did not receive an optimal benefit on oral might significantly benefit by switching to GIMOTI. Additionally, GIMOTI has shown a substantial reduction in overall healthcare costs, underscoring its potential to improve outcomes while reducing the burden on the healthcare system.

Mr. D’Onofrio said “We are proud to support patients and providers with GIMOTI, a treatment that combines innovation with proven efficacy. As alternative treatment options like domperidone become unavailable or harder to access, GIMOTI’s unique value proposition becomes even clearer, providing reliable symptom relief and improving quality of life for gastroparesis patients without a major burden on healthcare resources, patients, or payors.”

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. For more information, visit www.EvokePharma.com .