Evoke Pharma reaffirms its commitment to gastroparesis patients amid industry developments Page 1

Gimoti remains the only FDA-approved treatment for symptoms of diabetic gastroparesis

SOLANA BEACH, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company primarily focused on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti (metoclopramide) nasal spray, reaffirms its commitment to improving the lives of patients with diabetic gastroparesis in light of the U.S. Food and Drug Administration’s (FDA) recent decision not to approve Vanda Pharmaceuticals’ New Drug Application (NDA) for Tradipitant, an oral drug candidate for the treatment of symptoms in gastroparesis. Patients with all forms of gastroparesis require additional tools to treat this challenging disease, and we believe patients will be disappointed given the FDA’s decision. Evoke continues to be a trusted partner for healthcare professionals and patients alike with its proven product, Gimoti (metoclopramide), the first and only FDA-approved nasal spray treatment for acute and recurrent diabetic gastroparesis in adults.

“While challenges in the regulatory landscape impact all of us in the industry, Evoke remains focused on improving patient outcomes and expanding access to GIMOTI, the only non-oral outpatient treatment for acute and recurrent symptoms of diabetic gastroparesis, which has already demonstrated significant benefits in real-world settings,” said Matt D’Onofrio, CEO of Evoke Pharma. “We have been able to provide Gimoti to over 4,000 patients since launch and continue to strive to educate patients and physicians about the benefits of non-oral treatments for this disease.”

Diabetic gastroparesis is a serious condition and remains complex to treat effectively with only one FDA approved active molecule (metoclopramide) available. Gimoti, the nasal formulation of metoclopramide, was developed by Evoke Pharma specifically as an oral treatment due to the complexity of gastroparesis. Oral treatments are prone to poor absorption due to delayed gastric emptying blocking delivery or symptoms causing vomiting of pills, further complicating oral drug therapy.

People with diabetic gastroparesis, who often take multiple oral medications, know first-hand the challenges of taking and digesting pills or tablets with this disease. To confirm the impact of GIMOTI and the nasal route of administration, Evoke has provided the first-ever comparative data in the field of gastroparesis, showing a statistically significant improvement in patient outcomes between Gimoti and oral metoclopramide. This real-world data, presented at Digestive Disease Week 2023, showed that patients with diabetic gastroparesis taking Gimoti experienced significant reductions in emergency room visits (-60%, p=0.007) and hospitalizations (-68%, p=0.005) compared to oral metoclopramide over a six-month period. In addition, 61.5% of patients in this study treated with Gimoti had previously taken oral metoclopramide, suggesting that some patients who did not experience symptom relief with oral metoclopramide did achieve relief with a new treatment of GIMOTI. A separate cost analysis found that GIMOTI reduced total healthcare costs by approximately $15,000 in the first six months after initiation of treatment, compared with oral metoclopramide.