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About Evoke Pharma Inc.
Evoke Pharma Inc. (NASDAQ: EVOK), headquartered in Solana Beach, California, is a specialty pharmaceutical company dedicated to the development and commercialization of innovative treatments for gastrointestinal (GI) disorders and diseases. With a primary focus on diabetic gastroparesis, Evoke addresses a critical unmet medical need by offering a novel, non-oral treatment option that improves patient outcomes and enhances quality of life.
Core Product: Gimoti
At the heart of Evoke Pharma's portfolio is Gimoti®, an FDA-approved nasal spray formulation of metoclopramide. Designed specifically for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults, Gimoti offers a unique solution for patients who struggle with oral medications due to delayed gastric emptying, a hallmark of gastroparesis. By bypassing the gastrointestinal tract, Gimoti ensures reliable drug absorption, addressing the core defect of the disease and providing a practical alternative to traditional oral and injectable formulations.
Market Position and Competitive Landscape
Diabetic gastroparesis is a debilitating condition affecting millions worldwide, with a disproportionate prevalence among women. Despite its widespread impact, treatment options remain limited. Metoclopramide is the only FDA-approved drug for gastroparesis in the United States, and Gimoti stands out as the sole non-oral formulation available. This positions Evoke Pharma as a key player in the GI treatment landscape, offering a differentiated product that meets the needs of a historically underserved patient population.
Innovative Approach and Strategic Partnerships
Evoke Pharma's commitment to innovation is evident in its development of Gimoti, which leverages intranasal drug delivery to overcome the challenges associated with oral medications in gastroparesis patients. The company has also established strategic partnerships, such as its collaboration with EVERSANA, to support the commercialization and market access of Gimoti. These partnerships enhance Evoke's ability to reach patients, streamline the prescription process, and ensure broad access to its groundbreaking therapy.
Real-World Evidence and Impact
Real-world data underscores the clinical and economic benefits of Gimoti. Studies have demonstrated significant reductions in emergency room visits and hospitalizations among patients treated with Gimoti compared to oral metoclopramide. Additionally, Gimoti has shown a substantial reduction in overall healthcare costs, highlighting its value to both patients and payers. These outcomes reinforce Evoke Pharma's role in improving patient care and reducing the burden on the healthcare system.
Commitment to Patients and Providers
Evoke Pharma is dedicated to addressing the challenges faced by gastroparesis patients and their healthcare providers. The company's patient assistance programs and efforts to expand pharmacy distribution networks reflect its mission to ensure that no patient goes untreated due to economic or access barriers. By prioritizing patient-centric solutions and leveraging strong clinical evidence, Evoke continues to set the standard for innovation in gastroparesis treatment.
Evoke Pharma (NASDAQ: EVOK), a specialty pharmaceutical company focusing on gastrointestinal (GI) treatments, has announced the issuance of US patent No. 11,628,150 for its GIMOTI® (metoclopramide) nasal spray. This patent, expiring in 2029, covers specific formulations of metoclopramide. The company intends to list this patent in the FDA Orange Book shortly, enhancing its patent portfolio alongside existing patents in the EU, Japan, Canada, and Mexico. CEO Matt D'Onofrio emphasized the importance of this patent in protecting GIMOTI's proprietary administration route, vital for commercial success. GIMOTI addresses symptoms of diabetic gastroparesis, a serious GI disorder affecting many patients globally. This approval reinforces Evoke's commitment to innovation in the GI space.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced that the USPTO has issued a Notice of Allowance for U.S. Application No. 17/100,664 concerning GIMOTI, its nasal spray formulation of metoclopramide. The patent, entitled "Nasal Formulation of Metoclopramide," will be issued on April 18, 2023, and is set to expire in 2030. GIMOTI is the first FDA-approved nasal formulation of metoclopramide, specifically for adults suffering from acute and recurrent diabetic gastroparesis. This new patent strengthens Evoke's existing patent portfolio and reflects the innovation of GIMOTI in improving treatment outcomes for patients, as stated by President & COO Matt D’Onofrio.
Evoke Pharma (NASDAQ: EVOK) has presented real-world data at the AMCP Annual Meeting that highlights the benefits of GIMOTI (metoclopramide nasal spray) in reducing healthcare resource utilization (HCRU) among patients with diabetic gastroparesis (DGP). The study involved 294 patients and demonstrated a significant decrease in physician office visits from an average of 2.2 pre-treatment to 2.0 post-treatment (p=0.03). Additionally, outpatient visits decreased from 1.6 to 1.0 (p<0.01). This finding underscores the potential of GIMOTI to improve patient outcomes and reduce healthcare costs, solidifying its position as an innovative treatment option.