Evoke Pharma Expands Patent Portfolio for GIMOTI Treatment

Evoke Pharma Strengthens Its Patent Protection for GIMOTI

Evoke Pharma, Inc. (NASDAQ: EVOK), a company renowned for its innovative approach to treating gastrointestinal (GI) diseases, recently made an exciting announcement. The company has received notices of allowance for two significant U.S. patent applications concerning GIMOTI® (metoclopramide) nasal spray. This advancement not only expands Evoke's intellectual property portfolio but also solidifies GIMOTI's unique position in the market as a leading treatment for gastroparesis.

The New Patent Applications

The two patents, identified as U.S. 17/366,839 and U.S. 17/366,818, focus on “Nasal Formulations of Metoclopramide.” They provide Evoke Pharma with additional claims that strengthen the protection of the intranasal administration of metoclopramide, specifically targeting the treatment of diabetic gastroparesis. Once granted, these patents will further enhance GIMOTI’s status as the only FDA-approved non-oral patient-administered therapy for managing acute and recurrent diabetic gastroparesis in the United States, with an anticipated expiration at the end of 2029.

Importance of Efficient Drug Absorption

A significant hurdle in managing gastroparesis is ensuring that medications are absorbed effectively. Patients often experience delayed stomach emptying, which complicates the impact of orally administered drugs. GIMOTI provides an innovative solution by bypassing the gastrointestinal tract, allowing for more reliable absorption and effective symptom relief for patients.

CEO Insights on GIMOTI's Future

Matt D’Onofrio, CEO of Evoke Pharma, expressed his enthusiasm regarding the new patents, emphasizing their importance in reinforcing GIMOTI’s role in the treatment landscape for gastroparesis. He noted, "GIMOTI is the only FDA-approved metoclopramide nasal spray, presenting a fresh alternative for diabetic gastroparesis patients who struggle with oral medication. Initial real-world data confirms that GIMOTI offers symptomatic relief, underscoring its significance in the marketplace. With no other competitive intranasal options currently under development and anticipated obstacles faced by alternative therapies, these patents amplify GIMOTI’s distinctive value and support our commitment to establishing a crucial market presence. Our mission is to set the benchmark for innovations in gastroparesis treatment."

Evoke Pharma's Mission and Method

Dedicated to advancing GI health, Evoke Pharma focuses on developing medications specifically aimed at treating various GI disorders. GIMOTI, a nasal spray formulation of metoclopramide, is designed to alleviate symptoms associated with acute and recurrent diabetic gastroparesis in adults, addressing a vital need in the market.

The Challenge of Diabetic Gastroparesis

Diabetic gastroparesis is a complex GI disorder impacting millions globally, characterized by prolonged gastric emptying that leads to severe gastrointestinal symptoms and systemic complications. Delays in gastric emptying can hinder the effectiveness of conventional oral medications. Previously, metoclopramide was solely available through oral and injectable forms, but with the FDA's approval of GIMOTI, a more efficient administration method is now accessible for patients.

Understanding GIMOTI

GIMOTI is indicated for the treatment of symptoms in adults encountering acute and recurrent diabetic gastroparesis. However, safety considerations are crucial for patients considering this option. A key warning associated with metoclopramide use is the potential development of tardive dyskinesia (TD), a severe movement disorder that is typically irreversible. Hence, it is advised to limit treatment duration to prevent complications related to TD development.

Patient Safety and Recommendations

Patients receiving GIMOTI should be aware of important safety information. Those with a history of tardive dyskinesia, gastrointestinal obstruction or perforation, severe hepatic impairment, and other specified conditions should avoid its use. Metoclopramide is not recommended for pediatric patients due to the heightened risk of TD and other effects. It is crucial for individuals to discuss potential side effects and evaluate the benefits with their healthcare providers before starting treatment.

Frequently Asked Questions

What is GIMOTI?

GIMOTI is a nasal spray formulation of metoclopramide, primarily used to relieve symptoms associated with acute and recurrent diabetic gastroparesis in adults.

How do the new patents affect GIMOTI?

The newly granted patents enhance GIMOTI’s protection against competition, solidifying its unique position as an FDA-approved treatment for gastroparesis.

What are the risks associated with GIMOTI?

Potential risks include tardive dyskinesia, other movement disorders, and common side effects like dysgeusia, headache, and fatigue.

Who should avoid using GIMOTI?

Patients with certain health conditions like hepatic impairment, epilepsy, and a history of tardive dyskinesia should avoid GIMOTI.

How does GIMOTI work for patients?

GIMOTI works by bypassing the GI tract through nasal administration, allowing for better absorption and symptom relief for patients with diabetic gastroparesis.

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