Evoke Pharma Reaffirms Its Commitment to Patients with Gastroparesis Amid Industry Developments
Rhea-AI Summary
Evoke Pharma reaffirms its commitment to patients with diabetic gastroparesis following the FDA's decision not to approve Vanda Pharmaceuticals' Tradipitant. Evoke's product, Gimoti (metoclopramide nasal spray), remains the sole FDA-approved non-oral outpatient treatment for acute and recurrent symptoms of diabetic gastroparesis in adults.
Real-world data presented at Digestive Disease Week 2023 showed that Gimoti users experienced significant reductions in emergency room visits (-60%) and hospitalizations (-68%) compared to oral metoclopramide over six months. A cost analysis revealed that Gimoti reduced total care costs by approximately $15,000 within the first six months compared to oral metoclopramide.
Evoke continues to focus on improving patient outcomes and expanding access to Gimoti, which has been provided to over 4,000 patients since launch. The company is also positioning itself to respond to new challenges, such as gastroparesis linked to GLP-1 receptor agonists.
Positive
- Gimoti remains the only FDA-approved nasal spray treatment for acute and recurrent diabetic gastroparesis in adults
- Real-world data shows Gimoti users experienced 60% reduction in ER visits and 68% reduction in hospitalizations compared to oral metoclopramide
- Cost analysis revealed Gimoti reduced total care costs by approximately $15,000 within first six months compared to oral metoclopramide
- Over 4,000 patients have been provided with Gimoti since launch
Negative
- Failure of competitor's drug (Tradipitant) to gain FDA approval may slow market expansion for gastroparesis treatments
- treatment options for gastroparesis patients as 14 treatments in last 15 years have failed to gain regulatory clearance
Insights
The FDA's decision not to approve Tradipitant highlights the ongoing challenges in developing new treatments for gastroparesis. This reinforces Gimoti's position as the only FDA-approved nasal spray for diabetic gastroparesis. The real-world data presented at Digestive Disease Week 2023 is particularly noteworthy, showing significant reductions in ER visits (
Evoke Pharma's reaffirmation of commitment amid industry setbacks positions it favorably in the gastroparesis market. With 14 failed treatments in the last 15 years, Gimoti's unique FDA approval status becomes a significant competitive advantage. The company's focus on real-world data and cost-effectiveness strengthens its market position. The potential expansion into gastroparesis linked to GLP-1 receptor agonists represents a new growth opportunity. However, investors should note that while Gimoti has treated over 4,000 patients since launch, the company hasn't provided specific revenue figures, which would be important for assessing financial performance.
Evoke Pharma's strategic positioning in the gastroparesis market is noteworthy. The lack of FDA-approved alternatives strengthens Gimoti's market position. The company's focus on educating patients and physicians about non-oral treatments is a smart move to drive adoption. The real-world data showing improved outcomes over oral metoclopramide provides a strong selling point. The potential market expansion due to gastroparesis linked to GLP-1 receptor agonists presents a significant growth opportunity. However, the challenge lies in effectively scaling up market penetration and convincing more healthcare providers to prescribe Gimoti over traditional oral medications.
Gimoti remains the sole proprietary 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 focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, reaffirms its commitment to improving the lives of patients suffering from diabetic gastroparesis in light of the recent decision by the U.S. Food and Drug Administration (FDA) to not approve Vanda Pharmaceuticals new drug application (NDA) for Tradipitant, an oral drug candidate for the treatment of symptoms in gastroparesis. Patients suffering from all forms of gastroparesis need additional agents to help treat this difficult disease, and we believe patients will be disappointed given the FDA’s decision. Evoke continues to serve as 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 affect 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 seek to inform patients and physicians about the benefits of non-oral treatments for this disease.”
Diabetic gastroparesis is a serious condition and remains complex to effectively treat 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 complexities of gastroparesis. Oral treatments are prone to faulty absorption due to the delayed gastric emptying blocking delivery or symptoms causing vomiting of pills, further complicating oral drug therapy.
Those suffering from diabetic gastroparesis, who often take several oral medications, know first-hand the problems ingesting 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 gastroparesis field showing 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 using Gimoti experienced significant reductions in emergency room visits (-
Evoke Pharma’s commitment to quality and innovation continues to drive its mission to provide patients with reliable and effective treatments for gastroparesis. As the field evolves, particularly with the emergence of gastroparesis linked to GLP-1 receptor agonists, Evoke is positioning to respond to these new challenges with data to support clinical decision making.
“As we continue to explore the benefits of Gimoti in diabetic gastroparesis treatment, Evoke Pharma is striving to expand on our promise of providing innovative and accessible solutions for patients and healthcare providers,” said Chris Quesenberry, Chief Commercial Officer of Evoke. “While having additional therapies would be beneficial to patients and providers, it would also be supportive of Evoke’s goal to expanded diagnosis and treatment of patients, many of whom go years without a proper diagnosis or appropriate treatment. Gaining approval for a new treatment method has proven very difficult for gastroparesis. With this recent news, it brings the total to 14 treatments in last 15 years that have failed to gain regulatory clearance. We believe GIMOTI is an important new innovation for gastroparesis patients and we remain steadfastly committed to expanding our commercial reach to ensure more patients receive the clinical value and ability to return to normal daily activities,” he added.
About Evoke Pharma, Inc.
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.
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Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: healthcare provider and patient reactions to recent industry developments; future developments in the treatment landscape for diabetic gastroparesis; and Evoke’s commercialization plans. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke and EVERSANA may not be able to successfully drive market demand for GIMOTI; alternative treatments for gastroparesis may be developed and may be shown to be superior to GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor & Media Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: 862-213-1398
FAQ
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