Evoke Pharma to Present New Data Comparing Tardive Dyskinesia Incidence in Continuous vs Intermittent Metoclopramide Use at DDW 2025

Rhea-AI Summary

Evoke Pharma (NASDAQ: EVOK) has announced the acceptance of a new abstract for presentation at Digestive Disease Week® (DDW) 2025, scheduled for May 3-6, 2025, in San Diego. The research compares tardive dyskinesia (TD) incidence in patients receiving continuous versus intermittent oral metoclopramide treatment.

The analysis, based on real-world data from over 100 million U.S. patients, examines TD incidence rates and timing related to different metoclopramide dosing patterns. The presentation, led by Dr. Pierantonio Russo from EVERSANA Life Sciences, is scheduled for May 5, 2025, from 12:30-1:30 p.m. PT.

CEO Matt D'Onofrio emphasized the importance of understanding metoclopramide's long-term safety profile, particularly for GIMOTI®, the only FDA-approved treatment for diabetic gastroparesis. The abstract will be available through the DDW ePosters site and meeting planner after May 4, 2025. Visitors can learn more at Evoke Pharma's booth #917 during the conference.

SOLANA BEACH, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI^®, today announced that a new abstract comparing the incidence of tardive dyskinesia (TD) in patients receiving continuous versus intermittent oral metoclopramide (OMCP) treatment has been accepted for presentation at Digestive Disease Week^® (DDW) 2025, taking place May 3–6, 2025, in San Diego, CA.

The analysis leverages real-world data from over 100 million U.S. patients and highlights differences in TD incidence rates and timing based on metoclopramide dosing patterns.

“This research builds on our ongoing commitment to understanding metoclopramide’s long-term safety profile,” said Matt D’Onofrio, CEO of Evoke Pharma. “As the only FDA-approved treatment for diabetic gastroparesis, it’s critical that we continue evaluating both efficacy and safety, particularly around concerns like tardive dyskinesia. This real-world data helps clarify risk profiles and supports more informed prescribing decisions for physicians interested in Gimoti. We’re excited to share these findings with the DDW community.”

Details of the poster presentation are as follows:

Abstract Title: Comparison of the Incidence of Tardive Dyskinesia in Patients Receiving Continuous vs Intermittent Oral Metoclopramide

Presenter & Lead Author: Pierantonio Russo, MD, EVERSANA Life Sciences

Presentation Session: Gastroparesis and Small Intestinal Dysmotility

Date & Time: Monday, May 5, 2025, from 12:30 – 1:30 p.m. PT

The abstract will be available via the DDW ePosters site and accessible to attendees through the DDW meeting planner and mobile app after 12:01 a.m. PT on Sunday, May 4, 2025.

Visit Evoke Pharma at DDW 2025:
To learn more about GIMOTI and our latest research, visit Evoke Pharma at booth #917 during DDW.

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.

Visit www.EvokePharma.com for more information.

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About Digestive Disease Week^® (DDW)

Digestive Disease Week^® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and 1,000 invited talks on the latest advances in GI research, medicine, and technology. More information can be found at www.ddw.org.

About Gimoti^® (metoclopramide) nasal spray

GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information

WARNING: TARDIVE DYSKINESIA

• Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
• Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
  

GIMOTI is not recommended for use in:

• Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
• Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.

GIMOTI is contraindicated:

• In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
• When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).
• In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
• In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.
• In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
  

Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, the potential market opportunity for GIMOTI, Evoke’s partnership with ASPN Pharmacies, growth in prescriptions, patients taking GIMOTI and the conversion of prescriptions to fills, and Evoke’s expected cash runway. 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 may not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; 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
dboateng@dkbpartners.net

FAQ

What is the focus of Evoke Pharma's new research presentation at DDW 2025?

The research compares tardive dyskinesia incidence rates between continuous and intermittent oral metoclopramide treatment, analyzing real-world data from over 100 million U.S. patients.

When and where will Evoke Pharma present their metoclopramide safety data at DDW 2025?

The presentation will take place on Monday, May 5, 2025, from 12:30-1:30 p.m. PT at DDW 2025 in San Diego, CA.

What is the significance of GIMOTI in Evoke Pharma's product portfolio?

GIMOTI is the only FDA-approved treatment for diabetic gastroparesis, making its safety profile, particularly regarding tardive dyskinesia risk, important for prescribing decisions.

How extensive is the patient data analyzed in Evoke Pharma's tardive dyskinesia study?

The study analyzes real-world data from over 100 million U.S. patients, examining TD incidence rates and timing based on metoclopramide dosing patterns.

Where can investors and healthcare professionals find Evoke Pharma at DDW 2025?

Evoke Pharma will be exhibiting at booth #917 during DDW 2025, where visitors can learn more about GIMOTI and their latest research.