Event features the year’s best abstracts and experts across digestive disease states
SOLANA BEACH, Calif., and CHICAGO, IL., February 21, 2023 – 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, and EVERSANA™, a leading provider of global commercial services to the life science industry, today announced that its abstract entitled “Reducing Real-World Healthcare Resource Utilization For Patients With Diabetic Gastroparesis (DGP) Treated with Metoclopramide Nasal Spray Versus Oral Metoclopramide” has been selected for the plenary lecture presentation at the upcoming Digestive Disease Week (DDW 2023). The meeting will take place May 6-9, 2023 at McCormick Place in Chicago, IL.
The abstract will be delivered in an oral plenary presentation by David C. Kunkel, MD, Gastroenterologist and Associate Professor of Medicine at UC San Diego Health. Sessions at DDW are the forum for highlighting some of the year’s best research abstracts as determined by the conference organizers. The presentation will highlight data from a retrospective cohort analysis of 514 diabetic gastroparesis patients comparing those receiving either GIMOTI or oral metoclopramide to determine the relative usage of healthcare resources across all settings (such as doctor’s offices, emergency rooms, and inpatient and outpatient hospital visits versus after initiation of therapy).
GIMOTI is the first and only FDA-approved nasal formulation of metoclopramide that is commercially available and specifically designed to deliver a non-oral dose of metoclopramide for the relief of symptoms in adults with acute and recurrent DGP. Prior to GIMOTI’s approval by the U.S. Food and Drug Administration (FDA), oral metoclopramide was the only FDA-approved outpatient treatment for patients suffering from DGP. A nasal route of administration offers systemic absorption in patients with gastroparesis where gastric emptying can be erratic and absorption can be unpredictable.
“The data to be presented at DDW will speak to the true potential of GIMOTI and its effectiveness for gastroparesis patients,” said Dr. Kunkel, Gastroenterologist and Associate Professor of Medicine at UC San Diego Health. “Patients suffering from diabetic gastroparesis run the high risk of visiting the hospital or ER frequently due to a plethora of symptoms associated with the debilitating condition. I am thrilled to share with my colleagues and distinguished members of the DDW community this compelling data based on a novel product that I believe can move the needle in the gastroparesis treatment landscape.”
“Our core objective when we began this journey well over a decade ago to bring a novel product like GIMOTI to the market was to help change the trajectory of gastroparesis treatment by providing a critically needed non-oral drug delivery for gastroparesis. Today, with the clinical and commercial validation we are receiving for GIMOTI, we could not be prouder to share these data at DDW and show that we are indeed attaining our patient-centric goal,” commented Matt D’Onofrio, President and COO of Evoke Pharma.
“The value of real-world evidence has never been more important to demonstrate the effectiveness of novel therapies like GIMOTI,” added Jim Lang, CEO at EVERSANA. “Through our robust data sets and experts at EVERSANA, we’re able to assess the impact of GIMOTI across multiple stakeholders, including doctors, payers and patients across diverse demographic and clinical settings.”
Details of the presentation are as follows:
Distinguished Plenary Presentation Title: “Reducing Real-World Healthcare Resource Utilization for Patients with Diabetic Gastroparesis (DGP) Treated with Metoclopramide Nasal Spray Versus Oral Metoclopramide”
Presentation Date & Time: May 9, 2023, from 8:00 AM to 9:30 AM CDT
Presenter: Dr. David C. Kunkel, Gastroenterologist and Associate Professor of Medicine at UC San Diego Health
Location: McCormick Place, Chicago, IL
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.
EVERSANA™ is the leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.
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: the anticipated scope and term of any patent protection for GIMOTI; and Evoke’s belief in the strength of the GIMOTI patent protection and ability to defend its intellectual property rights. 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’s ability to obtain, maintain and successfully enforce intellectual property protection for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke is entirely dependent on the success of 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.