Extends commitment toward supporting patients experiencing Diabetic Gastroparesis through focused collaborations and Sponsorship of the 30th Anniversary Digestive Health Virtual Walk
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, EVERSANA™, a leading provider of global commercial services to the life science industry, and The International Foundation for Gastrointestinal Disorders (IFFGD), today announced Evoke’s membership into IFFGD’s Industry Council. Evoke will join a likeminded group of organizations and brands focused on bettering patients affected by GI disorders. As part of the Industry Council, Evoke will participate in biannual council meetings to gain industry insights and provide feedback on future plans for IFFGD.
In addition to the Industry Council, Evoke is excited to sponsor the IFFDG’s upcoming 30th Anniversary Digestive Health Virtual Walk in August 2021 during Gastroparesis Awareness Month. This walk is a unique fitness event which will provide participants with an opportunity to engage at their own pace and as their health and schedules permit. To honor the thirty years of the IFFGD’s existence, the overall campaign goal is for all participants to collectively walk 10,950 miles over two weeks. Goals will also go beyond physical fitness by encouraging participants to participate in activities that promote general wellness such as scheduling a doctor’s appointment, trying a new gut friendly recipe or starting a log of their meals and/or symptoms.
“We appreciate Evoke Pharma joining in our efforts to support patients with digestive diseases, specifically those afflicted with gastroparesis. As there has been no new and novel treatments for this debilitating disease on the market in over 40 years, our community is seeking new options and support for patients,” stated Ceciel T. Rooker, President of IFFGD. “We recognize the significant unmet medical need that these patients have for improved treatment options. We look forward to Evoke’s contribution to our cause as we partner to help those in need.”
“We are excited to further extend our commitment to improving the lives of those affected by gastroparesis through our membership into the IFFGD’s Industry Council,” commented Matt D’Onofrio, Evoke Pharma Chief Business Officer. “The IFFGD provides an invaluable service to those impacted by chronic digestive disorders by raising awareness, improving education, and promoting research into treatments and cures. We look forward to working closely with an organization that is aligned with our mission, such as the IFFGD, and sponsoring its upcoming 30th Anniversary Digestive Health Virtual Walk.”
About Gimoti™ (metoclopramide) nasal spray
GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Important Safety Information
BOXED 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% of patients in clinical studies) for GIMOTI were dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. This information should not take the place of you talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about GIMOTI, talk to your doctor or pharmacist. Only you and your healthcare professional can decide if GIMOTI is right for you.
You report side effects related to Evoke Pharma products by calling 1-833-4-GIMOTI (1-833-444-6684) or emailing GIMOTImedinfo@evokepharma.com. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. Evoke developed 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.
About EVERSANA Life Science Services, LLC
EVERSANA™ is a leading provider of global services to the life science industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product lifecycle 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 science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.
The International Foundation for Functional Gastrointestinal Disorders (IFFGD) is a nonprofit education and research organization dedicated to improving the lives of people affected by a chronic gastrointestinal disorder. Founded in 1991, IFFGD helps improve care by enhancing awareness, improving education, and supporting and encouraging research into treatments and cures for chronic digestive disorders.
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 Evoke’s current beliefs and expectations. These forward-looking statements include statements regarding Evoke’s plans to increase awareness of GI disorders. 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 those described in Evoke’s periodic filings with the SEC. 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.
The Ruth Group