Evoke Pharma and EVERSANA Announce Support of The International Foundation for Gastrointestinal Disorders’ (IFFGD) August Gastroparesis Awareness Month

SOLANA BEACH, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma® (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA, a leading provider of global commercialization services to the life science industry, today announced support of the International Foundation for Gastrointestinal Disorders (IFFGD) August Gastroparesis Awareness Month and sponsorship for the upcoming Digestive Health Virtual Walk in honor of the organization’s 30th anniversary.

Alongside IFFGD, Evoke and EVERSANA aim to increase community awareness about gastroparesis during this month-long campaign. This disease, oftentimes linked to diabetes and its continued growth, is often poorly understood, while the number of people suffering from the condition continue to rise. IFFGD works to focus attention on important health messages about gastroparesis diagnosis, treatment, and quality of life issues. The goals include improving understanding of gastroparesis to help patients and families manage the condition and encouraging preventive strategies.

The Digestive Health Virtual Walk occurs this year and is currently open for registration. The walk will kick off August 21st, ending on September 4th, and 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. Aside from physical fitness, participants will also be encouraged to take part 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.

In addition to sponsoring the event, Evoke will actively participate, signing up under Team DGP-n-Me. To further support IFFGD, Evoke has made an additional donation that will allow access to members of the DGP-n-Me: Diabetic Gastroparesis Support Facebook page – a community dedicated to offering support, education, and advice to people living with symptoms of diabetic gastroparesis – the ability to register for free. Employees from Evoke and EVERSANA are also encouraged to show their support throughout the walk. Proceeds raised from the event will be contributed towards a research grant for gastrointestinal disorders.

“We have striven to bring our novel product, Gimoti®, to those that suffer from diabetic gastroparesis and created the EvokeAssist™ program to bring additional nursing and financial support to those in need. Gastroparesis Awareness month is an essential time to emphasize the need for community education and involvement around gastroparesis. We are excited to participate in this event by IFFGD and continue to participate in important community initiatives such as raising awareness and improving education for gastroparesis,” commented Matt D’Onofrio, MBA, Evoke’s Chief Business Officer. “We encourage members of the DGP-n-Me: Diabetic Gastroparesis Support Facebook Community to register for the walk under the Evoke team name and empower their journey.”

Evoke recently announced its membership into IFFGD’s Industry Council, alongside EVERSANA™, a leading provider of global commercial services to the life science industry. This council is a likeminded group of organizations and brands focused on bettering patients affected by GI disorders.

For more information, or to sign up, please visit: https://iffgd.org/get-involved/make-moves-for-gi-health/.

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 EVERSANA

EVERSANA™ is the leading 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 science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

About IFFGD

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.

To learn more about IFFGD, please visit: Website: www.iffgd.org Facebook: www.facebook.com/IFFGD Twitter: www.twitter.com/IFFGD

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 size of the gastroparesis market and the potential of GIMOTI to treat patients with diabetic gastroparesis. 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 and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations, including through the EVERSANA line of credit which is subject to certain customary conditions; the COVID-19 pandemic may disrupt Evoke’s and EVERSANA’s business operations impairing the ability to commercialize GIMOTI and Evoke’s ability to generate any product revenue; 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 obtain and maintain intellectual property protection for GIMOTI; and other risks 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 Contact:
The Ruth Group
Christine Petraglia
Tel: 917-633-8980
cpetraglia@theruthgroup.com

Media Contact:
The Ruth Group
Annika Parrish
Tel: 720-412-9042
aparrish@theruthgroup.com

EVERSANA Contact:
Sarah Zwicky
Tel: 414-434-4691
Sarah.zwicky@eversana.com

Source: Evoke Pharma, Inc.


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