Evoke Pharma and EVERSANA Expand Patient Access to GIMOTI® With New Telehealth Solution
The new Direct-to-Patient Technology Solution will leverage EVERSANA’s partnership with UpScriptHealth, a direct-to-consumer telehealth platform. The program allows patients who don’t have regular access to care due to their remote location, lack of transportation, affordability, or work schedule to access care via a telehealth option. UpScriptHealth’s telehealth solution provides access to care from a licensed board-certified healthcare provider when it is convenient, generally a same-day appointment with a healthcare provider. This may allow for more rapid consultation and potentially treatment initiation within just a few days, if medically appropriate.
People who have gastroparesis need options to support their ability to obtain relief of their symptoms that are often acute and debilitating. In a recent survey of patients with gastroparesis*:
- Over half reported their symptoms as being severe or very severe
- 60% were not satisfied with available treatments for gastroparesis.
- When asked about their overall medical care, 1 out of 4 reported being dissatisfied.
“This burden and the experience many people have with diabetic gastroparesis has compelled many patients to search for options online. We encourage patients to seek the best option for them, whether that is their own doctor or a motility expert. By offering a telehealth option, we believe we augment current care options and reach an important and significant portion of the diabetic gastroparesis patient population to provide access to care for this difficult disease,” explained Matt D’Onofrio, MBA, Evoke Pharma’s Chief Business Officer.
“This partnership with EVERSANA and UpScriptHealth provides another key channel through which we may meaningfully improve patient access to GIMOTI,” stated Matt D’Onofrio, MBA, Evoke Pharma’s Chief Business Officer. “GIMOTI fills a major treatment gap by providing the current standard of care treatment through a non-oral delivery. Adding direct-to-patient telehealth to the commercial support of the integrated commercial team from EVERSANA expands our ability to address this large and growing market.”
“UpScriptHealth looks forward to initiating this partnership and improving the accessibility of GIMOTI to people suffering from the symptoms of diabetic gastroparesis,” said
*Yu D, Ramsey FV, Norton WF, Norton N, Schneck S, Gaetano T, Parkman HP. The burdens, concerns, and quality of life of patients with gastroparesis. Dig Dis Sci. 2017 Jan 21. doi: 10.1007/s10620-017-4456-7
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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UpScriptHealth provides a direct-to-consumer Telehealth platform for pharmaceutical companies and consumer products companies allowing for convenient access to high quality health care. In 2002 we were the first company in the US to be licensed to write prescriptions on the internet through an online physician consultation. Since then we’ve treated more than a million consumers in all fifty states. Learn more at www.UpScriptHealth.com.
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 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 potential benefits of GIMOTI for patients with diabetic gastroparesis; the potential market for diabetic gastroparesis treatment; and Evoke’s and EVERSANA’s ability to increase access to and awareness of GIMOTI, including through the UpScriptHealth platform. 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; the UpScriptHealth platform may not drive additional patient access or prescriptions; Evoke’s ability to maintain Medicare coverage in various jurisdictions; the COVID-19 pandemic may continue to 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; 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.
Source: Evoke Pharma, Inc.