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Research Study Among Patients Demonstrated Favorable Acceptance and Utilization of GIMOTI
SOLANA BEACH, Calif. and CHICAGO, May 18, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA™, a leading provider of global commercial services to the life science industry, today announced positive findings from the first patient-centered survey related to GIMOTI. Following the series of market insights gathered on the perception of GIMOTI by prescribers (primarily gastroenterologists, nurse practitioners/physicians assistants and some primary care doctors), a research study was initiated to capture patient responses on their individual gastroparesis (GP) experiences and feedback on current treatment options.
In April 2022, EVERSANA conducted the patient segment of the GIMOTI Awareness, Trial, Usage (ATU) Study, a quantitative survey designed to measure patient awareness, trial, and product usage of GIMOTI. This first wave of the ATU patient survey was centered around three major themes: symptoms and diagnosis, feedback on existing medications, and their experiences with GIMOTI.
The blinded survey was completed with 110 patients who represented a diverse range of age, gender, racial background, geographic locations and diabetes subtypes. Majority of the respondents were between 19-65 years old. The respondents were predominantly Caucasian with a higher sample of female patients, consistent with the demographics of GP patients generally.
Roughly 50% of users do not see any symptom improvement from existing oral treatment options (liquid or tablet forms)
38% of respondents discontinued their GP medications primarily due to either side effects or lack of symptom improvement
Of those respondents who were aware of GIMOTI prior to the survey, 43% are current users
100% of current GIMOTI users report seeing at least some symptom improvement; diminished nausea is the most cited symptom improvement
“These data, gathered from patients, are promising and indicative of the robust and significant need for additional therapies for patients with gastroparesis and the potential value that GIMOTI may provide,” commented Matt D’Onofrio, MBA, Chief Business Officer of Evoke Pharma. “Since the launch of our Patient and Physician Experience Program, we have accumulated insights that align with our commercial strategy and mission to deliver a treatment alternative to gastroparesis patients that meets their needs and provides them symptomatic relief that is often elusive. Patient empowerment is paramount to our business, and we are motivated, more than ever, to bring GIMOTI front and center for patients.”
“We are investing significantly in educating patients about their disease and how they can advocate for better treatment. It is critical that patients understand there are non-oral options, like GIMOTI, that avoid the unpredictability of their gastric tract and don’t rely on oral medication absorption. This market research will allow us to track our progress in growing patient awareness, which is increasing, as well as monitor the perceptions of GIMOTI. These data indicate GIMOTI has a place in the treatment paradigm for patients with diabetic gastroparesis and support our contention that it is the optimal treatment for these patients based on its novel route of administration,” added Chris Quesenberry, Chief Commercial Officer.
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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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.
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 for GIMOTI to meet the needs of patients and Evoke’s and EVERSANA’s marketing efforts; and Evoke’s and EVERSANA’s commercialization plans, including their plans to increase awareness and access to GIMOTI. 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 results of the ATU survey may not predict prescribing trends by doctors or acceptance by patients, and are not intended to reflect or imply actual prescriptions or sales to date; Evoke’s ability to obtain additional financing as needed to support its operations; 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.