Evoke Pharma and EVERSANA Announce Positive Findings from GIMOTI® Market Research Study

Rhea-AI Summary

Evoke Pharma (NASDAQ: EVOK) announced positive results from a recent market study on its GIMOTI® (metoclopramide) nasal spray. Conducted by EVERSANA, the study revealed that 92% of healthcare practitioners intend to prescribe GIMOTI, up from previous surveys. Key findings highlight a shift in preference for nasal administration over oral, with 45% of gastroenterologists favoring this route. The company will present these insights at the ACG Conference in Las Vegas on October 22-27, 2021.

Positive

• 92% of healthcare practitioners intend to prescribe GIMOTI, an increase from prior studies.
• Preference for nasal route of administration increased, with 45% of gastroenterologists favoring it over oral.

Negative

• None.

Health care practitioners’ perception of nasal route of administration similar to IV; 92% intend to prescribe GIMOTI

Evoke attending American College of Gastroenterology (ACG) Annual Conference in Las Vegas, October 22-27, 2021

SOLANA BEACH, Calif. and CHICAGO, Oct. 20, 2021 (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 a recent market research study conducted for GIMOTI^® (metoclopramide) nasal spray. The study aimed to gather additional market insights on the perception of GIMOTI in the Gastroenterology and other health care provider communities during September 2021 and follows prior market research studies conducted since product launch. Evoke will share the findings in discussions at the upcoming American College of Gastroenterology (ACG) Conference, an important gastroenterology conference focused on clinical practice, being held October 22 - 27 in Las Vegas, NV.

Last month, Evoke’s commercialization partner, EVERSANA, conducted the GIMOTI Awareness, Trial, and Usage (ATU) Study with healthcare practitioners (HCPs). The quantitative study objectives were to understand the current gastroparesis treatment landscape and to evaluate health care practitioners’ perceptions of GIMOTI following recent brand marketing efforts. The ATU survey was divided into four sections: current approach to treating diabetic gastroparesis (DGP), prescribing behavior, treatment awareness, and additional perspectives around supportive resources.

The respondent mix included 65 gastroenterologists (GEs) currently being called on by the field sales force, 53 GEs and primary care physicians (PCPs) who are not currently targeted for in person messaging, but whom may be targeted through our online digital and social campaign, and an additional 10 nurse practitioners and physician assistants, whom were added to the most current wave of the survey in response to the significant collaborative and independent role they play in the diagnosis and medical treatment and follow-up with diabetic gastroparesis patients.

Key findings, including select data point comparisons from the ATU Study previously conducted are outlined below.

Key Findings:

• Continued increase in intent to prescribe GIMOTI:
   -- 92% of all respondents intend to prescribe GIMOTI in the future
  • 90% of targeted GEs; compared to 79% in previous study
  • 86% of non-targeted GEs; compared to 89% in previous study
  • 100% of PCPs; compared to 50% in previous study
  • 100% of NP/PAs; first time queried in this ATU study

• Targeted GEs now report “Nasal” (45%) as the preferred route of medication administration for gastroparesis patients over “Oral” (26%).
• Targeted GEs report greater GIMOTI usage across first, second and third lines of treatment from the December 2020 study, with the similar use as a third-line treatment option at around 22%.
• Similar to the previous study, GEs indicated a moderate-to-high level of concern about a diabetic gastroparesis patient’s ability to absorb oral medications with more than half of respondents indicating that 21%-60% of their patients have trouble ingesting and/or digesting oral medications.
• The percentage of targeted GEs reporting high awareness of GIMOTI (scoring a 4 or 5 out of 5) has increased from 21% in December 2020 to 54% in September 2021.

A chart accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7ad1d96e-28fb-4769-a871-85f9650e8476

“These latest ATU study findings are supportive of both our call point strategy and the messaging to targeted physicians as they confirm increasing awareness and rationale for usage of GIMOTI. Our sales force continues to gain improved access to targeted physician offices to conduct face to face discussions and uncover the needs of diabetic gastroparesis patients who continue to suffer from this disease. These results provide meaningful insights for our commercial team’s understanding of how and when our marketing efforts are being captured by targeted health care providers,” commented David Gonyer, R.Ph., Evoke Pharma President and CEO. “We remain convinced that GIMOTI can help answer a critical unmet medical need and look forward to sharing our findings with other prominent GEs at the upcoming ACG Conference later this month.”

“GIMOTI has made a huge difference in my patients with diabetic gastroparesis. Their nausea-vomiting is usually resolved pretty quickly, which is usually the most troubling and most damaging symptom in their lives. They're able to eat as the early-satiety goes down and it improves the bloating/abdominal pain, because it's working as a prokinetic, that also allows them to live a somewhat normal life,” stated Viplove Senadhi, MD, Greater Montgomery Patient Centered Gastroenterology and Hepatology, in Montgomery, AL. “For me, this is a paradigm shift for my patients in my practice, showing the quick efficacy, the lasting ability, and the ability to acutely affect patients with nausea-vomiting with a new modality to treat them. It's actually changed my standard of care.”

“These most recent studies we conducted measured an expanded awareness and adoption of GIMOTI as we continue to build GIMOTI’s presence within the market. These data are a significant leading indicator that our promotional efforts are gaining traction and that our messages are resonating, especially with targeted gastroenterologists and advance practice providers who provide the majority of care for patients with diabetic gastroparesis,” added Chris Quesenberry, Chief Commercial Officer. “The results of the market research follow the positive reception we received from physicians who express a desire for an alternative to existing oral therapies. They indicate that a nasal route of administration that can bypass the GI tract makes sense for this underserved patient population. We believe this positive perception is being fueled by patient use of GIMOTI and the feedback patients are sharing with their providers.” I am particularly encouraged that we are strengthening high familiarity of GIMOTI with HCPs and also that the perception of efficacy is high, which is leading to stated increase in prescribing across all patient types, most notably switches from oral therapies and first-line use.”

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.

Follow GIMOTI on Facebook: https://www.facebook.com/GIMOTI-metoclopramide-nasal-spray-104672345100289

Follow Evoke Pharma on Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724

Follow Evoke Pharma on LinkedIn: https://www.linkedin.com/company/evoke-pharma/

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.

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: potential future prescribing trends for GIMOTI based on this survey of GIs and PCPs or Evoke’s marketing efforts; and Evoke’s commercialization plans, including its 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.

Investor Contacts:
The Ruth Group
Christine Petraglia
Tel: 917-633-8980
cpetraglia@theruthgroup.com

Media Contact:
The Ruth Group
Daniel Kontoh-Boateng
Tel: 646-536-7019
dboateng@theruthgroup.com

Source: Evoke Pharma, Inc.

FAQ

What were the key findings of the GIMOTI market study conducted by Evoke Pharma?

The study found that 92% of healthcare practitioners intend to prescribe GIMOTI, with a growing preference for the nasal route over oral administration.

When is Evoke Pharma presenting its GIMOTI findings at the ACG conference?

Evoke Pharma will present its findings at the ACG Conference in Las Vegas from October 22-27, 2021.

How has the perception of GIMOTI changed among physicians?

The perception of GIMOTI has improved, with 54% of targeted gastroenterologists reporting high awareness, up from 21% previously.

What is the significance of the GIMOTI nasal spray for diabetic gastroparesis patients?

GIMOTI offers an alternative route that bypasses the gastrointestinal tract, addressing the challenges of oral medication absorption in diabetic gastroparesis patients.