Evoke Pharma Highlights GIMOTI as a Leading Solution for Gastroparesis Treatment as Domperidone Supply Ends
Evoke Pharma (NASDAQ: EVOK) highlights GIMOTI's position as the only FDA-approved nasal spray for diabetic gastroparesis as domperidone supply is expected to end in early 2025. The FDA announced that efforts to find alternative domperidone sources have failed, emphasizing the need for approved therapies like GIMOTI.
Real-world data shows GIMOTI's effectiveness with a 60% reduction in emergency room visits and 68% decrease in hospitalizations compared to oral metoclopramide. Notably, 61% of GIMOTI patients were previously on oral metoclopramide, indicating improved benefits after switching to nasal delivery.
Domperidone, while used internationally, was never FDA-approved in the US due to safety concerns, particularly cardiac risks. GIMOTI's nasal delivery system bypasses GI tract issues, addressing delayed emptying in gastroparesis patients who struggle with oral medications.
Evoke Pharma (NASDAQ: EVOK) mette in evidenza la posizione di GIMOTI come l'unico spray nasale approvato dalla FDA per la gastroparesi diabetica, poiché si prevede che la fornitura di domperidone termini all'inizio del 2025. La FDA ha annunciato che gli sforzi per trovare fonti alternative di domperidone sono falliti, sottolineando la necessità di terapie approvate come GIMOTI.
Dati del mondo reale mostrano l'efficacia di GIMOTI con una riduzione del 60% delle visite al pronto soccorso e un calo del 68% dei ricoveri ospedalieri rispetto al metoclopramide orale. È importante notare che il 61% dei pazienti trattati con GIMOTI era precedentemente in terapia con metoclopramide orale, indicando un miglioramento dei benefici dopo il passaggio alla somministrazione nasale.
Il domperidone, pur essendo utilizzato a livello internazionale, non ha mai ottenuto l'approvazione della FDA negli Stati Uniti a causa di preoccupazioni per la sicurezza, in particolare per i rischi cardiaci. Il sistema di somministrazione nasale di GIMOTI evita i problemi del tratto gastrointestinale, affrontando il ritardo nell'emissione nei pazienti con gastroparesi che hanno difficoltà con i farmaci orali.
Evoke Pharma (NASDAQ: EVOK) resalta la posición de GIMOTI como el único spray nasal aprobado por la FDA para la gastroparesis diabética, ya que se espera que el suministro de domperidona finalice a principios de 2025. La FDA anunció que los esfuerzos por encontrar fuentes alternativas de domperidona han fracasado, enfatizando la necesidad de terapias aprobadas como GIMOTI.
Los datos del mundo real muestran la efectividad de GIMOTI con una reducción del 60% en visitas a salas de emergencia y una disminución del 68% en hospitalizaciones en comparación con metoclopramida oral. Cabe destacar que el 61% de los pacientes con GIMOTI estaban previamente en metoclopramida oral, lo que indica beneficios mejorados después de cambiar a la administración nasal.
La domperidona, aunque se utiliza internacionalmente, nunca estuvo aprobada por la FDA en los Estados Unidos debido a preocupaciones sobre la seguridad, en particular los riesgos cardíacos. El sistema de entrega nasal de GIMOTI evita los problemas del tracto gastrointestinal, abordando el retraso en el vaciamiento en pacientes con gastroparesis que tienen dificultades con los medicamentos orales.
에보크 파마(Evoke Pharma) (NASDAQ: EVOK)는 도메페리돈 공급이 2025년 초에 종료될 것으로 예상됨에 따라, GIMOTI가 당뇨병성 위마비에 대한 유일한 FDA 승인 코 세척 스프레이임을 강조합니다. FDA는 대체 도메페리돈 출처를 찾기 위한 노력이 실패했다고 발표하며, GIMOTI와 같은 승인된 치료법의 필요성을 강조했습니다.
실제 데이터는 GIMOTI의 효과를 보여주며, 응급실 방문이 60% 감소하고 입원율이 경구 메토클로프라미드에 비해 68% 감소했습니다. 특히, GIMOTI 환자의 61%가 이전에 경구 메토클로프라미드를 복용하고 있었으며, 이는 비강 전달로 전환한 후 개선된 혜택을 나타냅니다.
도메페리돈은 국제적으로 사용되지만, 미국에서는 안전 문제, 특히 심장 위험으로 인해 FDA 승인을 받지 못했습니다. GIMOTI의 코 스프레이 시스템은 위장 문제를 우회하여 경구 약물이 어려운 위마비 환자의 배출 지연을 해결합니다.
Evoke Pharma (NASDAQ: EVOK) met en lumière la position de GIMOTI en tant que seul spray nasal approuvé par la FDA pour la gastroparesie diabétique, alors que l'approvisionnement en dompéridone devrait se terminer au début de 2025. La FDA a annoncé que les efforts pour trouver des sources alternatives de dompéridone avaient échoué, soulignant le besoin de thérapies approuvées comme GIMOTI.
Les données du monde réel montrent l'efficacité de GIMOTI avec une réduction de 60 % des visites aux urgences et une baisse de 68 % des hospitalisations par rapport à la métoclopramide orale. Notamment, 61 % des patients ayant utilisé GIMOTI étaient auparavant sous métoclopramide oral, indiquant des bénéfices améliorés après le passage à l'administration nasale.
La dompéridone, bien qu'elle soit utilisée à l'international, n'a jamais été approuvée par la FDA aux États-Unis en raison de préoccupations de sécurité, notamment des risques cardiaques. Le système de livraison nasal de GIMOTI contourne les problèmes du tractus gastro-intestinal, en répondant au retard d'évacuation chez les patients souffrant de gastroparesie qui ont des difficultés avec des médicaments oraux.
Evoke Pharma (NASDAQ: EVOK) hebt die Stellung von GIMOTI als das einzige von der FDA zugelassene Nasenspray für diabetische Gastroparese hervor, da erwartet wird, dass die Versorgung mit Domperidon Anfang 2025 endet. Die FDA kündigte an, dass die Bemühungen, alternative Domperidonquellen zu finden, gescheitert sind, und betonte die Notwendigkeit genehmigter Therapien wie GIMOTI.
Reale Daten zeigen die Wirksamkeit von GIMOTI mit einer Reduzierung der Notaufnahmen um 60 % und einem Rückgang der Krankenhausaufenthalte um 68 % im Vergleich zu oralem Metoclopramid. Bemerkenswert ist, dass 61 % der GIMOTI-Patienten zuvor mit oralem Metoclopramid behandelt wurden, was auf verbesserte Vorteile nach dem Wechsel zur nasalen Verabreichung hinweist.
Domperidon wurde international verwendet, war jedoch aufgrund von Sicherheitsbedenken, insbesondere Herzrisiken, nie von der FDA in den USA zugelassen. GIMOTIs nasales Liefer-system umgeht Probleme im Magen-Darm-Trakt und behebt die verzögerte Entleerung bei Gastroparese-Patienten, die Schwierigkeiten mit oralen Medikamenten haben.
- 60% reduction in emergency room visits compared to oral metoclopramide
- 68% decrease in hospitalizations compared to oral metoclopramide
- Only FDA-approved nasal spray treatment for diabetic gastroparesis
- Significant reduction in overall healthcare costs
- None.
Insights
The discontinuation of domperidone supply through FDA's expanded access program creates a significant market opportunity for GIMOTI. The real-world evidence showing
The nasal delivery system strategically addresses the fundamental challenge in gastroparesis treatment - oral medication absorption issues due to delayed gastric emptying. This differentiation is particularly valuable given the treatment landscape and domperidone's exit. With an estimated 5-6 million Americans affected by gastroparesis and diabetes being a major risk factor, GIMOTI's positioning as the only FDA-approved non-oral therapy represents substantial untapped market potential.
For EVOK, with a micro-cap valuation of
The timing is particularly advantageous as it allows physicians to transition patients before domperidone supply exhaustion in early 2025. This could catalyze near-term revenue growth. The real-world evidence showing superior outcomes versus oral metoclopramide provides compelling economic justification for prescription and reimbursement, potentially driving both volume growth and pricing power.
FDA posts update as mechanism to obtain unapproved Domperidone expected to lose supply in early 2025
Gimoti remains only approved drug shown to reduce hospitalizations, emergency room and medical office visits and related costs compared to oral metoclopramide
SOLANA BEACH, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, underscores its commitment to patients and healthcare providers managing gastroparesis in light of FDA’s recent update regarding domperidone supply. As the sole FDA-approved nasal spray treatment for acute and recurrent diabetic gastroparesis in adults, GIMOTI® (metoclopramide) is uniquely positioned to address the ongoing needs of patients facing challenges with alternative therapies.
The FDA recently posted: “Efforts made in the interim to identify an alternative source [of domperidone] have been unsuccessful. The current supply will be exhausted as early as the first or second quarter of 2025, at which time this program will no longer be able to supply domperidone for treatment use under your expanded access IND. FDA understands that this may pose challenges as you continue to care for your patient(s). We are making you aware of this development now so that you may begin to explore other treatment strategies.” (https://www.fda.gov/drugs/investigational-new-drug-ind-application/how-request-domperidone-expanded-access-use)
Domperidone, while used internationally for gastroparesis treatment and other GI conditions, has never been approved for use in the United States due to safety concerns, particularly its association with cardiac arrhythmias and sudden cardiac death. Despite this, some patients accessed domperidone under FDA’s expanded access program when other treatments proved insufficient. FDA's recent announcement regarding the discontinuation of domperidone supply further highlights the urgent need for safe, effective, and accessible therapies like GIMOTI for patients struggling with gastroparesis.
Gastroparesis is a debilitating GI disorder wherein delayed stomach emptying, causes significant nausea, vomiting, early satiety, and abdominal pain often leading to dehydration, malnutrition and frequent ER visits and hospitalizations. These patients, particularly those who struggle eating a solid meal, often have issues taking oral medications either because they cannot easily take medicine (difficulty swallowing) may not keep medicines down (nausea and vomiting) or will not absorb medicine (due to delayed gastric emptying). Having effective treatments and routes of administration that can deliver medicine reliably are increasingly important.
Patient Advocate, Melissa VanHouten, stressed, “This news will have a negative impact on the gastroparesis community, so it is critically important to communicate this change to patients and their providers. People with gastroparesis had very few options prior to this news and the fact that there is only one FDA approved compound remaining for my community is unacceptable. That said, it is important for patients and providers to re-educate themselves about the options that are available, like oral metoclopramide and GIMOTI, and for all stakeholders to reduce the barriers to access to these and other medications that will improve their quality of life.”
Matt D’Onofrio, CEO of Evoke Pharma, commented, “FDA’s recent announcements highlight the critical need for reliable treatment options for patients. We believe GIMOTI addresses many needs of patients with gastroparesis and diabetes through its unique nasal spray delivery. It remains the only non-oral therapy that bypasses the GI tract, addressing the core defect of delayed emptying, and provides a practical and proven solution to relieve symptoms”
Strong Real-World Evidence Supports GIMOTI’s Commercial Promise
Evoke Pharma remains committed to driving innovation and delivering value to patients, providers, and payors with strong supportive evidence. Real-world data has demonstrated significant clinical benefits of GIMOTI, including a
Mr. D’Onofrio added, “We are proud to support patients and providers with GIMOTI, a treatment that combines innovation with proven efficacy. As alternative treatment options like domperidone become unavailable or harder to access, GIMOTI’s unique value proposition becomes even clearer, providing reliable symptom relief and improving quality of life for gastroparesis patients without a major burden on healthcare resources, patients, or payors.”
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 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 (≥
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: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, the potential market opportunity for GIMOTI, Evoke’s partnership with ASPN Pharmacies, growth in prescriptions, patients taking GIMOTI and the conversion of prescriptions to fills, and Evoke’s expected cash runway. 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 may not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; 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; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; 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 maintain intellectual property protection for GIMOTI; 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 & Media Contact:
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FAQ
When will domperidone supply end according to FDA's update affecting EVOK?
What are the key clinical benefits of GIMOTI compared to oral metoclopramide for EVOK?
Why was domperidone never FDA-approved in the United States?
What percentage of GIMOTI patients were previously on oral metoclopramide?
How does GIMOTI's delivery method differ from traditional gastroparesis treatments?
