Gimoti (metoclopramide intranasal) / Evoke Pharma - LARVOL DELTA

NMCP Delayed Time to Hospital Encounter and Reduced Cost compared to OMCP in Patients with Gastroparesis - A Real World Study (ISPOR 2025) - "An intranasal metoclopramide (NMCP) formulation offers a non-oral alternative for patients with reduced oral medication efficacy or as initial treatment... NMCP reduced healthcare costs by decreasing hospitalizations and ED visits, highlighting its value in GP management. Further research is planned to confirm long-term cost-effectiveness and identify key cost-saving drivers."

Clinical • Real-world • Real-world evidence • Diabetes • Gastrointestinal Disorder • Metabolic Disorders

Evoke Pharma to Present New Data Comparing Tardive Dyskinesia Incidence in Continuous vs Intermittent Metoclopramide Use at DDW 2025 (GlobeNewswire) - "Evoke Pharma, Inc...announced that a new abstract comparing the incidence of tardive dyskinesia (TD) in patients receiving continuous versus intermittent oral metoclopramide (OMCP) treatment has been accepted for presentation at Digestive Disease Week (DDW) 2025, taking place May 3–6, 2025, in San Diego, CA...The analysis leverages real-world data from over 100 million U.S. patients and highlights differences in TD incidence rates and timing based on metoclopramide dosing patterns."

Real-world • Real-world evidence • Gastroenterology

Safety of GLP-1 Agonists With Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis: Insights From a Phase 3 Study (ACG 2024) - "The GLP-1 drugs were those available in 2016 and included; liraglutide, canagliflozin, exenatide, dapagliflozin, empagliflozin, and repaglinide. Of the 36 patients, 34 (94%) completed the study. Two patients who did not complete the study were in the placebo group: one discontinued after the first dose due to an abnormal EKG, and the other after five days to use a protocol-excluded allergy medication. No serious adverse events (SAEs) were reported."

Clinical • P3 data • Diabetes • Gastrointestinal Disorder • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Pain • Pruritus

Addressing an Emerging Clinical Need: Nasal Metoclopramide's Impact on Diabetic Gastroparesis in Patients Taking GLP-1 Agonists (ACG 2024) - "The subgroup included 51 NMCP and 41 OMCP patients with a prior GLP-1 prescription. NMCP patients were slightly older (55.1 vs. 53.1 years) and had more pre-index hospitalization/ED admissions (31.4% vs."

Clinical • Diabetes • Gastrointestinal Disorder • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

TRANSFORMING DIABETIC GASTROPARESIS CARE IN WOMEN: INSIGHTS FROM NASAL METOCLOPRAMIDE USAGE (DDW 2024) - "Female DGP patients treated with NMCP experienced significantly fewer DGP-related healthcare visits including physician offices ED and hospitalizations. The likelihood of a female DGP patient treated with NMCP being admitted to the hospital was less than a third of women treated with OMCP during the same period and that of a visit to the ED or outpatient was less than half. The efficacy of NMCP in reducing hospital admissions and outpatient visits in women highlights its potential as a preferential treatment option in this demographic."

Clinical • Gastrointestinal Disorder

Current and emerging pharmacotherapy for the treatment of gastroparesis. (PubMed, Expert Opin Pharmacother) - "The expansion of the research involving dopamine receptor antagonists and delving into alternative mechanisms of alleviating gastroparesis symptoms have been crucial in the landscape of gastroparesis. This is especially true as our knowledge of gastroparesis has proved that simply improving gastric emptying does not necessarily translate to clinical improvement."

Journal • Review • Gastrointestinal Disorder • Pain

Metoclopramide Nasal Spray in Women with Symptomatic Diabetic Gastroparesis: A Randomized, Double-blind, Placebo-controlled Phase 3 Study. (PubMed, Clin Gastroenterol Hepatol) - P3 | "Although the primary endpoint was not met using all enrolled patients, treatment with MNS provided significant relief for women with moderate to severe diabetic gastroparesis symptoms. MNS was well tolerated and demonstrated a similar safety profile to placebo."

Clinical • Journal • P3 data • Diabetes • Gastrointestinal Disorder • Pain

Superiority of Nasal Spray Compared to Orally Administered Metoclopramide in Reducing Healthcare Costs in Treating Diabetic Gastroparesis Patients (ACG 2023) - "Nasal metoclopramide (NMCP) was approved in 2020 for acute and recurrent DGP... 45 NMCP patients were matched to 180 OMCP patients across demographic and disease severity, with standardized mean differences <0.10. NMCP-treated patients incurred lower cost across care sites: IH = -$10,021 (95%CI: -17,666, -2,376; p-value=.01), ED = -$926 (-1,371, -481; p-value< .001), HO= -$3,247 (-5,428, -1,066; p-value=.004), and LHT = -$472 (-846, -98; p-value =.014). Total medical cost (sum of all sites) was $16,808 (8,196, 25,420; p-value< .001) lower in the NMCP cohort."

Clinical • Head-to-Head • HEOR • Diabetes • Gastrointestinal Disorder • Metabolic Disorders

Use of Real-World Data for Hard-to-Identify Patient Population: Methodology and a Case Study (ISPOR 2023) - "We sought to identify whether tokenization and matching between SP data and administrative claims data was feasible and representative for a nasal formulation of metoclopramide ( nasal MCP) using the treatment of for diabetic gastroparesis (DGP)... Identif ication of patients outside the routine healthcare sources is important to understand patient journeys , HCRU and experiences with healthcare settings , and decisions concerning new treatment s; this particularly becomes more imperative for hard-to-find patients such as DGP treated with nasal MCP . The c omprehensive , population-level information on health, medical, and HCRU derived from RWD can help inform healthcare decision - making ."

Clinical • Real-world • Real-world evidence • Gastrointestinal Disorder • Psychiatry

REDUCING REAL-WORLD HEALTHCARE RESOURCE UTILIZATION FOR PATIENTS WITH DIABETIC GASTROPARESIS (DGP) TREATED WITH METOCLOPRAMIDE NASAL SPRAY VERSUS ORAL METOCLOPRAMIDE (DDW 2023) - "Patients treated with NMCP had a significantly lower all-cause PO, ED, and HO visits. Similarly, DGP symptom-related HRU was significantly lower for NMCP patients across all settings (except for HO) including IH. Keywords: gastroparesis, metoclopramide, nasal, oral, healthcare resource utilization"

Clinical • HEOR • Real-world • Real-world evidence • Gastrointestinal Disorder

USE OF MACHINE LEARNING TO IDENTIFY GASTROPARESIS PATIENT APPROPRIATE FOR NASAL SPRAY METOCLOPRAMIDE (DDW 2023) - "Diabetes is present in 51.5%. ML allows us to efficiently identify patients with similar profiles and clinical journey, who could benefit from initiation of NMCP."

Clinical • Machine learning • Diabetes • Gastrointestinal Disorder • Metabolic Disorders

Evoke Pharma’s Real-World Healthcare Utilization Data Comparing GIMOTI to Oral Metoclopramide to Be Presented at Digestive Disease Week (DDW) 2023 (GlobeNewswire) - "Evoke Pharma, Inc...announced that the abstract entitled 'Reducing Real-World Healthcare Resource Utilization For Patients With Diabetic Gastroparesis (DGP) Treated with Metoclopramide Nasal Spray Versus Oral Metoclopramide' will be presented at Digestive Disease Week (DDW) 2023 taking place from May 6-9, 2023 at the McCormick Place, Chicago...An additional poster presentation entitled 'use of Machine Learning to Identify Gastroparesis Patient Suitable for Nasal Spray Metoclopramide' will be presented by Pierantonio Russo, MD, Chief Medical Officer of EVERSANA. This study used large claims databases and clinical features of GIMOTI-prescribed patients to predictively model patients in the US who might be appropriate for GIMOTI based on having similar clinical features. In addition, Evoke Pharma will showcase their GIMOTI nasal spray and supporting educational materials at DDW booth #3334. Evoke encourages all attendees to visit their booth for additional..."

Clinical data • Gastroenterology

New GIMOTI Patent Listed in FDA Orange Book (GlobeNewswire) - "Evoke Pharma, Inc...announced that its recently issued U.S. patent related to GIMOTI, No. 11,628,150 is now listed in the U.S. Food and Drug Administration (FDA) publication, 'Approved Drug Products with Therapeutic Equivalence Evaluations', commonly known as the 'Orange Book'...The patent titled 'Nasal Formulations of Metoclopramide' covers a collection of nasal solutions of metoclopramide and its characteristics when formulated. This new patent is now listed in the FDA’s Orange Book and carries a patent term to 2029. The listing of the patent in the Orange Book adds additional patent protection for GIMOTI beyond the prior two listed patents."

Patent • Gastroenterology

United States Patent and Trademark Office (USPTO) Grants Evoke Pharma a Formulation Patent Covering GIMOTI (GlobeNewswire) - "Evoke Pharma, Inc....announced that the United States Patent and Trademark Office (USPTO) issued US patent No. 11,628,150 under the title 'Nasal Formulations of Metoclopramide'...This patent expires in 2029 and covers the nasal solution of metoclopramide and its characteristics when formulated. The patent augments Evoke’s existing patent portfolio, which includes U.S. Food and Drug Administration (FDA) Orange Book-listed patents and other patents in the EU, Japan, Canada, and Mexico. The Company will seek to list this patent in the FDA Orange-Book in the near term."

FDA event • Patent • Gastroenterology

Real-world healthcare resource utilization of patients treated with metoclopramide nasalspray for diabetic gastroparesis (AMCP 2023) - "Patients using nasal mcp demonstrated a decline in all-cause and DGP HRU pre- versus post-treatment for office, ED, inpatient and outpatient visits across all settings for the 6-month intervals following initiation of treatment with significant reductions in DGP-related PO, and HO and a numerical improvement for ED. Similar results are observed in all-cause HRU."

Clinical • HEOR • Real-world • Real-world evidence • Gastrointestinal Disorder

"$EVOK Evoke Announces Teva Ends Pursuit of Paragraph IV ANDA Against Gimoti https://t.co/kDCeZD2F3I" (@stock_titan)

ANDA

"$EVOK GIMOTI Receives Nomination for 2022 Healio Industry Breakthrough Award https://t.co/K42NL6US0u" (@stock_titan)

"$EVOK Evoke Pharma Announces Approval of GIMOTI® to Florida State Medicaid Program https://t.co/vIm0wGG3CX" (@stock_titan)

Medicaid • Reimbursement

20236 - Emerging Strategies in Diabetic Gastroparesis Care: Rethinking the Status Quo (DDW 2022) - "Explore the burden of DGP, unmet treatment need and the role of GIMOTI nasal spray in the treatment paradigm. Discuss potential benefits of the nasal route of administration and the challenge of treating DGP patients with oral meds. Supported by Evoke Pharma"

Gastrointestinal Disorder

"$EVOK Evoke Pharma Granted FDA Market Exclusivity for GIMOTI® https://t.co/6eu3X6LAUM" (@stock_titan)

"$EVOK Evoke Pharma Announces Approval of GIMOTI® to the Texas Medicaid Preferred Drug List https://t.co/uUeswcszPk" (@stock_titan)

Medicaid • Reimbursement

"$EVOK Evoke Pharma and EVERSANA Extend Commercialization Partnership to Further Support GIMOTI https://t.co/B4UAyCFE27" (@stock_titan)

Licensing / partnership

"In the meantime, check out all our breakthrough nominees: Zeposia (Ozanimod, @ScienceAtBMS), Gimoti (metoclopramide, Evoke Pharma), SuTab (sulfate prep, Sebela Pharmaceuticals), @Cologuard and Budesonide (@TakedaPharma)" (@HealioGastro)

Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis. (PubMed, JAMA) - No abstract available

Journal • Gastrointestinal Disorder

"$EVOK Evoke Pharma and EVERSANA Launch Social Media Campaign for Gimoti® Nasal Spray https://t.co/I8KrboVj8V" (@stock_titan)