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Gastroparesis Symptoms: Unpredictable & Difficult To Treat

Gastroparesis Symptoms

Undissolved drug tablets in stomach

Simpson, S.E., Clinical Toxicology, 2011
  • Severe symptoms can cause malnutrition and require hospitalization

  • Absorption of oral medications is impaired due to delayed emptying of stomach contents

  • Vomiting further complicates effectiveness of oral medications

  • Undissolved drug tablets in stomachSymptoms characteristic of a disease flare:

    • Nausea
    • Bloating
    • Upper Abdominal Pain
    • Prolonged Fullness
    • Early Satiety
    • Vomiting

16 Million Patients with Gastroparesis Symptoms & Only 1 FDA Approved Drug

  • Estimated $3-4B prescription market

  • $3.5B in additional hospitalization costs in 2004

  • ~2-3M patients currently receive treatment

  • Under-diagnosed in part due to lack of awareness

  • Diabetes is number one known cause

  • Increasing prevalence due to growing diabetes rate

  • 80% of diabetic gastroparesis patients are women

 Million Patients

Current Oral Treatment Options Lack Predictable Delivery

Motility & Symptoms

  • Metoclopramide (1st line)

  • Domperidone (not FDA-approved)

Motility

  • Erythromycin (not FDA-approved)

Symptoms

  • Odansetron, Promethazine (nausea & vomiting)

  • PPI’s (upper abdominal pain)

  • Narcotics (upper abdominal pain)

 

Oral Treatments and Inadequate Response

  • Erratic absorption of oral drugs* (significant delay, dose dumping) or no absorption due to vomiting

  • Unpredictable efficacy and potential safety concerns

  • Lack of compliance due to nausea and other Gastroparesis symptoms

* Gastroparesis: Clinical Evaluation of Drugs for Treatment FDA Guidance for Industry. July 2015

GimotiTM Provides Predictable Absorption and Symptom Relief During A Flare
Regardless of Gastric Emptying Delays and Vomiting