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What is Gastroparesis?

Gastroparesis is a condition of delayed gastric emptying in the absence of mechanical obstruction. It occurs more frequently in individuals with diabetes, but also is observed in patients with prior gastric surgery, a preceding infectious illness, pseudo-obstruction, collagen vascular disorders and anorexia nervosa. According to the American Motility Society Task Force on Gastroparesis, the prevalence is as high as 4% to 6% of the United States population. Common symptoms include nausea, vomiting, abdominal pain, bloating and early satiety. The disorder can cause considerable pain and discomfort and can lead to poor nutrition, impaired glycemic control and diminished quality of life. According to a 2008 study published in the American Journal of Gastroenterology, it is estimated that hospitalization costs associated with gastroparesis exceed $3.5 billion annually.

Homeevokepharma2020-11-19T22:38:12+00:00

Gastroparesis Symptoms: Unpredictable & Difficult To Treat

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
Symptoms characteristic of a disease flare:
- Nausea
- Bloating
- Upper Abdominal Pain
- Prolonged Fullness
- Early Satiety
- Vomiting

16 Million Patients with Gastroparesis Symptoms

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

Current Oral Treatment Options Lack Predictable Delivery

Motility & Symptoms

Metoclopramide (1^st 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

Formulated to Provide Systemic Absorption Regardless of Gastric Emptying Delays and Gastroparesis Disease Flares