Treatment of moderate and severe gastroparesis
Inventors
Carlson, Marilyn R. • D'Onofrio, Matthew J. • Gonyer, David A. • Alves, Wayne
Assignees
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Publication Number
US-11517545-B2
Publication Date
2022-12-06
Expiration Date
Abstract
Metoclopramide is administered for the treatment of moderate to severe gastroparesis, in some embodiments, severe gastroparesis.
Core Innovation
The invention relates to a method of treating symptoms associated with gastroparesis by selecting human patients diagnosed with gastroparesis and further selecting a treatment group with moderate to severe gastroparesis. The moderate-to-severe gastroparesis is defined by thresholds from the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) and/or Gastroparesis Symptom Assessment (GSA), and the selected patient for the treatment group has an mGCSI-DD score of 3 or greater and/or a GSA score of 2.7 or greater.
Only patients in the selected treatment group receive intranasal metoclopramide, or a pharmaceutically acceptable salt thereof, while patients who are not in the treatment group are administered standard of care. The intranasal metoclopramide is administered at 5 mg to 20 mg, 1 to 4 times per day, for a period of 1 to 12 weeks.
The treatment group approach is tied to targeting gastroparesis-associated symptoms associated with moderate-to-severe disease as defined by the mGCSI-DD or GSA. The symptoms addressed include nausea, retching, vomiting, bloating, early satiety, loss of appetite, stomach fullness/feeling full, stomach being visibly larger, and upper abdominal pain or upper abdominal discomfort.
Claims Coverage
The document portion provided identifies one independent claim. This independent claim covers an eligibility-selection framework using symptom-severity thresholds (mGCSI-DD and/or GSA), an intranasal metoclopramide dosing regimen limited to the selected treatment group, and standard of care for non-selected patients, for 1 to 12 weeks.
Selecting moderate-to-severe gastroparesis patients by mGCSI-DD and/or GSA thresholds
Selecting human patients diagnosed with gastroparesis, and selecting from the patients a treatment group consisting of moderate to severe gastroparesis defined by an mGCSI-DD score of 3 or greater and/or a GSA score of 2.7 or greater.
Intranasal metoclopramide dosing limited to the selected treatment group
Intranasally administering only to patients in the treatment group a dose of 5 mg to 20 mg of intranasal metoclopramide, or a pharmaceutically acceptable salt thereof, 1 to 4 times per day, for a period of 1 to 12 weeks.
Standard of care for non-selected gastroparesis patients
Administering to patients diagnosed with gastroparesis who are not in the treatment group a standard of care.
Across the provided portion, claim coverage centers on treating gastroparesis-associated symptoms by selecting moderate-to-severe patients using mGCSI-DD and/or GSA thresholds, administering intranasal metoclopramide only to that selected group under specified dosing and duration limits, and treating non-selected patients with standard of care.
Stated Advantages
Statistically significant efficacy versus placebo for patients with moderate-to-severe baseline symptoms, with improvements in GSA and nausea/upper abdominal pain as described.
Favorable safety profile as described, including no CNS effects and no tardive dyskinesia reported.
Documented Applications
Treating symptoms associated with gastroparesis by intranasal metoclopramide in a population selected as moderate to severe based on mGCSI-DD or GSA thresholds, with standard of care provided to non-selected patients.
Clinical evaluation in a multicenter randomized placebo-controlled study in adult women with diabetic gastroparesis and moderate-to-severe baseline symptoms, using endpoints including GSA and mGCSI-DD/GSA-related measures, as described.
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