Claims for Patent: 12,377,064

Summary for Patent: 12,377,064

Title:	Treatment of moderate and severe gastroparesis
Abstract:	Metoclopramide is administered for the treatment of moderate to severe gastroparesis, in some embodiments, severe gastroparesis.
Inventor(s):	Marilyn R. Carlson, Matthew J. D'Onofrio, David A. Gonyer, Wayne Alves
Assignee:	Evoke Pharma Inc
Application Number:	US18/047,364
Patent Claims:	1. A method for treating symptoms associated with moderate to severe gastroparesis, the method comprising: intranasally administering to a patient having moderate to severe gastroparesis, 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, wherein a patient having moderate to severe gastroparesis is defined by the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) or Gastroparesis Symptom Assessment (GSA) as a patient having an mGCSI-DD score of 3 or greater and/or a GSA score of 2.7 or greater. 2. The method of claim 1, wherein the patient is receiving a standard of care for treating gastroparesis and/or has received a standard of care for treating gastroparesis, wherein the standard of care for treating gastroparesis is selected from the group consisting of oral or intravenous metoclopramide, pro-motility medications, antiemetic medications, pain medications, tricyclic antidepressants, specific meal plans or foods to consume/avoid, controlling glucose levels, correcting thyroid deficiencies, electrical pacing, and surgery. 3. The method of claim 1, wherein the intranasal metoclopramide administration treats one or more symptoms selected from the group consisting of nausea, bloating, early satiety, vomiting, feeling full, loss of appetite, stomach fullness, stomach being visibly larger, and upper abdominal discomfort. 4. The method of claim 1, wherein the patient has an mGCSI-DD score of approximately 4 or greater. 5. The method of claim 1, wherein the symptoms associated with gastroparesis comprise one or more of: (a) upper abdominal pain associated with female gastroparesis; (b) nausea associated with female gastroparesis; (c) bloating associated with female gastroparesis; (d) satiety associated with female gastroparesis; (e) vomiting associated with female gastroparesis; (f) retching associated with female gastroparesis; (g) feeling full associated with female gastroparesis; (h) loss of appetite associated with female gastroparesis; (i) stomach fullness associated with female gastroparesis; (j) stomach being visibly larger associated with female gastroparesis; and/or (k) upper abdominal discomfort associated with female gastroparesis. 6. The method of claim 1, wherein severity of the gastroparesis is assessed by the mGCSI-DD and/or by the GSA, and by one or more of questioning the patients regarding symptoms of gastroparesis by a Patient Reported Outcome (PRO) symptom measurement instrument, a gastrointestinal disorders-symptom severity index (PAGI-SYM), octanoic breath test, wireless capsule endoscopy, radioscintigraphy, ultrasonography, x-rays employing a radiopaque marker, a physician reported outcome measurement tool, and/or by physician clinical assessment. 7. The method of claim 6, wherein the radiopaque marker is barium. 8. The method of claim 6, wherein the PRO symptom measurement instrument comprises daily recordation of signs and symptoms. 9. The method of claim 6, wherein the PRO symptom measurement instrument comprises rating all signs and symptoms except vomiting by severity and rating vomiting by frequency rather than severity. 10. The method of claim 1, wherein a daily dose of metoclopramide is about 30 mg/day to about 80 mg/day. 11. The method of claim 10, wherein the patient is administered the dose 1, 2, 3, or 4 times per day. 12. The method of claim 11, wherein the dose has a volume of about 25 μL to 150 μL. 13. The method of claim 12, wherein the dose has a volume of about 70 μl. 14. The method of claim 1, wherein each dose comprises about 10 mg, about 14 mg, or about 15 mg. 15. The method of claim 14, wherein the patient is administered the dose 1, 2, 3, or 4 times per day. 16. The method of claim 15, wherein the dose has a volume of about 25 μL to 150 μL. 17. The method of claim 16, wherein the dose has a volume of about 70 μl.