Claims for Patent: 6,770,262

Summary for Patent: 6,770,262

Title:	Nasal administration of agents for the treatment of gastroparesis
Abstract:	The present invention is directed to a method for the treatment of gastroparesis by the use of metoclopramide nasal formulation.
Inventor(s):	Lehman; Laura S. (Palo Alto, CA), Tierney; David (Shrewsbury, NJ), Retzios; Anastassios D. (San Ramon, CA), Petrone; Michael (Voorhees, NJ), Young; David (Ellicott City, MD), Trapnell; Carol B. (Ellicott City, MD), Oliver; Ruth (Maidenhead, GB)
Assignee:	Questcor Pharmaceuticals, Inc. (Union City, CA)
Application Number:	09/821,139
Patent Claims:	1. A method for treating or reducing the symptoms of gastroparesis in a patient comprising: administering metoclopramide or a pharmaceutically acceptable salt thereof to a patient in need of gastroparesis treatment, wherein said metoclopramide is in a pharmaceutically acceptable nasal spray formulation and administered intranasally in a therapeutically effective amount at a daily dosage of about 40 mg/day to about 160 mg/day for about 2 weeks to about 8 weeks, so that one or more symptoms of gastroparesis is treated or reduced. 2. The method of claim 1 wherein said daily dosage is administered for about 5 weeks to about 8 weeks. 3. The method of claim 1 wherein said daily dosage is administered for about 6 weeks. 4. The method of claim 1 wherein said daily dosage is between about 40 mg/day and about 80 mg/day. 5. The method of claim 1 wherein said daily dosage is about 40 mg/day. 6. The method of claim 1 wherein said daily dosage is about 80 mg/day. 7. The method of claim 1 wherein said daily dosage is between about 2.5 mg/kg and about 2.5 mg/kg. 8. The method of claim 7, wherein said daily dosage is between about 0.6 mg/kg and about 1.2 mg/kg. 9. A method for treating or reducing the symptoms of gastroparesis in a patient comprising: administering metoclopramide or a pharmaceutically acceptable salt thereof to a patient in need of gastroparesis treatment, wherein said metoclopramide is in a pharmaceutically acceptable nasal formulation and administered intranasally as a spray or drops in a therapeutically effective amount at a daily dosage of between about 40 mg/day and about 160 mg/day, so that one or more symptoms of gastroparesis is treated or reduced. 10. The method of claim 9 wherein said deity dosage is between about 40 mg/day and about 80 mg/day. 11. The method of claim 9 wherein said daily dosage is about 40 mg/day. 12. The method of claim 9 wherein said daily dosage is about 80 mg/day. 13. The method of claim 9 wherein said daily dosage is between about 0.1 mg/kg and about 2.5 mg/kg. 14. The method of claim 13, wherein said daily dosage is between about 0.6 mg/kg and about 1.2 mg/kg. 15. The method of claim 1 or 9 wherein said daily dosage is divided into 3 or 4 equal doses and administered at equally spaced intervals within 24 hours. 16. The method of claim 15 wherein the doses are about 10 mg each. 17. The method of claim 15 wherein the doses are about 20 mg each. 18. The method of claim 1 or 9 wherein said daily dosage is divided into 3 or 4 equal doses and administered before meals. 19. The method of claim 18 wherein said doses are administered before meals and before bedtime. 20. The method of claim 18 wherein the doses are about 10 mg each when 4 doses are administered. 21. The method of claim 18 wherein the doses are about 20 mg each. 22. The method of claim 1 or 9 wherein the metoclopramide or pharmaceutically acceptable salt thereof is in an aqueous-based carrier. 23. The method of claim 1 or 9 wherein the metoclopramide or pharmaceutically acceptable salt thereof is in a sustained release formulation. 24. The method of claim 1 or 9 wherein the metoclopramide or pharmaceutically acceptable salt thereof is co-administered with one or more additional drugs. 25. The method of claim 1 or 9 wherein said dosage is administered for treating gastroparesis caused by any of: diabetes, a postviral syndrome, anorexia nervosa, surgery on the stomach or magus nerve, a medication, gastroesophageal reflux disease, smooth muscle disorder, a nervous system disease, or a metabolic disorder. 26. The method of claim 25 wherein said dosage is administered for treating gastroparesis caused by diabetes. 27. The method of claim 26 wherein said diabetes is selected from the group consisting of type 1 diabetes and type 2 diabetes. 28. The method of claim 25 wherein amid medication is selected from the group consisting of: anticholinergics, and narcotics which slow contractions in the intestine. 29. The method of claim 25 wherein said smooth muscle disorder is selected from the group consisting of: amyloidosis and scleroderma. 30. The method of claim 25 wherein said nervous system disease is selected from the group consisting of: abdominal migraine and Parkinson's disease. 31. The method of claim 25 wherein said metabolic disorder is hypothyroidism. 32. The method of claim 18 wherein said daily dosage is administered for about 2 to 6 weeks. 33. The method of claim 19 wherein said daily dosage is administered for about 2 to 6 weeks. 34. The method of claim 20 wherein said daily dosage is administered for about 2 to 6 weeks. 35. The method of claim 21 wherein said daily dosage is administered for about 2 to 6 weeks.