NEUROTOXIN COMPOSITIONS FOR USE IN TREATING GASTROPARESIS

1 ) A method of treating gastroparesis comprising the steps of;

administering a first botulinum toxin into the pyloric sphincter; and

administering a second botulinum toxin into the fundus and proximal corpus;

thereby reducing the severity of at least one symptom of the disorder.

2 ) The method of claim 1 , wherein at least one of said first and second botulinum toxins comprise botulinum toxin type A.

3 ) The method of claim 2 , wherein at least one of said first and second botulinum toxins comprise native immunotype A.

4 ) The method of claim 1 , wherein at least one of said first and second botulinum toxins comprise botulinum toxin type B, C, E, or F.

5 ) The method of claim 4 , wherein at least one of said first and second botulinum toxins comprise botulinum toxin type B.

6 ) The method of claim 4 , wherein at least one of said first and second botulinum toxins comprise botulinum toxin type C.

7 ) The method of claim 4 , wherein at least one of said first and second botulinum toxins comprise botulinum toxin type E.

8 ) The method of claim 4 , wherein at least one of said first and second botulinum toxins comprise botulinum toxin type F.

9 ) The method of claims 2 - 8 , wherein at least one of said first and second botulinum toxins are administered by injection.

10 ) The method of claim 9 , wherein said gastroparesis comprises idiopathic gastroparesis.

11 ) The method of claim 9 , wherein said gastroparesis comprises diabetic gastroparesis.

12 ) The method of claim 9 , wherein said treating comprises reducing a symptom of gastroparesis, said symptom comprising at least one of swollen stomach, gassiness, chronic abdominal pain or discomfort, episodic stomach swelling, stomach pain, early fullness, abdominal bloating, early satiety, post-prandial fullness, post-prandial satiety, nausea, vomiting, acid reflux, diarrhea, problems swallowing, and combinations thereof.

13 ) The method of claim 12 , wherein said symptom comprises abdominal pain.

14 ) The method of claim 12 , wherein said symptom comprises nausea.

15 ) The method of claim 12 , wherein said symptom comprises vomiting.

16 ) The method of claim 12 , wherein said symptom comprises diarrhea.

17 ) The method of claim 12 , wherein said symptom comprises acid reflux.

18 ) The method of claim 12 , wherein said symptom comprises swollen stomach.

19 ) The method of claim 1 , wherein said first botulinum toxin is administered in an amount of between 50 and 200 Units.

20 ) The method of claim 1 , wherein said first botulinum toxin is administered in an amount of between 75 and 150 Units.

21 ) The method of claim 1 , wherein said second botulinum toxin is administered in an amount of between 50 and 200 Units.

22 ) A method of treating gastroparesis comprising the steps of;

administering a first botulinum toxin into the pyloric sphincter; and

administering a second botulinum toxin into at least one of the pyloric antrum and the pyloric canal;

administering a third botulinum toxin into the fundus and proximal corpus, thereby reducing the severity of at least one symptom of the disorder.

23 ) The method of claim 22 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type A.

24 ) The method of claim 23 , wherein at least one of said first, second, and third botulinum toxins comprise native immunotype A.

25 ) The method of claim 22 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type B, C, E, or F.

26 ) The method of claim 25 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type B.

27 ) The method of claim 25 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type C.

28 ) The method of claim 25 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type E.

29 ) The method of claim 25 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type F.

30 ) The method of claim 23 , wherein at least one of said first, second, and third botulinum toxins are administered by injection.

31 ) The method of claim 30 , wherein said treating comprises reducing a symptom of gastroparesis, said symptom comprising at least one of swollen stomach, gassiness, chronic abdominal pain or discomfort, episodic stomach swelling, stomach pain, early fullness, abdominal bloating, early satiety, post-prandial fullness, post-prandial satiety, nausea, vomiting, acid reflux, diarrhea, problems swallowing, and combinations thereof.

32 ) The method of claim 31 , wherein said symptom comprises abdominal pain.

33 ) The method of claim 31 , wherein said symptom comprises nausea.

34 ) The method of claim 31 , wherein said symptom comprises vomiting.

35 ) The method of claim 31 , wherein said symptom comprises diarrhea.

36 ) The method of claim 31 , wherein said symptom comprises acid reflux.

37 ) The method of claim 22 , wherein said first botulinum toxin is administered in an amount of between 50 and 200 Units.

38 ) The method of claim 22 , wherein said second botulinum toxin is administered in an amount of between 50 and 200 Units.

39 ) The method of claim 22 , wherein said third botulinum toxin is administered in an amount of between 50 and 200 Units.

40 ) A method of treating gastroparesis comprising the steps of;

administering a first botulinum toxin into the pyloric sphincter; and

administering a second botulinum toxin into at least one of the pyloric antrum and the pyloric canal;

administering a third botulinum toxin into the duodenum,

thereby reducing the severity of at least one symptom of the disorder.

41 ) The method of claim 40 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type A.

42 ) The method of claim 41 , wherein at least one of said first, second, and third botulinum toxins comprise native immunotype A.

43 ) The method of claim 40 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type B, C, E, or F.

44 ) The method of claim 43 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type B.

45 ) The method of claim 43 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type C.

46 ) The method of claim 43 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type E.

47 ) The method of claim 43 , wherein at least one of said first, second, and third botulinum toxins comprise botulinum toxin type F.

48 ) The method of claim 41 , wherein at least one of said first, second, and third botulinum toxins are administered by injection.

49 ) The method of claim 48 , wherein said treating comprises reducing a symptom of gastroparesis, said symptom comprising at least one of swollen stomach, gassiness, chronic abdominal pain or discomfort, episodic stomach swelling, stomach pain, early fullness, abdominal bloating, early satiety, post-prandial fullness, post-prandial satiety, nausea, vomiting, acid reflux, diarrhea, problems swallowing, and combinations thereof.

50 ) The method of claim 49 , wherein said symptom comprises abdominal pain.

51 ) The method of claim 49 , wherein said symptom comprises nausea.

52 ) The method of claim 49 , wherein said symptom comprises vomiting.

53 ) The method of claim 49 , wherein said symptom comprises diarrhea.

54 ) The method of claim 49 , wherein said symptom comprises acid reflux.

55 ) The method of claim 40 , wherein said first botulinum toxin is administered in an amount of between 50 and 200 Units.

56 ) The method of claim 40 , wherein said second botulinum toxin is administered in an amount of between 50 and 200 Units.

57 ) The method of claim 40 , wherein said third botulinum toxin is administered in an amount of between 50 and 200 Units.

58 ) A method of treating gastroparesis comprising the steps of;

a) administering a first botulinum toxin into the pyloric sphincter;

b) administering a second botulinum toxin into the pyloric canal;

c) administering a third botulinum toxin into the duodenum;

d) thereby reducing the severity of at least one symptom of the disorder.

59 ) The method of claim 58 , further comprising administering a fourth botulinum toxin into at least one of the fundus, proximal corpus, and pyloric antrum.

60 ) The method of claim 58 or 59 , wherein at least one of said first, second, third, and fourth botulinum toxins comprise botulinum toxin type A.

61 ) The method of claim 60 , wherein at least one of said first, second, third and fourth botulinum toxins comprise native immunotype A.

62 ) The method of claim 58 or 59 , wherein at least one of said first, second, third, and fourth botulinum toxins comprise botulinum toxin type B, C, E, or F.

63 ) The method of claim 62 , wherein at least one of said first, second, third, and fourth botulinum toxins comprise botulinum toxin type B.

64 ) The method of claim 62 , wherein at least one of said first, second, third, and fourth botulinum toxins comprise botulinum toxin type C.

65 ) The method of claim 62 , wherein at least one of said first, second, third, and fourth botulinum toxins comprise botulinum toxin type E.

66 ) The method of claim 62 , wherein at least one of said first, second, third, and fourth botulinum toxins comprise botulinum toxin type F.

67 ) The method of claim 58 or 59 , wherein at least one of said first, second, third, and fourth botulinum toxins are administered by injection.

68 ) The method of claim 58 or 59 , wherein said treating comprises reducing a symptom of gastroparesis, said symptom comprising at least one of swollen stomach, gassiness, chronic abdominal pain or discomfort, episodic stomach swelling, stomach pain, early fullness, abdominal bloating, early satiety, post-prandial fullness, post-prandial satiety, nausea, vomiting, acid reflux, diarrhea, problems swallowing, and combinations thereof.

69 ) The method of claim 68 , wherein said symptom comprises abdominal pain.

70 ) The method of claim 68 , wherein said symptom comprises nausea.

71 ) The method of claim 68 , wherein said symptom comprises vomiting.

72 ) The method of claim 68 , wherein said symptom comprises diarrhea.

73 ) The method of claim 68 , wherein said symptom comprises acid reflux.

74 ) The method of claim 68 , wherein said first botulinum toxin is administered in an amount of between 50 and 200 Units.

75 ) The method of claim 68 , wherein said second botulinum toxin is administered in an amount of between 50 and 200 Units.

76 ) The method of claim 68 , wherein said third botulinum toxin is administered in an amount of between 50 and 200 Units.

77 ) A method for comparing the efficacy and safety of two different Botulinum toxins, comprising:

measuring a reduction of a gastroparesis symptom of an individual resulting from administration of a first botulinum neurotoxin;

measuring a reduction of a gastroparesis symptom of an individual resulting from administration of a second botulinum neurotoxin; and

comparing the reduction in symptoms to determine a difference between the first botulinum neurotoxin and the second botulinum neurotoxin.

78 ) A method of demonstrating improvement in gastric emptying and reduction in pyloric hypertonicity demonstrated on antro-pyloric manometry in patients with gastroparesis.