We claim,
1. A pharmaceutical nasal dosage form, comprising: dihydroergotamine or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient, for treating migraine with or without aura in human subjects, wherein said dosage form is provided in a pre-primed nasal device and said dosage form requires less than 15 minutes to administer an effective dose of dihydroergotamine.
2. The nasal dosage form of claim 1, wherein said dosage form provided in the pre-primed nasal device requires less than four sprays to administer said effective dose of dihydroergotamine.
3. The nasal dosage form of claim 1, wherein said effective dose is from about 0.5 mg to about 2.0 mg.
4. The nasal dosage form of claim 1, wherein said dosage form further comprises one or more stabilizers.
5. The nasal dosage form of claim 4, wherein said stabilizers are present in an amount of from about 0.01% w/w to about 10% w/w.
6. The nasal dosage form of claim 4, wherein said stabilizers are selected from the group of stabilizers consisting of: citric acid, tartaric acid, ascorbic acid, acetic acid, formic acid, methanoic acid, fumaric acid, propionic acid, butanoic acid, ethanoic acid, benzoic acid, butyric acid, malic acid, propionic acid, epoxysuccinic acid, muconic acid, furanacrylic acid, citramalic acid, capric acid, stearic acid, caproic acid, malonic acid, succinic acid, diethylacetic acid, methylbutyric acid hydrochloric acid, hydrobromic acid, phosphoric acid, nitric acid, sulfuric acid, butylated hydroxyanisole, butylated hydroxy toluene, monothioglycerol, propyl gallate, sodium ascorbate, sodium bisulfite, sodium metabisulfite, sodium citrate, potassium metabisulfite, potassium sulfite, ammonium acetate, sodium sulfite, tocopherol succinate D-a-tocopheryl polyethylene glycol succinate, D-a-tocopheryl polyethylene glycol 1000 succinate, D-a-tocopherol polyethylene glycol 2000 succinate, and combinations thereof.
7. The nasal dosage form of claim 6, wherein said stabilizers are selected from the group of stabilizers consisting of: citric acid, ascorbic acid, acetic acid, sodium citrate, ammonium acetate, and combinations thereof.
8. The nasal dosage form of claim 6, wherein said stabilizers are selected from the group of stabilizers consisting of: tocopherol succinate D-a-tocopheryl polyethylene glycol succinate, D-a-tocopheryl polyethylene glycol 1000 succinate, D-a-tocopherol polyethylene glycol 2000 succinate, and combinations thereof.

9. The nasal dosage form of claim 1, wherein said dosage form does not show any precipitation upon storage at 2°C to 8°C, 25°C, 40°C, or 45°C for at least 7 days.
10. The nasal dosage form of claim 1, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher dC/dT value compared to a commercially-available 2 mg dihydroergotamine nasal dosage form, and said dC/dT value is measured in a single dose human pharmacokinetic study in a time period of Tomin to
1 15mins.
11. The nasal dosage form of claim 10, wherein said dosage form upon intranasal administration to human subjects provides a dC/dT value of at least about 1000 (pg/mL)/hr in a time period of Tomin to T 15mins.
12. The nasal dosage form of claim 1, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV%) of Cmax compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
13. The nasal dosage form of claim 1, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV%) of AUC(o-t), AUC(o-oo), or AUC(o-2hr) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
14. The nasal dosage form of claim 1, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher AUQo-t), AUC(o-°o), or AUQo-2) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
15. A pharmaceutical nasal dosage form, comprising: dihydroergotamine or a pharmaceutically acceptable salt thereof, and sodium citrate, citric acid, or combinations thereof, for treating migraine with or without aura in human subjects, wherein said dosage form is provided in a pre-primed nasal device and said dosage form requires less than 15 minutes to administer an effective dose of dihydroergotamine.
16. The nasal dosage form of claim 15, wherein said dosage form provided in the pre-primed nasal device requires less than four sprays to administer said effective dose of dihydroergotamine.
17. The nasal dosage form of claim 15, wherein said effective dose is from about 0.5 mg to about 2.0 mg.
18. The nasal dosage form of claim 15, wherein said dosage form comprises dihydroergotamine and sodium citrate in a weight ratio of from about 1.0: 40.0 to about 40.0: 1.0.
19. The nasal dosage form of claim 15, wherein said dosage form comprises dihydroergotamine and citric acid in a weight ratio of from about 1.0: 40.0 to about 40.0: 1.0.

20. The nasal dosage form of claim 15, wherein said dosage form does not show any precipitation upon storage at 2°C to 8°C, 25°C, 40°C, or 45°C for at least 7 days.
21. The nasal dosage form of claim 15, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher dC/dT value compared to a commercially-available 2 mg dihydroergotamine nasal dosage form, and said dC/dT value is measured in a single dose human pharmacokinetic study in a time period of Tomin to T 15mins.
22. The nasal dosage form of claim 21, wherein said dosage form upon intranasal administration to human subjects provides a dC/dT value of at least about 1000 (pg/mL)/hr in a time period of Tomin to T 15mins.
23. The nasal dosage form of claim 15, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV%) of Cmax compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
24. The nasal dosage form of claim 15, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV%) of AUC(o-t), AUC(o-°o), or AUC(o-2hr) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
25. The nasal dosage form of claim 15, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher AUQo-t), AUC(o-oo), or AUC(o-2) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
26. A pharmaceutical nasal dosage form, comprising: dihydroergotamine or a pharmaceutically acceptable salt thereof; and ammonium acetate, acetic acid, or combinations thereof, for treating migraine with or without aura in human subjects, wherein said dosage form is provided in a pre-primed nasal device and said dosage form requires less than 15 minutes to administer an effective dose of dihydroergotamine.
27. The nasal dosage form of claim 26, wherein said dosage form requires less than four sprays to administer said effective dose of dihydroergotamine.
28. The nasal dosage form of claim 26, wherein said effective dose is from about 0.5 mg to about 2.0 mg.
29. The nasal dosage form of claim 26, wherein said effective dose is less than about 2 mg of dihydroergotamine.

30. The nasal dosage form of claim 26, wherein said dosage form comprises dihydroergotamine and ammonium acetate in a weight ratio of from about 1.0: 40.0 to about 40.0: 1.0.
31. The nasal dosage form of claim 26, wherein said dosage form comprises dihydroergotamine and acetic acid in a weight ratio of from about 1.0: 40.0 to about 40.0: 1.0.
32. The nasal dosage form of claim 26, wherein said dosage form does not show any precipitation upon storage at 2°C to 8°C, 25°C, 40°C, or 45°C for at least 7 days.
33. The nasal dosage form of claim 26, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher dC/dT value compared to a commercially-available 2 mg dihydroergotamine nasal dosage form, and said dC/dT value is measured in a single dose human pharmacokinetic study in a time period of Tomin to T 15mins.
34. The nasal dosage form of claim 33, wherein said dosage form upon intranasal administration to human subjects provides a dC/dT value of at least about 1000 (pg/mL)/hr in a time period of Tomin to T 15mins.
35. The nasal dosage form of claim 26, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV%) of Cmax compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
36. The nasal dosage form of claim 26, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV%) of AUC(o-t), AUC(o-oo), or AUC(o-2hr) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
37. The nasal dosage form of claim 26, wherein said dosage form upon intranasal administration to human subj ects provides at least about 10 percent higher AUQo-t), AUQo-oo), or AUC(o-2) compared to commercially available 2 mg of dihydroergotamine nasal dosage form.
38. A pharmaceutical nasal dosage form, comprising: dihydroergotamine or a pharmaceutically acceptable salt thereof, and ascorbic acid, for treating migraine with or without aura in human subjects, wherein said dosage form is provided in a pre-primed nasal device and said dosage form requires less than 15 minutes to administer an effective dose of dihydroergotamine.
39. The nasal dosage form of claim 38, wherein said dosage form requires less than four sprays to administer said effective dose of dihydroergotamine.

40. The nasal dosage form of claim 38, wherein said effective dose is from about 0.5 mg to about 2.0 mg.
41. The nasal dosage form of claim 38, wherein said effective dose is less than about 2 mg of dihydroergotamine.
42. The nasal dosage form of claim 38, wherein said dosage form comprises dihydroergotamine and ascorbic acid in a weight ratio of from about 1.0: 40.0 to about 40.0: 1.0.
43. The nasal dosage form of claim 38, wherein said dosage form does not show any precipitation upon storage at 2°C to 8°C, 25°C, 40°C, or 45°C for at least 7 days.
44. The nasal dosage form of claim 38, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher dC/dT value compared to a commercially-available 2 mg dihydroergotamine nasal dosage form, and said dC/dT value is measured in a single dose human pharmacokinetic study in a time period of Tomin to T 15mins.
45. The nasal dosage form of claim 44, wherein said dosage form upon intranasal administration to human subjects provides a dC/dT value of at least about 1000 (pg/mL)/hr in a time period of Tomin to T 15mins.

46. The nasal dosage form of claim 38, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV %) of Cmax compared to a commercially available 2 mg dihydroergotamine nasal dosage form.
47. The nasal dosage form of claim 38, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV %) of AUQo-t), AUQo-oo), or AUC(o-2hr) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
48. The nasal dosage form of claim 38, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher AUQo-t), AUC(o-oo), or AUC(o-2) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
49. A pharmaceutical nasal dosage form, comprising: an aqueous solution of dihydroergotamine or a pharmaceutically acceptable salt thereof, and vitamin E TPGS, for treating migraine with or without aura in human subjects, wherein said dosage form is provided in a a pre-primed nasal device and said dosage form requires less than 15 minutes to administer an effective dose of dihydroergotamine.

50. The nasal dosage form of claim 49, wherein said dosage form requires less than four sprays to administer said effective dose of dihydroergotamine.
51. The nasal dosage form of claim 49, wherein said effective dose is from about 0.5 mg to about 2.0 mg.
52. The nasal dosage form of claim 49, wherein said dosage form comprises dihydroergotamine and vitamin E TPGS in a weight ratio of from about 1.0: 40.0 to about 40.0: 1.0.
53. The nasal dosage form of claim 49, wherein said dosage form does not show any
precipitation upon storage at 2°C to 8°C, 25°C, 40°C, or 45°C for at least 7 days.
54. The nasal dosage form of claim 49, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher dC/dT value compared to a commercially-available 2 mg dihydroergotamine nasal dosage form, and said dC/dT value is measured in a single dose human pharmacokinetic study in a time period of Tomin to T 15mins.
55. The nasal dosage form of claim 54, wherein said dosage form upon intranasal administration to human subjects provides a dC/dT value of at least about 1000 (pg/mL)/hr in a time period of Tomin to T 15mins.
56. The nasal dosage form of claim 49, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV %) of Cmax compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
57. The nasal dosage form of claim 49, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10% reduction in coefficient of variance (CV %) of AUQo-t), AUQo-oo), or AUC(o-2hr) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.
58. The nasal dosage form of claim 49, wherein said dosage form upon intranasal administration to human subjects provides at least about a 10 percent higher AUQo-t), AUC(o-oo), or AUC(o-2) compared to a commercially-available 2 mg dihydroergotamine nasal dosage form.