Claims for Patent: 12,263,162

Summary for Patent: 12,263,162

Title:	Compositions, devices, and methods for treating or preventing headaches
Abstract:	Disclosed herein are pharmaceutical compositions, devices, their combinations, and their uses thereof for example in treating or preventing headaches.
Inventor(s):	John KOLLINS, Fumiyoshi IWASHIMA, Detlef Albrecht, Robert David Schultz
Assignee:	Satsuma Pharmaceuticals Inc
Application Number:	US16/933,560
Patent Claims:	1. A method for treating or preventing a headache, comprising administering to a human subject a powdery pharmaceutical composition that comprises 5 mg to about 7 mg of dihydroergotamine mesylate, and an excipient; wherein said excipient comprises about 18 mg to about 19 mg of microcrystalline cellulose, and hydroxypropyl methylcellulose. 2. The method of claim 1, wherein the method does not cause clinically significant changes in nasal mucosa integrity, nasal irritation, or a combination thereof, wherein said clinically significant changes in nasal mucosa integrity, nasal irritation, or a combination thereof may be measured by a mean Visual Analog Scale score, wherein said mean Visual Analog Scale score is less than about 20 if measured within 24 hours following said administration, wherein said Visual Analog Scale score is measured in a scale of 0 (none) to 100 (worst imaginable) based on each of the following nasal symptoms: nasal discomfort, nasal burning, nasal itching, nasal pain, nasal blockage or obstruction, abnormal taste, runny nose, and sneezing. 3. The method of claim 2, wherein said Visual Analog Scale score is measured at about 4 hours following said administration. 4. The method of claim 2, wherein said Visual Analog Scale score is measured at about 1 hour following said administration. 5. The method of claim 2, wherein said Visual Analog Scale score is measured at about 15 minutes following said administration. 6. The method of claim 2, wherein said Visual Analog Scale score is measured at about 5 minutes following said administration. 7. The method of claim 2, wherein said Visual Analog Scale score is less than about 10. 8. The method of claim 2, wherein said Visual Analog Scale score is less than about 5. 9. The method of claim 2, wherein said Visual Analog Scale score is about 0. 10. The method of claim 1, wherein said administration comprises delivering two or more unit doses of said powdery pharmaceutical composition in two or more devices to said human subject. 11. The method of claim 10, wherein said two or more unit doses are administered successively to said human subject. 12. The method of claim 10, wherein said two or more unit doses are administered sequentially by about 2 hours or longer apart. 13. The method of claim 1, wherein said administration is intranasal. 14. The method of claim 1, wherein said headache is a migraine headache. 15. The method of claim 1, wherein said headache comprises a migraine headache with aura, a migraine headache without aura, cluster headache, post-traumatic headache, hemiplegic migraine, basilar migraine, episodic migraine, chronic migraine, refractory migraine, migraine attack when treatment is initiated at least 1-24 hours after an onset of attack, migraine attack when treatment is initiated at the earliest premonitory sign or symptom, pediatric migraine, status migraine, chronic daily headache, a migraine attack with allodynia, menstrually-associated migraine, menstrual migraine, migraine-upon-awakening, rapid-onset migraine, or any combination thereof. 16. The method of claim 1, wherein said administering to a human subject comprises administering two or more unit doses of the powdery pharmaceutical composition sequentially by about 1 or about 2 hours apart, in two or more devices. 17. The method of claim 16, wherein said two or more unit doses are administered sequentially by about 2 hours apart. 18. The method of claim 16, wherein said administration is intranasal. 19. The method of claim 16, wherein said headache is a migraine headache. 20. The method of claim 16, wherein said headache comprises a migraine headache with aura, a migraine headache without aura, cluster headache, post-traumatic headache, hemiplegic migraine, basilar migraine, episodic migraine, chronic migraine, refractory migraine, migraine attack when treatment is initiated at least 1-24 hours after an onset of attack, migraine attack when treatment is initiated at the earliest premonitory sign or symptom, pediatric migraine, status migraine, chronic daily headache, a migraine attack with allodynia, menstrually-associated migraine, menstrual migraine, migraine-upon-awakening, rapid-onset migraine, or any combination thereof. 21. The method of claim 16, wherein each of said two or more devices comprises a poppet valve and a retainer, wherein the retainer is hollow and holds the poppet valve. 22. The method of claim 2, wherein said clinically significant changes in nasal mucosa integrity, nasal irritation, or a combination thereof, is measured using an assessment conducted one or more times. 23. The method of claim 22, wherein said assessment is an objective assessment. 24. The method of claim 22, wherein said clinically significant changes in nasal mucosa integrity, nasal irritation, or a combination thereof, is measured by a subjective assessment. 25. The method of claim 1, wherein the dihydroergotamine mesylate is amorphous dihydroergotamine mesylate.