METHOD OF THERAPEUTIC ADMINISTRATION OF DHE TO ENABLE RAPID RELIEF OF MIGRAINE WHILE MINIMIZING SIDE EFFECT PROFILE
1 Assignment
0 Petitions
Accused Products
Abstract
Pharmaceutical compositions containing dihydroergotamine (DHE) and methods in which DHE is administered to patients for treatment of migraine without side effects or adverse effects are disclosed. Methods for rapid treatment of migraine with DHE are disclosed comprising: dampening the peak plasma concentration (Cmax) and slightly delaying the peak such as to avoid activating the dopaminergic and adrenergic receptors, while achieving sufficient active binding to the serotonin receptors to provide relief from migraine symptoms within a timeframe that permits rapid resolution of migraine symptoms. Inhaler devices suitable for the methods are disclosed. Kits for practicing the methods of invention are disclosed.
-
Citations
82 Claims
-
1-52. -52. (canceled)
-
53. A method comprising:
-
administering a total dose of dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof to a human; wherein the dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof is administered at a rate such that a mean peak plasma concentration (Cmax) of dihydroergotamine thereof is less than 60,000 pg/ml, and a mean time to Cmax (Tmax) of dihydroergotamine is less than 20 minutes; and wherein the total dose of dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof ranges from 0.1 to 10 mg. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67)
-
-
68. A method comprising:
-
administering a unit dose of dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof to a human; wherein the dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof is administered at a rate such that a mean time to Cmax (Tmax) of dihydroergotamine is less than 20 minutes, and a mean area under a curve of a concentration of dihydroergotamine in systemic circulation versus time (AUC) of the dihydroergotamine delivered is within 75% of a comparable intravenous (IV) delivered dose; and wherein the unit dose of dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof is less than 2.0 mg.
-
-
69. A device comprising:
-
an inhaler; and one or more doses of a formulation comprising dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof to a human; wherein the inhaler is configured to administer each unit dose at a rate such that a mean peak plasma concentration (Cmax) of dihydroergotamine is less than 60,000 pg/ml, and a mean time to Cmax (Tmax) of dihydroergotamine is less than 20 minutes. - View Dependent Claims (70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82)
-
Specification