METHOD OF THERAPEUTIC ADMINISTRATION OF DHE TO ENABLE RAPID RELIEF OF MIGRAINE WHILE MINIMIZING SIDE EFFECT PROFILE
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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.
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Citations
84 Claims
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1-52. -52. (canceled)
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53. A method comprising:
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administering 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 8-hydroxy dihydroergotamine is less than 10,000 pg/ml, and a mean time to Cmax (Tmax) of 8-hydroxy dihydroergotamine is less than 45 minutes. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68)
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69. A method comprising:
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administering 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 8-hydroxy dihydroergotamine is less than 10,000 pg/ml, and a mean time to Cmax (Tmax) of 8-hydroxy dihydroergotamine is less than 45 minutes; and wherein a total dose of the dihydroergotamine, or a complex, chelate, salt, hydrate, polymorph, or ion pair thereof that is administered ranges from 0.1 mg to 10.0 mg. - View Dependent Claims (70)
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71. A device comprising:
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an inhaler; and one or more unit 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 8-hydroxy dihydroergotamine is less than 10,000 pg/ml, and a mean time to Cmax (Tmax) of 8-hydroxy dihydroergotamine is less than 45 minutes. - View Dependent Claims (72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84)
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Specification