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Publication Number
US-8440631-B2
Publication Date
2013-05-14
Expiration Date
Abstract
The present invention provides compositions and methods and for increasing the bioavailability of therapeutic agents in a subject, as well as compositions and methods for providing migraine pain relief. The compositions include at least one alkyl glycoside and at least one therapeutic agent, such as a 5-HT receptor agonist, wherein the alkylglycoside has an alkyl chain length from about 10 to about 16 carbon atoms.
Core Innovation
The invention provides a method of providing a 5-HT agonist to a subject by intranasally administering a composition comprising a 5-HT receptor agonist and an alkylsaccharide. The 5-HT agonist is sumatriptan, naratriptan, rizatriptan, eletriptan, frovatriptan, almotriptan, zolmitriptan, a salt thereof, or a combination thereof. The alkylsaccharide has an alkyl chain including between 10 to 16 carbons, and the composition exhibits a Tmax of 20 minutes or less.
The invention further relates to intranasal administration of such compositions to provide rapid onset of migraine pain relief. The method includes intranasally administering a composition containing a therapeutically effective amount of a 5-HT receptor agonist and an alkylsaccharide with an alkyl chain including between 10 to 16 carbons. In the subject, the composition exhibits a Tmax of 20 minutes or less, thereby providing rapid onset of migraine pain relief.
Additionally, the invention provides a method of reducing the incidence of migraine pain recurrence using the same intranasal composition framework. A therapeutically effective amount of a 5-HT receptor agonist is administered intranasally together with an alkylsaccharide having an alkyl chain including between 10 to 16 carbons. The composition provides a Tmax of 20 minutes or less, thereby providing a reduced incidence of migraine pain recurrence in the subject.
Claims Coverage
The independent claims are directed to intranasal methods using a 5-HT receptor agonist combined with an alkylsaccharide having an alkyl chain of 10 to 16 carbons, where the composition exhibits a Tmax of 20 minutes or less. Across the independent claims, the key inventive features are the intranasal administration of the specified 5-HT agonists with the defined alkylsaccharide chain-length and the Tmax performance condition, tied to migraine pain relief and migraine pain recurrence outcomes.
Intranasal 5-HT agonist with defined alkylsaccharide for Tmax ≤20 minutes
Intranasally administering to the subject a composition comprising a 5-HT receptor agonist selected from sumatriptan, naratriptan, rizatriptan, eletriptan, frovatriptan, almotriptan, zolmitriptan, a salt thereof, or combination thereof, and an alkylsaccharide having an alkyl chain including between 10 to 16 carbons, wherein the Tmax is 20 minutes or less.
Rapid onset migraine pain relief with Tmax ≤20 minutes after intranasal administration
Intranasally administering to the subject a composition comprising a therapeutically effective amount of a 5-HT receptor agonist selected from sumatriptan, naratriptan, rizatriptan, eletriptan, frovatriptan, almotriptan, zolmitriptan, a salt thereof, or combination thereof, and an alkylsaccharide having an alkyl chain including between 10 to 16 carbons, wherein the composition exhibits a Tmax of 20 minutes or less in the subject, thereby providing rapid onset of migraine pain relief.
Reduced incidence of migraine pain recurrence with Tmax ≤20 minutes after intranasal administration
Intranasally administering to the subject a composition comprising a therapeutically effective amount of a 5-HT receptor agonist selected from sumatriptan, naratriptan, rizatriptan, eletriptan, frovatriptan, almotriptan, zolmitriptan, a salt thereof, or combination thereof, and an alkylsaccharide having an alkyl chain including between 10 to 16 carbons, wherein the composition provides a Tmax of 20 minutes or less, thereby providing a reduced incidence of migraine pain recurrence in the subject.
Across the independent claims, the claim coverage centers on intranasal delivery of specified 5-HT receptor agonists together with an alkylsaccharide defined by an alkyl chain including between 10 to 16 carbons, with a performance condition of Tmax of 20 minutes or less. The independent claims tie this Tmax-limited composition to migraine pain relief and, separately, to reduced migraine pain recurrence.
Stated Advantages
Rapid onset of migraine pain relief.
Reduced incidence of migraine pain recurrence.
Documented Applications
Intranasal administration for migraine pain relief (rapid onset).
Intranasal administration for reduced incidence of migraine pain recurrence.
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