Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs
DC CAFCFirst Claim
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1. A method of treating a patient for migraine headache, comprising:
- (a) administering a 5-HT agonist to said patient, wherein said 5-HT agonist is a triptan; and
(b) administering a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) to said patient, wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours;
wherein;
(i) said 5-HT agonist and said LA-NSAID are concomitantly administered in unit dosage form; and
(ii) the respective amounts of said 5-HT agonist and said LA-NSAID administered to said patient are sufficient to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist.
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Abstract
The invention is directed to methods and compositions that can be used in the treatment of headaches. In particular, methods and compositions are described involving the combination of a long-acting NSAID and a 5-HT agonist. Included among the long-acting NSAIDs are cyclo-oxygenase-2 inhibitors.
159 Citations
32 Claims
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1. A method of treating a patient for migraine headache, comprising:
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(a) administering a 5-HT agonist to said patient, wherein said 5-HT agonist is a triptan; and
(b) administering a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) to said patient, wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours;
wherein;
(i) said 5-HT agonist and said LA-NSAID are concomitantly administered in unit dosage form; and
(ii) the respective amounts of said 5-HT agonist and said LA-NSAID administered to said patient are sufficient to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist. - View Dependent Claims (2, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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3. A pharmaceutical composition in unit dosage form, useful in treating a migraine headache patient, which comprises:
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(a) a 5-HT agonist, wherein said 5-HT agonist is a triptan; and
(b) a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID), wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours;
wherein the respective amounts of said 5-HT agonist and said LA-NSAID in said composition are effective, upon concomitant administration to said patient of one or more of said unit dosage forms of said composition, to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist.
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4. A therapeutic package for dispensing to, or for use in dispensing to, a migraine headache patient, which comprises:
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(a) one or more unit dosage forms, each unit dosage form comprising;
(i) a 5-HT agonist, wherein said 5-HT agonist is a triptan; and
(ii) a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID), wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours;
wherein the respective amounts of said 5-HT agonist and said LA-NSAID in said unit dosage f6 rms are effective, upon concomitant administration to said patient of one or more of said unit dosage forms, to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist; and (b) a finished pharmaceutical container therefore, said container containing said unit dosage form or unit dosage forms, and further comprising labeling directing the use of said package in the treatment of migraine headache.
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5. A method for producing longer lasting efficacy in a migraine headache patient which comprises:
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(a) administering a 5-HT agonist to said patient, wherein said 5-HT agonist is a triptan; and
(b) administering a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) to said patient, wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours;
wherein;
(i) said 5-HT agonist and said LA-NSAID are concomitantly administered in unit dosage form after the onset of symptoms associated with migraine headache; and
(ii) the respective amounts of said 5-HT agonist and said LA-NSAID administered to said patient are effective to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist.
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25. A pharmaceutical composition In unit dosage form, useful in treating a migraine headache patient, wherein the active agents in said pharmaceutical composition consist essentially of:
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(a) a 5-HT agonist, wherein said 5-HT agonist is a triptan; and
(b) a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID), wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours;
wherein the respective amounts of said 5-HT agonist and said LA-NSAID in said composition are effective, upon concomitant administration to said patient of one or more of said unit dosage forms of said composition, to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist. - View Dependent Claims (26, 27, 31, 32)
a) said pharmaceutical composition is suitable for oral administration;
b) said sumatriptan is present in an amount of between 25 and 100 mg; and
c) said naproxen is present in an amount of between 200 and 600 mg.
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31. A method of treating a patient for migraine headache, comprising administering the pharmaceutical composition of any one of claims 25-30 to said patient after the onset of symptoms associated with migraine headache.
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32. A therapeutic package for dispensing to, or for use in dispensing to, a migraine headache patient, which comprises:
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(a) the pharmaceutical composition in unit dosage form of any one of claims 25-30; and
(b) a finished pharmaceutical container therefore, said container containing said unit dosage form or unit dosage forms, and further comprising labeling directing the use of said pharmaceutical composition in the treatment of migraine headache.
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28. A pharmaceutical composition in unit dosage form, useful in treating a migraine headache patient, wherein the active agents in said pharmaceutical composition consist of:
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(a) a 5-HT agonist, wherein said 5-HT agonist is a triptan; and
(b) a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID), wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours;
wherein the respective amounts of said 5-HT agonist and said LA-NSAID in said composition are effective, upon concomitant administration to said patient of one or more of said unit dosage forms of said composition, to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist. - View Dependent Claims (29, 30)
a) said pharmaceutical composition is suitable for oral administration;
b) said sumatriptan is present in an amount of between 25 and 100 mg; and
c) said naproxen is present in an amount of between 200 and 600 mg.
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Specification