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Methods of treating headaches using 5-ht agonists in combination with long-acting nsaids

a technology of nsaids and agonists, which is applied in the field of treating patients with headaches, can solve the problems of rarely effective in providing complete relief symptoms, frequent recurrence of migraine symptoms, and headache symptoms, and achieves the effects of reducing migraine relapse, reducing migraine relapse, and being useful in migraine headache treatmen

Inactive Publication Date: 2011-11-10
POZEN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This combination therapy significantly reduces the frequency of headache relapse and provides sustained pain relief for up to 24 hours, offering greater efficacy than either drug alone with a reduced incidence of side effects.

Problems solved by technology

Unfortunately, it has been reported that many patients who experience migraine symptom relief within two hours after receiving a 5-HT agonist, experience migraine symptoms again within the next 24 hours.
However, these agents, when taken alone, are rarely effective in providing complete relief symptoms and, after initial remission, migraine symptoms often return.
The problems that occur with migraine headaches may also be present in other types of headache as well.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Evidence of Synergy With Respect to Relapse and Efficacy

[0063]A study was conducted to evaluate the combination of sumatriptan and the long acting NSAID naproxen in migraine patients known to have a high relapse rate, greater than 50% recurrence, when given sumatriptan alone. This was an open-label, randomized out-patient study in which 16 patients treated two successive migraine attacks with either sumatriptan alone (50 mg) or with sumatriptan (50 mg) plus naproxen as the sodium salt (500 mg). Headache pain was assessed by the patients on a 4-point scale (no pain, mild pain, moderate pain, or severe pain). Each patient was treated for two migraine attacks of moderate or severe intensity at baseline and pain scores were recorded every 30 minutes for the first two hours following dosing and at 3, 4, 6, 12 and 24 hours post-dose. “Relapse” was defined to occur in those patients who responded with an adequate reduction in headache pain (moderate or severe at baseline, reduced to no pai...

example 2

Evidence for Synergy in Rapid Pain Relief and for Other Migraine Symptoms—Additional Evidence With Respect to Sustained Pain Relief

[0069]In addition to the data presented above, data was obtained suggesting that triptans and long acting NSAIDs produce a surprising reduction in total, pain relief. In these experiments, a comparison was made between: patients administered triptan alone; patients administered NSAID alone; patients administered a combination of triptan and NSAID (“MT400”); and, in some cases, patients administered a placebo. The results demonstrate, inter alia, that when the combination is used, there is a dramatic increase in the percentage of patients that experience rapid, within two hours, pain relief. The results suggest that, in addition to the synergistic effects relating to relapse, there is also synergy with respect to both the short term and sustained pain response, parameters that are obviously of great importance to patients.

[0070]It was found that, at two h...

example 3

Effect of Combination Therapy on Secondary Symptoms of Migraine

[0073]As migraine is a pathological complex characterized by unilateral headache, often accompanied by associated symptoms of nausea, photophobia and phonophobia, efficacy against these other parameters is important in evaluating the efficacy of a drug candidate. The surprising benefits of MT 400 are further demonstrated in its impact on these associated symptoms. Analysis of secondary migraine symptom response is presented in Table 3. The percentage of MT 400 treated subjects with nausea at 2 hours was significantly lower than for placebo. The percentage of subjects with photophobia or phonophobia at 2 hours was significantly lower in the group treated with MT 400 than in either of the component groups or placebo. Only the combination provided relief against any or all secondary symptoms versus placebo to a statistically significant extent, and the combination was statistically significantly superior to individual compo...

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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-HT1B / 1D agonist.

Description

PRIORITY CLAIM[0001]The present application is a continuation of U.S. patent application Ser. No. 10 / 414,493, filed Apr. 16, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 09 / 559,753, filed Apr. 27, 2000 (now U.S. Pat. No. 6,586,458, issued Jul. 1, 2003), which is a continuation-in-part of U.S. patent application Ser. No. 09 / 151,912, filed Sep. 11, 1998(now U.S. Pat. No. 6,060,499, issued May 9, 2000), which is a division of U.S. patent application Ser. No. 08 / 907,826, filed Aug. 14, 1997 (now U.S. Pat. No. 5,872,145, issued Feb. 16, 1999) which claims priority to U.S. provisional patent application 60 / 024,129, filed on Aug. 16, 1996 (now abandoned), all of which are incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The invention is directed to methods of treating patients for headache by administering compositions containing a 5-HT1B / 1D agonist, preferably sumatriptan, and a long-acting NSAID, preferably napr...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/405A61P25/06A61P29/00A61K31/192A61K31/40A61K31/48A61K31/495A61K45/06
CPCA61K31/40A61K31/403A61K31/415A61K31/48A61K31/495A61K45/06A61K31/405A61K31/192A61K2300/00A61P25/06A61P29/00
Inventor PLACHETKA, JOHN R.
Owner POZEN INC
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