Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-06-14
2003-11-04
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S165000, C514S630000, C514S730000, C514S741000
Reexamination Certificate
active
06642243
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to compositions and methods used to alleviate the symptoms and pain associated with an acute migraine attack.
BACKGROUND OF THE INVENTION
An estimated 24 to 26 million Americans—about 18% of women and 6% of men—suffer from migraine pain and migraine-related symptoms. (Stewart W F, Lipton R B, Celentano D D, Reed M L. Prevalence of migraine headache in the United States: relation to age, income, race, and other sociodemographic factors. JAMA 1992; 267:64-69.) Attacks are common, with more than 32% of sufferers experiencing more than four episodes per month. (Rasmussen B K, Stewart W F. The Epidemiology of Migraine. In: Olesen J, Tfelt-Hansen P, Welch K M A, editors. The Headaches, second edition. New York, N.Y.: Raven Press; 2000; p. 227-233.)
Migraine, a heterogeneous disorder, produces a wide spectrum of pain and associated disabilities, both within and among individual sufferers. The spectrum includes mild pain and no disability in approximately 5-15% of migraine attacks, moderate to severe pain and disability in approximately 60-70% of attacks, and incapacitating pain and total disability in the remaining approximately 25-35% of attacks. (Stewart W F, Schecter A, Lipton R B. Migraine heterogeneity: disability, pain intensity, and attack frequency and duration. Neurology 1994; 44 Suppl 4:S24-S39 and Lipton R B, Stewart W F. Migraine in the United States: A review of epidemiology and health care use. Neurology 1993; 43 Suppl 3:S6-S10.)
Recent population-based epidemiological studies in the United States and elsewhere, have found that most people with migraines are not currently consulting a physician for their migraine attacks, and only about one-third have ever been diagnosed by a doctor. (Edmeads J, Findlay H, Tugwell P, Pryse-Phillips W, Nelson R F, Murray T J. Impact for migraine and tension-type headache on lifestyle, consulting behavior and medication use: a Canadian population survey. Can J Neurol Sci. 1993; 20:131-137; Lipton R B, Stewart W F. Medical consultation for migraine [abstract]. Neurology 1994; 44 Suppl 2:A199; and Rasmussen B K, Jensen R, Olesen J. Impact of migraine on sickness, absence and utilization of medical services: a Danish population study. J Epidemiol Community Health 1992; 46:443-446.) The overwhelming majority (95% of men and 97% of women) of migraineurs, i.e., individuals who suffer from migraines, used medication to assuage their pain, although only about 28% of the men and 40% of the women have ever used prescription medications. (Lipton R B, Stewart W F, Celentano D D, Reed M L. Undiagnosed migraine: A comparison of symptom-based and physician diagnosis. Arch Int Med 1992; 152:1273-1278; and Celentano D D, Stewart W F, Lipton R B, Reed M L. Medication use and disability among migraineurs: a national probability sample survey. Headache 1992; 32:223-228.) More than 90% of migraineurs use nonprescription medication for their migraines and the majority use nonprescription medications exclusively. (Stang P E, Osterhaus J T, Celentano D D. Migraine: patterns of healthcare use. Neurology 1994; 44 Suppl 4:S47-S55; and Edmeads J, Findlay H, Tugwell P, Pryse-Phillips W, Nelson R F, Murray T J. Impact for migraine and tension-type headache on lifestyle, consulting behavior and medication use: a Canadian population survey. Can J Neurol Sci. 1993; 20:131-137.)
Many migraine sufferers use single-agent nonprescription analgesics such as acetaminophen, or aspirin, or non-steroidal anti-inflammatory agents to treat their attacks. (Lipton R B, Newman L C, Solomon S. Over-the-counter medication and the treatment of migraine. Headache 1994; 34:547-548.) In other countries, a number of nonprescription drugs are specifically approved for migraine pain. (Lipton R B, Newman L C, Solomon S. Over-the-counter medication and the treatment of migraine. Headache 1994; 34:547-548.) The effectiveness of self-treatment of a migraine and the effectiveness of most such nonprescription drugs in relieving or aborting migraine pain and/or the characteristic symptoms of a migraine has not been adequately studied in well-controlled clinical trials. (Lipton R B, Newman L C, Solomon S. Over-the-counter medication and the treatment of migraine. Headache 1994; 34:547-548.) Acetaminophen, aspirin, and caffeine are approved for relief of nonspecific headaches and tension headaches (Migliardi J R, Armellino J J, Friedman M, Gillings D B, Beaver W T. Caffeine as an analgesic adjuvant in tension headache. Clin Pharmacol Ther 1994; 56:576-586), which are clinical and physiologically distinct from a migraine.
Caffeine is widely consumed and has also been indicated for use to treat asthma, drowsiness, fatigue, lumbar puncture headache, and neonatal apnea. [(Reents S. Clinical Pharmacology. Gold Standard Multimedia, Inc. (www.gsm.com) 1999. Available from URL:https://home.po.com.)] Caffeine is also an analgesic adjuvant for a variety of pain conditions and has been included in combination with other analgesics, ergot alkaloids, and barbiturates in prescription formulations for a migraine. (Laska E M, Sunshine A, Mueller F, Elvers W B, Siegel C, Rubin A. Caffeine as an analgesic adjuvant. JAMA 1984; 251:1711-1718; Olesen J. A review of current drugs for migraine. J Neurology 1991; 238 Suppl 1:S23-S27; Solomon G D. Therapeutic advances in migraine. J Clin Pharmacol 1993; 33:200-209; and Sawynok J. Pharmacological rationale for the clinical use of Caffeine. Drugs 1995; 49:37-50.) Caffeine itself may act to relieve a migraine. Caffeine has shown to reduce cerebral blood flow in humans and to be a nonselective adenosine receptor antagonist. Reduction of cerebral blood flow may be due to caffeine inhibition of the adenosine A2 receptor. (Sawynok J. Pharmacological rationale for the clinical use of Caffeine. Drugs 1995; 49:37-50.) A2 receptors are on cerebral vascular muscles, and act to cause vasodilation. Hence, their inhibition would have the effect of vasoconstriction similar to other medications used to abort the migraine headache.
Although the symptom pattern varies among migraine sufferers, the severity of migraine pain justifies a need for vigorous therapy in the great majority of cases. Traditional therapy, such as ergotamine, although effective during the prodrome phase of a migraine attack, is known to become progressively less effective if its administration is delayed. Ergotamine is frequently combined with caffeine, a known analgesic adjuvant, to facilitate absorption of the ergot alkaloid. (Schmidt R, Fanchamps A. Effect of Caffeine on intestinal absorption of ergotamine in man. Eur J Clin Pharmacol 1974; 57:213-216.) However, repeated dosing of ergotamine induces long-lasting and cumulative vasoconstriction, thereby requiring careful instructions and management of individuals who take oral preparations for migraine attack.
Because of the cumulative toxicity of ergotamine and its derivatives, safer therapeutics for the treatment and prophylaxis of migraines have been sought. Examples of such ergotamine alternatives are ergonovine, propranolol, and methysergide. Significant toxicity, however, also occurs in nearly 40% of the individuals who take these agents. A prescription anti-migraine medication that is an alternative to ergotamine and its derivatives is sumatriptan (or sumatriptan succinate), which is a selective 5-hydroxytryptamine. (Deleu D, Hanssens Y, Worthing E. Symptomatic and prophylactic treatment of migraine: a critical reappraisal. Clin Neuropharmacol 1998; 21(5):267-279; and Stewart W F, Lipton R B, Celentano D D, Reed M L. Prevalence of migraine headache in the United States: relation to age, income, race, and other sociodemographic factors. JAMA 1992; 267:64-69.) When given early, anti-migraine medications effectively abort the acute symptoms of a migraine attack and the prodrome symptoms. Most of these medications, such as ergotamine, its derivatives, and selective 5-hydroxytryptamine agonists, share the physiological property of causing vasoconstriction. (Deleu D, Hanssens Y, Worthing
Delacroix-Muirheid C.
Hodgson & Russ LLP
Jones Dwayne C.
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