Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1998-12-23
2001-02-27
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S312000, C514S313000, C514S314000, C514S381000, C514S443000
Reexamination Certificate
active
06194432
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention is in the field of pharmacology, and relates to drugs that can help reduce the frequency, duration, and/or severity of certain types of headaches that are classified as “recurrent primary headaches”, including migraine headaches and cluster headaches. The treatment disclosed herein involves daily or other chronic administration of “leukotriene antagonist” drugs, which previously have been used for treating asthma.
As is well-known, migraine headaches (also referred to simply as migraines, for convenience) are severe types of headaches. Typically, migraines are distinguished from ordinary headaches by several factors. Migraines with aura (referred to in the past as “classic” migraines) affect approximately 20% of migraine sufferers, and are usually preceded or accompanied by some type of visual, sensory or motor disturbance, known as an aura. Migraines without aura (previously known as “common” migraines) usually affect one side of head only, last between 4 and 72 hours, and are usually accompanied by nausea, vomiting, or similar symptoms. To establish a diagnosis of migraine without aura, there must have been at least 5 previous episodes; organic factors which may mimic migraine must have been ruled out; and, the attack must last 4 to 72 hours.
“Cluster headaches” were given that name because they tend to occur in episodic clusters, with a cluster cycle usually lasting 4 to 8 weeks. In some patients, a cluster occurs only once in a lifetime; in other patients, a cluster may occur roughly once a year, pith periods of complete remission between attacks; and, in the roughly 10% of patients who are chronic sufferers, there are no significant periods of remission. As opposed to migraines (which occur in women at roughly 3 times the rates as in men), cluster headaches are more prevalent in men than in women, by a factor of about 5:1 or higher.
In cluster headaches, the rain is almost always one-sided, and typically involves the eye and temple region. As opposed to migraine, which may he a throbbing type of pain, the pain of a cluster headache is almost always non-throbbing, and is often likened by the patient to a red hot poker being driven into the affected eye, with immense force. Attacks generally last about 45 to 90 minutes, and may occur several times a day. They also fairly often awaken a sufferer from sleep, when in cycle. Symptoms accompanying such attacks generally include a red and tearing eye, stuffed and running nostril, and drooping of the eyelid, all on the side of the attack. As opposed to migraine patients, who must retreat to a dark and quiet environment, the pain of cluster headaches is usually so intense that the sufferer often paces, rocks, walks about, or does anything else that may help distract him from the pain (including, in many cases, banging his head or fists against the wall, ground, or other object).
Migraines and cluster headaches are both important, well-known, and extensively studied medical problem. In many cases, they completely incapacitate a sufferer for the duration of the headache. Their physiological aspects, causative and aggravating factors, and current Treatments are discussed in detail in numerous scientific articles, and in full-length medical textbooks such as
Headache in Clinical Practice
(edited by S. Silberstein et al., Oxford Univ. Press, 1998);
The Headaches
, by J. Olesen; and
Headache Disorders: A Management Guide for Practitioners
, by A. Rapoport and F. Sheftell (W. B. Saunders, Philadelphia, 1996). In addition, various definitions, categories, and diagnostic standards are defined by standardized criteria that have been approved and issued by the International Headache Society (IHS), which were published as a supplement to the journal
Cephalalgia
in 1988.
Migraines and cluster headaches are both classified as “recurrent primary headaches”. They are recurrent, since they recur with sufficient frequency to seriously interfere with the health and quality of life of a patient, to a point of requiring and demanding medical attention, as opposed to just taking aspirin or similar over-the-counter analgesics and lying down till it passes. They are also regarded as “primary” headaches, since they usually arise as a primary adverse biologic condition, independently of other causative medical conditions such as tumors, sinus or other infections, bleeding problems, etc.
A third major category of recurrent primary headaches is often referred to as “tension” (or “tension-type”) headaches. Although these can often be resolved in many patients if the source of the tension can somehow be eliminated or substantially lessened, that approach may require a major lifestyle change for the patient, and is often impractical or impossible for patients who cannot escape from the demands imposed by stressful work, family, or other situations. Accordingly, recurrent tension headaches must often be treated as a medical problem using drug intervention, usually in combination with training in relaxation and stress management techniques. In addition, many researchers and physicians believe that tension headaches and migraine headaches exist on a continuum, and involve the same or overlapping neurobiological mechanisms. It should also be noted that various drugs (including anti-inflammatory drugs, such as certain types of prostaglandin antagonists) that are effective (in at least some patients) in treating migraine headaches are also effective in treating tension headaches as well. Because of their similarities and overlapping factors, it is believed by the Applicant that tension headaches may be susceptible to effective treatment, in at least some sufferers, using leukotriene antagonist drugs as disclosed herein.
There are at least three “aspects” or “traits” of primary recurrent headaches that are important in this invention, since these traits can provide quantifiable evidence of whether a treatment is or is not effective in controlling such headaches. Those three aspects are: (1) frequency, which is usually evaluated over a span of time, such as number of such headaches per week, per month, or per year; (2) duration, which evaluates (usually in hours) how long a headache lasts, from the time it begins to develop into a migraine or cluster headache, until it has been resolved; and, (3) severity (also referred to as intensity), which is based on subjective estimates of the severity or intensity of pain or other side effects (such as nausea) being suffered by patients during such headaches.
If a preventive drug treatment can significantly reduce any one of these three aspects (frequency, duration, or severity), even if it has no noticeable effects on the other two aspects, then the preventive treatment can and should be regarded as effective, successful, and beneficial to patients, since that treatment can substantially improve the quality of life for such patients.
For obvious reasons, an ideal preventive treatment would reduce all three aspects; and, indeed, the preventive treatment disclosed herein does indeed appear to accomplish that ideal goal, in at least some patients, based on an initial open-label trial. However, it must be noted that simultaneously reducing all threes aspects of headaches is not essential to providing useful and effective relief from severe headaches. A treatment which can reduce any one (or two) of those goals is effective and useful from a medical perspective, and will be enthusiastically welcomed by sufferers of migraine and/or cluster headaches (and by their families and friends).
Migraines are more common than cluster headaches, and have been studied more extensively. In addition, a better and more effective set of drugs have been developed to treat migraines, than cluster headache. For those reasons, the discussion below focuses mainly on migraines, rather than cluster headaches. However, because of various physiological and pharmacological factors, and because of the highly positive results observed so far in initial tests on migraine sufferers, it is believed by the Applicant
Kevorkian Robert C.
Sheftell Fred D.
Kelly Patrick D.
Krass Frederick
Sheftell Fred D.
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