Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
2001-08-24
2003-02-11
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S093400, C424S093480, C424S452000, C424S465000, C424S725000, C435S252900, C435S822000
Reexamination Certificate
active
06517832
ABSTRACT:
CROSS REFERENCE TO OTHER APPLICATIONS
This is a non-provisional patent specification and claims submitted for an official filing receipt under Patent Code 111(a).
BACKGROUND OF THE INVENTION
Headaches range from the rare and excruciating type, known as clusters, through the common tension-type (stress-induced), to the somewhat less common, but notorious, migraine, with or without an aura effect. Migraines have been attributed to blood vessels in the brain being constricted and then relaxing, thus altering blood flow. It was thought early on that the pain of migraine was of vascular origin and caused by excessive dilation of branches of the common carotid artery bed. Currently, researchers are zeroing in on the trigeminal nerve system, and the nerve chemical Serotonin, in particular, as one set of candidate headache pain culprits.
While significant advances have been made in dealing with the pain of migraine, little has had a dramatic effect in preventing the next attack or curing the disease. Indeed, the dominant medical community generally describes migraine as an incurable disease of unknown cause. Many migraine sufferers have reached a level of total frustration due to the lack of help they receive from the dominate or alternative medical community. Most have visited multiple health care professionals and have tried numerous prescription, over the ouncter, and natural products in an attempt to find a solution.
Consequently, a variety of vaso-constrictor agents have been promoted to alleviate this type of headache. Such compounds were tested (or shown) to constrict the carotid artery bed of an anesthetized dog. A medically accepted treatment include use of the a complex heterocyclic compound of the substituted indoles. Sumatriptan succinate (IMITREX, Glaxo Group) is an example of such a complex organic compound that activates the chemical messengers which cause blood vessels in the brain to constrict, thus lessening the pain effects of a migraine. Compare U.S. Pat. No. 4,816,470 of Mar. 28, 1989 to Dowle et al, and U.S. Pat. No. 5,037,845, of Aug. 6, 1991 to Oxford. The current Physician's Desk Reference denotes a plethora of side effects with sumatriptan migraine therapy. Indeed, the FDA-approved labeling for IMITREX declares it is not effective for other types of head pain, and because of the risk of known side affects, that IMITREX is generally used when other treatments prove ineffective.
There have not been corresponding advances in the area of migraine preventatives. While there are a variety of preventative pharmaceutical approaches available, none has proven to be broadly effective for an extended time frame. Again, the side effects associated with the various options limits their value. It is also fairly common for preventative approaches to work for limited amounts of time. Indeed, we will be interested to follow our study group to document their condition six and twelve months down the road to see if the improvement they have experienced lasts.
Whatever the neurological pathway to migraine relief, less complex methods are desired, in using pharmacologically benign compositions, in formulations that are desirable alternatives to potent organic compositions like sumatriptan. The search for formulations and methods that are substantially devoid of the clinically-established side effects seen with complex organic compounds, are in order. Morever, formulations based on natural substances that are of low cost seem an economic imperative for those chronic migraine victims of more modest financial means.
The approach utilized in this study is based on a new theory as to the cause of migraine. We believe that migraine is the deterioration of normal function. We believe that this deterioration of normal function is in one of two areas; either the body is not getting what it needs (digestion), or the body is unable to remove waste and toxins from the body (elimination). By focusing our attention and efforts on returning the digestive function to normal and assisting the liver, kidneys, and spleen with targeted nutritional support, we believe that the manifestation of migraine will diminish or disappear in most sufferers. At the very least, we believe we can document a significant improvement in the quality of life for most migraineurs.
OBJECTS OF THE INVENTION
It is a principal object of the present invention to provide an economical alternative to costly prescription remedies for the prophylactic treatment of the condition often clinically described as migraine headache.
It is another object of the invention to provide an orally administerable formulation composed of low cost and benign natural substances, such as among those that have already been demonstrated as being beneficial and nutritional substances, that have been clinically shown to relieve refractory migraine.
Still another object of the invention is to provide a formulation that provides macro and micro nutrients that are conducive to good health while providing for the prophylactic treatment of migraine.
Yet another object of the invention is to provide formulations that lack the side affects liability of complex neuroleptic agents, like the substituted indoles, now serving as a prescription treatment of migraine.
SUMMARY OF THE INVENTION
According to the invention, there is provided a method of treating a human being suffering from the pain resulting from headache, migraine headache, and cluster headache by administering a pharmaceutically acceptable composition, comprising a number of selected active ingredients in an effective amount. Such a formulation of several discrete compounds is set out in Example I, together with one or more pharmacologically acceptable carriers or excipients. These prophylactic formulations are taken orally via gelatin capsules, usually being ingested on a daily basis.
In current usage of the two already established formulations comprising natural substances serving as a prophylactic regimen, has been seen to afford relief from migraine.
REFERENCES:
patent: 5589168 (1996-12-01), Allen et al.
patent: 5939076 (1999-08-01), Allocca
patent: 6113907 (2000-09-01), Khwaja et al.
patent: 6132724 (2000-10-01), Blum
patent: 6297273 (2001-10-01), Romanczyk
Marrongelle Jeffrey L.
Staverosky Thomas J.
Eglington A. R.
Naff David M.
Ware Deborah K.
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