Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2000-04-05
2001-12-25
Criares, Theodore J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S530000
Reexamination Certificate
active
06333352
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the field of treating vertigo, especially benign positional vertigo.
BACKGROUND OF THE INVENTION
Benign positional vertigo (BPV) is the most common cause of pathological vertigo. The cause of about half of the cases of BPV is unknown, particularly in the elderly, while the remaining cases are linked to causes such as head injury, vascular occlusion and viral labyrinthitis. Patients suffering from BPV develop brief episodes of vertigo. This particularly occurs while the patient is changing position in such tasks as bending over and standing up, extending the neck to acquire a more elevated view, getting in and out of bed, and turning over in bed. In most patients the symptoms spontaneously remit, but recurrence is frequent.
A possible cause of BPV is thought to be free-floating calcium carbonate crystals, normally attached to the utricular macule, which accidently enter the long arm of the posterior semicircular canal. One therapy for alleviating the symptoms of BPV has been a bedside positioning maneuver used to remove the debris from the posterior canal on the affected side. This manipulation of the head; however, does not cure all symptoms and requires the patient to visit the office of a medical practitioner capable of performing such a manipulation. BPV has also be treated with the administration of meclazine; however, few patients respond to meclazine.
SUMMARY OF THE INVENTION
In accordance with the present invention, the inventor has unexpectedly found that anti-epileptic drugs can be used to treat benign positional vertigo and symptoms of benign positional vertigo. For example, gabapentin or a salt of divalproex, such as divalproex sodium have been successfully used to treat benign positional vertigo. These two drugs have not been previously known for efficacy in treating benign positional vertigo. The invention also contemplates using anti-epileptic drugs, such as divalproex sodium or gabapentin for a prophylaxis treatment of migraine headaches which are at times associated with BPV.
In one embodiment of the present invention, a salt of divalproex, such as sodium divalproex, is administered in a pharmaceutically effective amount to a patient suffering from benign positional vertigo. Divalproex sodium is a coordination compound of sodium valproate and valproic acid in a 1:1 molar ratio and is chemically designated as sodium bis(2-propylpentanoate).
In another embodiment of the present invention, gabapentin is administered in a pharmaceutically effective amount to a patient suffering from benign positional vertigo. Gabapentin is chemically designated as 1-(aminomethyl)cyclohexaneacetic acid.
Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention involves administering an anti-epileptic drug to a patient suffering from BPV in a pharmaceutically acceptable amount. Examples of such anti-epileptic drugs include gabapentin or a salt of divalproex, such as divalproex sodium. Gabapentin is offered by Parke-Davis under the trademark Neurontin® in hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients include lactose, cornstarch, talc, gelatin, and titanium dioxide. Divalproex sodium is a stable coordinated compound of sodium valproate and valproic acid in a 1:1 molar ratio and is formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Divalproex sodium is sold by Abbott Laboratories under the trademark Depakote® in tablets with dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. The inactive ingredients include cellulosic polymers, diacetylated monoglycerides, povidone, pregelatinized starch, silica gel, talc, titanium oxide and vanillin.
The inventor has also observed that the following relationship is often true in the diagnosis of BPV and subsequent treatment with Neurontin® or Depakote®. Symptoms of BPV include vertigo when changing position in such tasks as bending over and standing up, extending the neck to acquire a more elevated view, getting in and out of bed, turning over in bed looking up, bending over, looking down, getting up, and lying down. When symptoms of BPV have occurred in relationship to a virus, such as vestibular neuronitis, several weeks of treatment are needed to eliminate or reduce the BPV symptoms. If BPV manifests itself in relationship to a head trauma, two to three months of treatment are generally required. When symptoms of BPV are ediopathic (unknown), several months to an indefinite time may be required to control the symptoms of BPV. When patients do not respond to either medication, this is often because the cause of the positional vertigo is due to a structural lesion.
Neurontin® or Depakote® can be prescribed at any dosage that is effective in relieving symptoms of BPV or BPV associated with a migraine headache. The inventor has found an effective dosage range of Depakote® to be 250 to 1,000 mg taken twice a day. Neurontin® has found to be effective in the dosage range of 400 to 1,200 mg taken twice a day. The following are actual patient histories of individuals treated with Neurontin® or Depakote®. In most patients the following symptoms of BPV were reduced within a week and did not reoccur after a few weeks or months of treatment. Treatment for most patients was discontinued after a few months. It has also been discovered that symptoms of BPV associated with migraine headaches can be effectively treated with the use of Neurontin® or Depakote®. Either drug can act as a prophylaxis in preventing the onset of migraine headaches.
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Davies, “Mechanism of action of antiepileptic drugs”, British Epilepsy Association, Seizure, pp. 267-272, 1995.
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Criares Theodore J.
Heller Ehrman White & McAuliffe LLP
Kim Jennifer
Mimicking Man Manually, Inc.
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