Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – N-c doai
Reexamination Certificate
2002-02-21
2003-07-08
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
N-c doai
C514S488000, C514S489000
Reexamination Certificate
active
06589985
ABSTRACT:
FIELD OF THE INVENTION
This invention is directed to a method for use of a carbamate compound in preventing or treating movement disorders. More particularly, this invention is directed to a method for use of halogenated 2-phenyl-1,2-ethanediol monocarbamate or dicarbamate compounds for preventing or treating movement disorders.
BACKGROUND OF THE INVENTION
Movement disorders are a broad group of disorders without a single underlying cause, resulting from a variety of neurological dysfunctions directly or indirectly linked to neuronal damage or abnormalities in nervous system pathways (Blandini F, et. al., Movement disorders,
Princ. Neural. Aging,
1997, 441-453; Koller W C, et. al., Pharmacologic treatment of essential tremor,
Neurology,
2000, 54 (11, Suppl. 4), S30-S38; Gasser T, et. al., Genetics of Parkinson's disease and other movement disorders,
Neurogenetics,
2000, 351-372; Collado-Seidel V, et. al., Aetiology and treatment of restless legs syndrome, CNS
Drugs,
1999, 12 (1), 9-20; Bucher S F, et. al., Cerebral generators involved in the pathogenesis of the restless legs syndrome,
Annals of Neurology,
1997, 41 (5), 639-45; Kanazawa I, Extrapyramidal tract symptoms in degenerative diseases. Involuntary movement in degenerative diseases. Huntington's disease, chorea-acanthocytosis and benign hereditary chorea.
Saishin Naikagaku Taikei,
1997, 68, 156-163; Scheidt C E, Psychosomatic aspects of idiopathic spasmodic torticollis. Results of a multicenter study.
Psychotherapie, Psychosomatik, Medizinische Psychologie,
1998, 48 (1), 1-12; Caligiuri M P, Antipsychotic-induced movement disorders in the elderly: epidemiology and treatment recommendations,
Drugs Aging,
2000, 17 (5), 363-384; Poewe W, What is new in movement disorders,
Wien. Klin. Wochenschr.,
1999, 111 (17), 664-671; Klein C, et. al., Evaluation of the role of the D2 dopamine receptor in myoclonus dystonia,
Ann. Neurol.,
2000, 47 (3), 369-373).
Such movement disorders include, but are not limited to, benign essential tremor (ET), tremor in Parkinson's disease (PD) and Parkinsonism, other non-related ET or PD tremors (such as head/limb resting, simple kinetic and intention, postural-associated, position-associated, orthostatic, enhanced physiologic, psychogenic, task-associated, voice, cerebellar, rubral and other central and non-classical tremors), restless leg syndrome (RLS), restless arm syndrome (RAS), chorea in Huntington's disease, idiopathic torsion dystonia, focal torsion dystonia, myoclonus, athetosis, abnormal movements in Wilson's disease, Gilles de La Tourette's syndrome, paroxysmal movement disorders (including paroxysmal dystonia (eg, kinesgenic paroxystic choreoathetosis, dystonic paroxystic choreoathetosis, intermediate paroxystic choreoathetosis and nocturnal paroxystic choreoathetosis), paroxystic ataxia and paroxystic tremor), post-anoxic spasms, post-spinal cord injury spasms, multiple sclerosis-associated tremor and drug-induced tremors and movement disorders (including, and not limited to, postural tremor, acute dystonia, chorea, akathisia, tardive dyskinesia and Parkinson's-like syndromes).
Antiepileptic drugs have been used to treat a variety of nonepileptic conditions including movement disorders (Ettore B, The use of anticonvulsants in neurological conditions other than epilepsy: A review of the evidence from randomized controlled trials,
CNS Drugs,
1999, 11 (1), 61-82). Essential tremor is a common disorder with oscillating movements that often causes functional disability, potentially leading to physiological and emotional difficulties. Its prevalence is about 3.5-55 per 1000 population (Tanner C M, Epidemiology of Movement disorders. In: Anderson D W editor.
Neuroepidemiology,
CRC Press, 1991, 193-216). Beta-receptor blocking agents (propranolol and analogues) are a line of therapy for essential tremor (Iwata S, et. al., Effects of beta-adrenergic blockers on drug-induced tremors,
Biochem. Behav.,
1993, 44 (3), 611-13). However, in addition to the incomplete clinical response, beta-receptor blocking agents are contraindicated in asthma, heart block, or congestive heart failure and must be used judiciously in patients with diabetes mellitus or recurrent depression.
In various conditions, anticonvulsants (such as carbamazepine, gabapentin and topiramate) may be effective in treating essential tremor. Topiramate given to nine patients with essential tremor may be useful for the management of essential tremor, especially in patients partially responsive to other established forms of treatment (Galvez-Jimenez N and Hargreave M, Topiramate and essential tremor,
Ann. Neurol,
2000, 47 (6), 837-838). Eight patients rated themselves as better and with less disability after topiramate therapy. One patient reported increased diuresis while receiving topiramate. The most common side effects were fatigue and paresthesias. Gabapentin, an antiepileptic, has been used for treating essential tremor (Koller W C, Pharmacologic treatment of essential tremor,
Neurology,
2000, 54 (11), (Suppl. 4), S30-S38). In an open-label report, gabapentin reduced tremor in five patients. Three of the patients elected to remain on gabapentin as opposed to their previous medication. Carbamazepine and gabapentin have shown effectiveness in treating essential tremor (Ettore B, The use of anticonvulsants in neurological conditions other than epilepsy: A review of the evidence from randomized controlled trials,
CNS Drugs,
1999, 11 (1), 61-82). Other anticonvulsants may also be effective in treating essential tremor (Koller W C, Pharmacologic treatment of essential tremor,
Neurology,
2000, 54 (11), (Suppl. 4), S30-S38; Gorman W P, et. al., A comparison of primidone, propranolol in essential tremor, using quantitative analysis,
J. Neurol. Neurosurg. Psychiatry,
1986; 49, 64-68; Gironell A, et. Al., A randomized placebo-controlled comparative trial of gabapentin and propranolol in essential tremor,
Arch. Neurol.,
1999, 56, 475; Leslie M, Nonepileptic uses of gabapentin,
Epilepsia,
1999, 40 (Suppl. 6), S66-S72; 837-838; Ettore B, The use of anticonvulsants in neurological conditions other than epilepsy: A review of the evidence from randomized controlled trials,
CNS Drugs,
1999, 11 (1), 61-82).
RLS and RAS are common, chronic disorders characterized by a need to move the legs or arms, especially when relaxed. These neurological movement disorders also affect induction of sleep and can become a significant source of sleep-disturbance because of the compulsive movement of the extremities; such disorders and consequences can also be associated with paresthesias and excessive daytime tiredness. There is 1-5% prevalence of these disorders in the general population and 15% in the medical population. The etiology of RLS remains unknown. Levodopa/decarboxylase inhibitors (carbidopa, benserazide) and dopamine agonists are regarded as a line of treatment for RLS. The development of time shift and/or augmentation of symptoms is a major problem with dopaminergic treatment. Importantly, anticonvulsants such as gabapentin and carbamazepine also have efficacy in RLS (Adler C H, Treatment of restless legs syndrome with gabapentin,
Clin. Neuropharmacol.,
1997, 20 (2), 148-151; Merren M D, Gabapentin for treatment of pain and tremor: a large case series,
South Med. J.,
1998 Aug, 91 (8), 739-44; Wetter T C, Pollmacher T, Restless legs and periodic leg movements in sleep syndromes,
J. Neurol,
1997 Apr, 244 (4 Suppl 1), S37-45). The efficacy of anticonvulsants in movement disorders such as essential tremor and RLS is thought to be due, in part, to the neurostabilizing properties of this class of drugs, which may restore the imbalance in the generation and transmission of motor impulses.
Substituted phenyl alkyl carbamate compounds have been described in U.S. Pat. No. 3,265,728 to Bossinger, et al (hereby incorporated by reference), as useful in treating the central nervous system, having tranquilization, sedation and muscle relaxation properties of the formula:
wherein R
1
Plata-Salaman Carlos R.
Twyman Roy E.
Zhao Boyu
Jarvis William R. A.
Ortho-McNeil Pharmaceutical , Inc.
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