Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-03-09
2003-07-22
Cook, Rebecca (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06596756
ABSTRACT:
This is a 371 of PCT/US99 filed Sep. 10, 1999.
The invention relates to a method for using N-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine (hereinafter referred to as “duloxetine”) for the treatment of persistent pain.
For some years, it has been recognized that the chemistry of serotonin and norepinephrine are extremely important in neurological processes, and pharmacologists and medical researchers have been very actively studying the mechanisms of those neurotransmitters in the brain. Concomitantly, the synthesis and study of pharmaceuticals which affect serotonin and norepinephrine processes in the brain are of great interest and are also being intensively studied, both by pharmaceutical chemists and by medical researchers as well.
Duloxetine inhibits the reuptake of both serotonin and norephinephrine, and is being investigated for use as an antidepressant. 3-aryloxy-3-substituted propanamines, such as duloxetine, have been disclosed in U.S. Pat. No. 5,023,269 as being useful for the treatment of pain. This patent, however, does not specify what forms of pain are treated. PCT/US95/13289 discloses that duloxetine is useful for the treatment and prevention of neuropathic pain and migraine. As stated therein, “Neuropathic pain, as distinct from other varieties of pain, emanates specifically from a neurologic source, as from a nerve which is unnaturally stressed, compressed or otherwise injured, it does not include pain emanating from an injury or inflammation of bone, muscle or other tissue.” PCT/US95/13289 defines migraine “as a headache, particularly a very severe headache, which occurs repetitively in patients subject to the condition. It has been treated with partial success with vasoconstrictors but no treatment of migraine in the prior art is reliably successful.”
For clinical purposes, pain may be divided into two categories: acute pain and persistent pain. Acute pain is provoked by noxious stimulation produced by injury and/or disease of skin, deep somatic structures or viscera, or abnormal function of muscle or viscera that does not produce actual tissue damage. On the other hand, persistent pain can be defined as pain that persists beyond the usual course of an acute disease or a reasonable time for an injury to heal or that is associated with a chronic pathologic process that causes continuous pain or the pain recurs at intervals for months or years. If pain is still present after a cure should have been achieved, it is considered persistent pain. For the purpose of the present invention, persistent pain can be chronic non-remitting or recurrent. The difference in definition between acute and persistent pain is not merely semantic but has an important clinical relevance. For example, a simple fracture of the wrist usually remains painful for a week to 10 days. If the pain is still present beyond the typical course of treatment, it is likely that the patient is developing reflex sympathetic dystrophy, a persistent pain syndrome that requires immediate effective therapy. Early and effective intervention potentially prevents the undue disability and suffering, and avoids the potential development of a condition that becomes refractory to therapy.
Acute and chronic pain differ in etiology, mechanisms, pathophysiology, symptomatology, diagnosis, therapy, and physiological responses. In contrast to the transitory nature of acute pain, persistent pain is caused by chronic pathologic processes in somatic structures or viscera, by prolonged and sometimes permanent dysfunction of the peripheral or central nervous system, or both. Also, persistent pain can sometimes be attributed to psychologic mechanisms and/or environmental factors.
Persistent pain is a disease state that is one of the most important health problems in industrialized nations throughout the world. Persistent pain and suffering, regardless of cause, has serious physical, behavioral, mental, psychologic, social, and economic effects on both the patient and the family, and is very costly to society.
The mental effects of prolonged or persistent pain are greatly influenced by the duration, intensity, and periodicity of the persistent pain, by the personality and psychologic makeup of the individual, and by various socioloaic and economic factors. The duration of the persistent pain is an important factor in determining the mental effects; for while the average individual can briefly bear, both psychologically and physiologically, even the most severe pain, if such pain is prolonged it exerts effects which cause mental and physical deterioration. Prolonged, persistent, and intense pain interferes with thought processes and dominates the entire organism.
The impact of persistent pain on society is equally devastating as its effects on the sufferer. Patients develop problems with their families and friends, and, as previously mentioned, decrease their social interactions. Household chores (cooking, caring for a sick child, etc.), social and familial obligations are frequently cancelled. Some patients are unable to work, some are ineffective at work, others are encouraged not to work, and still others lose their jobs because of frequent absences. In fact, the unemployment rate of some chronic pain conditions can be 4-5 times higher than the average unemployment rate in the United States. These profound societal effects may render the patient an economic liability rather than an asset.
Current therapies for persistent pain include opiates, barbiturate-like drugs such as thiopental sodium and surgical procedures such as neurectomy, rhizotomy, cordotomy, and cordectomy. These therapies have significant drawbacks. Opiates and barbiturate-like drugs have limiting side effects and are addictive. Tricyclic antidepressants and anticonvulsants are marginally effective, and also are associated with some limiting side effects. Electrical stimulation, e.g., TENS has limited success in chronic pain. Surgical procedures are expensive, irreversible and often fail to provide long-term relief from persistent pain. Faced with suboptimal therapy for persistent pain, the patient suffers more, complains more, and becomes more desperate and dissatisfied with their healthcare. As a consequence, the patient seeks and consumes more direct and indirect healthcare resources.
In light of these realities, there is a demand for more effective analgesic agents, targeted specifically for persistent pain, which have a superior safety and tolerability profile and are non-addictive. The ideal analgesic would reduce the awareness of pain, produce analgesia over a wide range of pain types, act satisfactorily whether given orally or parenterally, produce minimal or no side effects, and be free from a tendency to produce tolerance and drug dependence.
The present invention addresses the need for a safe and effective treatment of persistent pain by providing a method of treating persistent pain.
In accordance with the present invention, there is provided a method of treating persistent pain comprising the administration to a patient in need of such treatment of an effective amount of duloxetine.
The present invention also provides the use of duloxetine for the manufacture of a medicament for treating persistent pain.
Furthermore, the present invention provides the use of duloxetine for treating persistent pain.
The term “treating” for purposes of the present invention, includes prophylaxis or prevention, amelioration or elimination of a named condition once the condition has been established.
The term “patient” for purposes of the present invention is defined as any warm blooded animal such as, but not limited to, a mouse, guinea pig, dog, horse, or human. Preferably, the patient is human.
For purposes of the present invention, the term “acute pain” is defined as pain which is provoked by noxious stimulation produced by injury and/or disease of skin, deep somatic structures or viscera, or abnormal function of muscle or viscera that does not produce actual tissue damage.
The term “persistent pain” as used herein, is defined as pain that persists b
Goldstein David Joel
Iyengar Smriti
Simmons Rosa Marie Ademe
Anderson Arvie J.
Cook Rebecca
Eli Lilly and Company
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