Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2000-08-08
2003-01-07
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S221000, C514S401000, C514S617000, C514S567000, C514S811000, C514S634000, C514S278000, C514S225200, C514S263370, C514S317000, C514S654000, C514S376000, C514S377000, C514S653000
Reexamination Certificate
active
06503950
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the treatment of alcohol and narcotic withdrawal symptoms associated with alcohol and narcotic addiction.
2. Description of the Related Art/Background Information
Alcohol and narcotic withdrawal symptoms associated with patient populations undergoing drug abuse treatment has become an important concern to those patients and their families as well as treating health care personnel. Due to alcohol and narcotic abuse, use, and the high rate of relapse to regular use, the management of withdrawal side effects is becoming increasingly important for the long-term rehabilitation of patients overcoming drug abuse addiction. Current treatment modalities for drug abuse can create or potentiate side effects from those medications used to treat alcohol or narcotic withdrawal. Frequently encountered side effects include depression, dizziness, orthostatic hypotension, drowsiness, lethargy, difficulty in being mobile, and weakness in the extremities. Such negative side effects prolong patient therapy or interfere with detoxification procedures, which leads to further use, abuse, and relapses to regular use, requiring subsequent detoxification. treatment episodes.
The prior art teaches the use of benzodiazepines separately for the treatment of anxiety caused by a variety of conditions, including withdrawal. For example, the drug monograph for benzodiazepines listed within the
Drug Facts and Comparisons
, 1999 ed., Wolters Kulwar Co. 1998, p. 1600-03, indicates that such agents, through interaction with gamma-aminobutyrate (GABA) and BZ
1
and BZ
2
receptors in the human body, create a calming effect and subsequent reduction or prevention of anxiety. The prior art also teaches the use of azaspirodecanediones, such as buspirone, as an anxiolytic agent, because of their calming effect caused by interaction with 5-HT
1
A and GABA receptors in the human body. Id. Finally, the prior art also teaches the use of piperazine derivatives, such as hydroxyzine, to create a calming effect in the human body through interaction with spasmogenic receptors for serotonin, acetylcholine and histamine. Id. at 1604-07. Yet, all these anxiolytic agents, due to their drug chemistry, cause the side effects of drowsiness, depression, lethargy, and difficulty in being mobile in patients undergoing drug abuse treatment. Such negative side effects frequently increase the need to treat such patients in an in-patient only setting to prevent the risk of injury.
The individual use of centrally acting alpha antiadrenergic agents to reduce central and peripheral nerve agitation and increased blood pressure associated with narcotic and alcohol withdrawal has been taught by the prior art. The use of such agents can decrease central and peripheral nerve agitation, yet, frequently cause depression, dizziness, drowsiness, lethargy, orthostatic hypotension, and weakness in the extremities.
Drug Facts and Comparisons
. 1999 ed., 1998, p. 967-68, 1444-45. In addition, when a centrally acting alpha antiadrenergic agent, such as clonidine, is added to an existing drug treatment regimen, already containing an anxiolytic agent, an additive effect for dizziness, drowsiness, depression, lethargy, weakness in the extremities, orthostatic hypotension, and difficulty in being mobile occurs.
Drug Facts and Comparisons
. 1999 ed., 1998, p. 967-68, 1444-45. This further exacerbates the need for in-patient care due to the increased risk of injury to patients and liability to healthcare personnel treating such patients.
U.S. Pat. No. 5,668,117 to Shapiro, discloses a method of treating neurological diseases and etiology by utilizing carbonyl-trapping agents in combination with previously known medicaments. Shapiro discloses the ability of combining a carbonyl-trapping agent with either a benzodiazepine or a centrally acting alpha antiadrenergic agent.
Prior art U.S. Pat. No. 4,829,070 to Boder, discloses the use of a redox carrier system for the site-specific delivery of a centrally acting therapeutic agent to the brain. Boder discloses the ability of attaching a centrally acting alpha antiadrenergic agent or benzodiazepine to the redox carrier system and delivering those agents to the brain.
U.S. Pat. No. 5,855,908 to Stanley, discloses a non-dissolvable dosage form for use in the transdermal delivery of a drug to a patient which includes clonidine or a benzodiazepine agent, such as lorazepam, to be carried by such a transdermal system.
U.S. Pat. No. 5,474,783 to Miranda, discloses a pressure sensitive adhesive transdermal drug delivery system which includes an adhesive carrier that holds a therapeutic agent such as a centrally acting alpha antiadrenergic agent or anxiolytic agent, or central nervous system stimulant agent to be delivered to the human body.
Prior art clinical addiction treatment literature includes many descriptions of patients having an incipient form of a disease, such as alcohol or narcotic addiction, who show the recognized symptoms of the disease, such as withdrawal. It should be understood by those skilled in the art that a narcotic is a drug that dulls the senses, relieves pain, and produces sleep, such as an opiate or benzodiazepine. Treatment options for side effects associated with conventional drug therapies used to treat the established clinical withdrawal side effects of alcohol and narcotic addiction have not been reported.
Prior art clinical neurology literature includes many descriptions of patients having increased drowsiness, dizziness, depression, weakness in the extremities, lethargy, orthostatic hypotension, and difficulty in being mobile associated with treatments utilizing anxiolytic agents and centrally acting alpha antiadrenergic agents for the reduction or prevention of alcohol or narcotic withdrawal symptoms such as anxiety, central and peripheral nerve agitation, and hypertension associated with alcohol and narcotic addiction. Dunagan, W. and Ridner, M.,
Manual of Medical Therapeutics
, 26th ed., Boston, Little, Brown, 1989, p. 6-7, 474-75. Clinical cardiology literature in the prior art includes many descriptions of patients experiencing orthostatic hypotension and other side effects associated with centrally acting alpha antiadrenergic agents utilized to treat hypertension and central and peripheral nerve agitation experienced during alcohol or narcotic withdrawal management. Woodley, M. and Whalen A.,
Manual of Medical Therapeutics
, 27th ed., Boston, Little, Brown, 1992, p. 64-75.
Due to the lack of clinical literature and study of withdrawal side effect management, such as depression, dizziness, drowsiness, weakness in the extremities, lethargy, orthostatic hypotension, and difficulty in being mobile associated with the use of centrally acting alpha antiadrenergic agents and anxiolytic agents, many patients do not initiate or continue an alcohol or narcotic abuse treatment program. Further, due to the increased orthostatic hypotension associated with the use of centrally acting alpha antiadrenergic agents, an increased risk of syncope and injurious fall to patients undergoing abuse treatment has been frequently observed. This increased risk further prompts the need to treat such patients in an in-patient only setting to decrease the risk of liability for health care personnel providing treatment. Yet, in doing so, healthcare costs are substantially increased.
SUMMARY OF THE INVENTION
A pharmaceutical kit, composition, and method of treatment regimen for alcohol and narcotic withdrawal side effects of therapeutic agents used to treat alcohol or narcotic withdrawal symptoms has been discovered, utilizing a centrally acting alpha antiadrenergic agent, a central nervous system stimulant agent (CNS), and an anxiolytic agent in combination. The present invention reduces or prevents the side effects of depression, dizziness, drowsiness, lethargy, weakness in the extremities, difficulty in being mobile, and orthostatic hypotension associated with therapeutic agents used to treat alcohol and narcotic withdrawal wit
Nguyen Helen
Price Heneveld Cooper DeWitt & Litton
Webman Edward J.
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