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(12) Patent Application Publication (10) Pub. No.: US 2013/0165511 A1 Lederman Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2013/0165511 A1 Lederman Et Al US 2013 O165511A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0165511 A1 Lederman et al. (43) Pub. Date: Jun. 27, 2013 (54) TREATMENT FOR COCANE ADDICTION Publication Classification (75) Inventors: Seth Lederman, NEW York, NY (US); (51) Int. Cl. Herbert Harris, Chapel Hill, NC (US) A63/37 (2006.01) A63/6 (2006.01) (73) Assignee: TONIX Pharmaceuticals Holding (52) U.S. Cl. Corp, New York, NY (US) CPC ............... A61K 31/137 (2013.01); A61K3I/I6 (2013.01) (21) Appl. No.: 13/820,338 USPC ........................................... 514/491; 514/654 (22) PCT Fled: Aug. 31, 2011 (57) ABSTRACT (86) PCT NO.: PCT/US11/O1529 A novel pharmaceutical composition is provided for the con S371 (c)(1), trol of stimulant effects, in particular treatment of cocaine (2), (4) Date: Mar. 1, 2013 addiction, or further to treatment of both cocaine and alcohol dependency, including simultaneous therapeutic dose appli Related U.S. Application Data cation or a single dose of a combined therapeutically effective (60) Provisional application No. 61/379,095, filed on Sep. composition of disulfiram and selegiline compounds or phar 1, 2010. maceutically acceptable non-toxic salt thereof. US 2013/01655 11 A1 Jun. 27, 2013 TREATMENT FOR COCANE ADDCTION the United States in 2005. In the sense of this invention the term “addiction' may be defined as a compulsive drug taking CROSS-REFERENCE TO RELATED or abuse condition related to “reward’ system of the afflicted APPLICATIONS: patient. The treatment of cocaine addiction or dependency 0001. The present application which claims priority from has targeted a lowering of dopaminergic tone to help decrease U.S. Provisional Patent Application No. 61/379,095, filed or attenuate the “reward effect. Behavioral interventions may Sep. 1, 2010, is a continuation in part from U.S. patent appli help in treating cocaine addiction, but have not yet resulted in cation Ser. No. 12/145,792, filed Jun. 25, 2008, which is a approved medications to treat these disorders despite many divisional of U.S. patent application Ser. No. 10/287,153, years of study. filed Nov. 4, 2002 (abandoned), which claims the benefit of 0008 Moreover, cocaine users tend to imbibe alcohol con the filing date of U.S. Provisional Patent Application No. currently to mellow the psychological anxiety and hyperagi 60/338,901, filed Nov. 5, 2001, the entire contents of which tation frequently associated with chronic use of cocaine. It are incorporated by reference. appears that almost 90% of cocaine abusers are also depen dent on alcohol. The consumption of both cocaine and alco BACKGROUND hol has been suggested as reinforcing the dependency and toxicity in the formation of the metabolite, cocaethylene. 0002 All references cited in this specification, and their Alcohol abuse and dependence commonly lead to other prob references, are incorporated by reference herein in their lems such as alcohol-related violence, motor vehicle acci entirety where appropriate for teachings of additional or alter dents, and medical consequences of chronic alcohol ingestion native details, features, and/or technical background. including death. 0009. The enzyme aldehyde dehydrogenase (ADLH) BACKGROUND OF THE INVENTION inhibitor disulfiram which is also dopamine-beta-hydrolase 0003 1. Field of the Invention (DBH) inhibitor has been reported effective in studies for 0004. The present invention relates to compositions and reducing cocaine use (Carroll et al. Arch. Gen. Psychiatry methods for preventing, ameliorating or treating addiction to 2004:29:1123-1128), although perhaps not suitable for all cocaine, alcohol and similar nerve or psycho-stimulants. populations (Nich et al. Addict. Behavior 2004; 29:1123 Such compositions and methods may be used to facilitate 1128). Selegiline, a monoamine oxidase (MAO)-B inhibitor, drug use cessation, and may comprise a combination of alde is known to block dopamine breakdown, thus increasing Syn hyde dehydrogenase inhibitors and monoamine oxidase aptic dopamine levels and inhibit dopamine re-uptake (Ebadi inhibitors; more particularly, the treatment may include a et al. J. Neurosci. Res. 2002: 67:285-289). single dosage unit of such combined active ingredients. Such 0010 Although disulfiram and selegiline have been avail compositions will reduce pleasurable experiences associated able on the market for many years, their combined use has with use of alcohol, cocaine, or stimulants. In addition, Such never been Studied systematically. Despite widespread use, a compositions will produce unpleasant or aversive experi single case report has appeared in the literature involving a ences when used with alcohol, cocaine, or stimulants. Lastly, significant adverse event (transient delirium) associated with Such compositions have mildly reinforcing properties that administration of an MAO inhibitor tranylcypromine in a may enhance compliance with their use in Subjects prone to patient with a disulfiram implant on therapeutic lithium Substance abuse. (Blansjaar, B.A. 1995 Am J Psychiatry 152:296.) It should be 0005 2. Description of the Related Art noted that tranylcypromine is an inhibitor of MAO-A and-B. 0006 Cocaine, stimulants, and alcohol are recognized as Selegiline selectively inhibits only the enzyme monoamine the most commonly abused drugs. According to the Diagnos oxidase B (MAO-B) at the low dose of 10 mg/day or less. tic and Statistical Manual of Mental Disorders (DSM-IV), Moreover, the subject in the case report also had a therapeutic problematic alcohol use is divided into alcohol abuse and level of Li'(0.7 mM/L in serum), factors which may have alcohol dependence. Cocaine abuse and dependence remains contributed to the delirium. a substantial problem in the United States of America. Stimu 0011. One of the pharmacotherapies that have been sug lants are drugs that tend to increase alertness and physical gested for treating alcoholism, including facilitating alcohol activity. The groups include pharmaceuticals such as amphet cessation, is the administration of agents that inhibiting the amines and the Street drugs commonly called “uppers' or enzyme aldehyde dehydrogenase (ALDH), an enzyme “speed,” and cocaine. Specific examples include cocaine, involved in the removal of acetaldehyde, a toxic metabolite of methamphetamine, amphetamines, methylphenidate, nico alcohol. Examples of ALDH inhibitors include, e.g., disul tine, and MDMA (3.4-methylenedioxymethamphetamine), firam, coprine, cyanamide, 1-aminocyclopropanol (ACP), better known as “Ecstasy.” Clinically significant abuse or daidzin, cephalosporins, antidiabetic Sulfonyl ureas, metron dependence on these Substances is classified by the Diagnos idazole, and any of their metabolites or analogs exhibiting tic and Statistical Manual (DSM-IV) as follows: Amphet ALDH-inhibiting activity including, e.g., S-methyl N,N-di amine abuse (305.70)/Amphetamine dependence (304.40); ethyldithiocarbamate, S-methyl N,N-diethyldithiocarbamate Cocaine abuse (305.60)/Cocaine dependence (304.20); Phen sulfoxide, and S-methyl N,N-diethylthiocarbamate sulfox cyclidine abuse (305.90)/dependence (304.90); Nicotine ide. Patients who consume such inhibitors of ALDH experi dependence (305.1) (Amperican Psychiatric Association, ence mild to severe discomfort if they ingest alcohol. The 2000). efficacy of therapies using ALDH inhibitors depends on the 0007 Cocaine dependence has developed into a public patients own motivation to self-administer the ALDH inhibi health problem with negative medical, social, and economic tors, e.g., oral forms of the inhibitors, or to receive additional effects. For example, in recent years cocaine-related emer therapies, e.g., DEPO forms of disulfiram. In fact, patient gency room visits increased almost 50%. Cocaine addiction compliance is a significant problem with these types of thera or dependence affected approximately 2.4 million people in pies. Disulfiram therapy is known to require close medical US 2013/01655 11 A1 Jun. 27, 2013 Supervision for maintenance of abstinence/relapse preven Katz, Kosten et al. 1998). In a more recent study, (Baker, tion. Some of the reasons for this difficulty are described in Jatlow et al. 2007) reported that disulfiram treatment, in the following paragraphs. addition to increasing aversive experiences associated with 0012. Although multiple forms of ALDH exist, ALDH-I cocaine, also attenuated the “high feelings, (Baker, Jatlow et (also known as ALDH-2) and ALDH-II (also known as al. 2007). Another possibility is that disulfiram, through inhi ALDH-1) are the major enzymes responsible for the oxida bition of the enzyme DBH. may increase the amount of tion of acetaldehyde. ALDH-I has a higher affinity for acetal dopamine in the brain by blocking dopamine's conversion to dehyde than ALDH-II, and is thought to be the primary norepinephrine and thereby increase the dopamine that enzyme involved in alcohol detoxification Keung, W. M., et amphetamine releases (Karamanakos, Pappas et al. 2001). As al., Proc. Natl. Acad. Sci. USA 95:2198-2203 (1998). The the concurrent abuse of cocaine with alcohol is both increas discovery that 50% of the Asian population carries a mutation ingly common, it has become an intractable clinical problem in ALDH-I that inactivates the enzyme, together with the low for pharmacotherapeutic approaches. The problem of treat occurrence of alcohol abuse in this population Supports the ment either alcohol or cocaine abuse or both is one of efficacy contention that it is this isozyme of ALDH that is primarily
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