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(12) Patent Application Publication (10) Pub. No.: US 2012/0022122 A1 Tokunaga (43) Pub US 20120022122A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0022122 A1 Tokunaga (43) Pub. Date: Jan. 26, 2012 (54) TREATMENT AND PREVENTION OF Publication Classification DELETERIOUS EFFECTS ASSOCATED (51) Int. Cl. WITH ALCOHOL CONSUMPTION A6II 3/426 (2006.01) A6IP 25/32 (2006.01) (76) Inventor: Richard Tokunaga, Honolulu, HI (52) U.S. Cl. ........................................................ 514/370 (US) (57) ABSTRACT The present invention provides to methods and compositions (21) Appl. No.: 13/248,375 that treat or prevent deleterious effects associated with alco hol consumption including alcohol-induced flush reaction and hangover. The methods and compositions include famo (22) Filed: Sep. 29, 2011 tidine and optionally succinic acid. The present invention further demonstrates compositions that include famotidine Related U.S. Application Data are effective at treating symptoms associated with a flush reaction in Subjects that are not significantly responsive to (62) Division of application No. 12/323,098, filed on Nov. treatments with the H1 antagonist loratidine or the H2 antago 25, 2008, now Pat. No. 8,058,296. nist cimetidine. Patent Application Publication Jan. 26, 2012 Sheet 1 of 2 US 2012/0022122 A1 FIG. 1 F.G. 2 Patent Application Publication Jan. 26, 2012 Sheet 2 of 2 US 2012/0022122 A1 FIG. 3A FIG. 3B US 2012/0022122 A1 Jan. 26, 2012 TREATMENT AND PREVENTION OF contributes to hangover, which is often felt by many the DELETERIOUS EFFECTS ASSOCIATED morning after alcohol consumption. Common hangover WITH ALCOHOL CONSUMPTION effects include headache, nausea, dizziness, fatigue, thirst, tension, anxiety, paleness, tremorand perspiration. It is com CROSS REFERENCE TO RELATED monly believed that black coffee or further consumption of APPLICATIONS alcohol in the morning reduces the symptoms; however, the effectiveness varies across individuals. 0001. The present invention is a divisional of U.S. patent 0007 Accordingly, there remains a need to develop new application Ser. No. 12/323,098, filed Nov. 25, 2008 and is methods and compositions for the treatment and prevention herein incorporated by reference in its entirety. of deleterious effects associated with alcohol consumption. TECHNICAL FIELD OF THE INVENTION SUMMARY OF THE INVENTION 0002 The present invention relates to the prevention or 0008. The present invention addresses deficiencies in treatment of effects associated with alcohol consumption and methods and compositions for the treatment or prevention of more specifically to methods and compositions for the treat deleterious effects associated with alcohol consumption and ment or prevention of alcohol-induced flush reaction and provides related benefits. This is accomplished by the com hangover. positions and their administration as provided herein. 0009. In one aspect of the present invention a composition BACKGROUND OF THE INVENTION for the prevention or reduction of deleterious effects associ 0003 Metabolism of alcohol involves a two step enzy ated with alcohol consumption is provided including an effec matic reaction. First, alcohol is oxidized to acetaldehyde by tive amount of each of famotidine and succinic acid and a alcoholdehydrogenase. Second, the acetaldehyde is oxidized pharmaceutically acceptable carrier. The composition is to acetic acid by acetaldehyde dehydrogenase and glu effective at preventing or reducing alcohol-induced flush tathione. Acetic acid is then transported to the muscles and reaction and hangover. The composition is particularly useful adipose tissue where it is further broken down into carbon for Subjects that do not significantly respond to treatments dioxide and water. Thus, the rate at which alcohol is metabo such as the H1 receptor antagonist loratidine or the H2 recep lized to acetic acid depends in part upon the balance of both tor antagonist cemetidine. alcohol dehydrogenase and acetaldehyde dehydrogenase. 10010. In another aspect of the present invention, a method This balance is important because although alcohol is toxic to for preventing or reducing alcohol-induced flush reaction and the body, acetaldehyde is actually more toxic than alcohol. hangover in a human is provided including administering to 0004 Polymorphisms in the acetaldehyde dehydrogenase the human an effective amount of a composition including gene correlate significantly to particular populations, such as famotadine and succinic acid with a pharmaceutically accept those having Asian ancestry and even more significantly to able carrier prior to imbibing in alcohol. Famotidine may be those having Japanese ancestry. These polymorphisms fre provided as the sole histamine receptor antagonist. The quently result in slowed conversion of acetaldehyde to acetic method may be particularly desired for humans that do not acid. Accordingly, without significant slowing of alcohol significantly respond to loratidine and/or cemetidine. dehydrogenase activity, acetaldehyde begins to buildup in the 0011. In another aspect of the present invention a method body. Rapid accumulation of acetaldehyde causes redness in for the prevention or reducing alcohol-induced flush reaction the skin, primarily along the face and limbs. This condition is in a human is provided including administering to the human referred to as alcohol-induced flush reaction, also known as an effective amount of famotidine as a sole histamine receptor Asian flush. antagonist prior to imbibing in alcohol and optionally suc 0005. A combination treatment for controlling alcohol cinic acid. induced flush reaction is proposed in published U.S. patent 0012. In another aspect of the present invention a method application Ser. No. 11/009,559. Specifically, the authors for treating alcohol-induced flush reaction in a human is propose a combined treatment prior to imbibing in alcohol, provided including administering to a human in need thereof the treatment including administering both an H1 receptor an effective amount of famotidine and a pharmaceutically histamine antagonist and a H2 receptor histamine antagonist. acceptable carrier. The proposed H1 receptor antagonists include terfenadine, astemisole and fenoxifene. The proposed H2 receptor antago BRIEF DESCRIPTION OF THE DRAWINGS nists included cimetidine, famotidine, nizatidine and raniti dine. Such treatments do not address the conversion of alco 0013 FIG. 1 is a structural formula of famotidine. hol to acetic acid but instead propose to competitively 0014 FIG. 2 is a structural formula of succinic acid. antagonize H1 and H2 histadine receptors while in circula 0015 FIG. 3A is a structural formula of cimetidine. FIG. tion, which temporarily reduces the appearance of symptoms. 3B is a structural formula of loratidine. However, the proposed treatments suffer from two draw DETAILED DESCRIPTION OF THE INVENTION backs. First, many that suffer from alcohol-induced flush reaction do not respond to many of the proposed antagonists, 0016. The present invention provides methods and com which indicates the antagonists are not interchangeable. Sec positions for the treatment, prevention or amelioration of ond, in some instances temporarily masking symptoms may symptoms associated with consumption of alcohol. In some lead to increased alcohol consumption, which may intensify embodiments, the present invention treats, prevents or deleterious effects once temporary relief ends. reduces hangover. In some embodiments, the present inven 0006 Although alcohol-induced flush reaction is typically tion treats, prevents or reduces symptoms associated with associated with redness that occurs relatively shortly after alcohol-induced flush reaction. The objects of the present consumption of alcohol, the build up of acetaldehyde also invention are accomplished by providing an effective amount US 2012/00221 22 A1 Jan. 26, 2012 of famotidine, Succinic acid, or a combination thereof. which is a component in the citric acid cycle. Esters of Suc Administration preferably occurs prior to imbibing in alco cinic acid are referred to as alkyl Succinates. Succinic acid is hol; however, in some embodiments the treatment is provided commercially available as dietary Supplement. Though non after or during imbibing in alcohol. limiting, it is believed that the addition of succinic acid will 0017. The preferred composition and methods of the accelerate the decomposition of acetaldehyde. This is present invention provide a sole histamine receptor antago believed to be due at least in part to its role in the citric acid nist, famotidine. The term "sole histamine receptor antago cycle. nist” refers to the use of famotidine without inclusion of an 0023 The compositions provided herein, namely famoti dine and/or Succinic acid are administered in an effective additional H1 or H2 receptor antagonist. Famotidine is a amount. The term “effective amount’ as used herein refers to white to pale yellow crystalline compound that is freely the amount of each active ingredient, which provides a ben soluble in glacial acetic acid, slightly soluble in methanol, eficial effect. With respect to famotidine, an effect amount very slightly soluble in water, and practically insoluble in significantly reduces symptoms associated with alcohol-in ethanol. It has a molecular weight of 337.43; an empirical duced flush reaction, such as decreased redness that is easily formula of CHN.O.S., and its structural formula is pro observable compared to no treatment or in Some instances vided as FIG. 1. The chemical name for famotidine is N'- compared
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