US 20140094438A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0094438 A1 Mitchell (43) Pub. Date: Apr. 3, 2014 (54) COMPOSITIONS AND METHODS FOR THE A63/37 (2006.01) TREATMENT OF PAN A63L/25 (2006.01) A613 L/4402 (2006.01) (71) Applicant: GM Pharmaceuticals, Inc., Arlington, A613 L/495 (2006.01) TX (US) A63L/09 (2006.01) A63L/045 (2006.01) (72) Inventor: Odes W. Mitchell, Arlington, TX (US) A613 L/60 (2006.01) A 6LX3 L/505 (2006.01) (73) Assignee: GM Pharmaceuticals, Inc., Arlington, TX (US (52) U.S. Cl. (US) CPC ............... A61 K3I/616 (2013.01); A61K3I/60 (2013.01); A61 K3I/522 (2013.01); A61 K (21) Appl. No.: 14/043,722 31/194 (2013.01); A61K 31/137 (2013.01); 1-1. A6 IK3I/505 (2013.01); A61 K3I/4402 (22)22) FileFiled: Oct.Cl. 1, 2013 (2013.01); A61 K3I/495 (2013.01);s A61 K Related U.S. Application Data 3 1/09 (2013.01); A61K3I/045 (2013.01); A6 IK31/125 (2013.01) (60) Provisional application No. 61/708,533, filed on Oct. USPC ....... 514/161; 562/471; 560/193: 514/263.31 1, 2012. (57) ABSTRACT Publication Classification The claimed invention relates to compositions that may be in (51) Int. Cl. a form of a liquid, Solid, gel, cream or gel capsule comprising A6 IK3I/66 (2006.01) an analgesic, and methods for administering these composi A6 IK3I/522 (2006.01) tions for treatment of patients suffering from various forms of A6 IK3I/94 (2006.01) pain. US 2014/0094438 A1 Apr. 3, 2014 COMPOSITIONS AND METHODS FOR THE 0009. In another embodiment of the present invention, the TREATMENT OF PAIN compositions may comprise an analgesic/antipyretic from one or more of the group consisting of acetaminophen, CROSS-REFERENCES TO RELATED buprenorphine, butorphanol, codeine, dextropropoxyphene. APPLICATIONS dihydrocodeine, fentanyl, diamorphine (Heroin), hydroc odone, hydromorphone, ketobemidone, morphine, nalbu 0001. This Application claims the benefit under 35 U.S.C. phine, oxycodone, oxymorphone, pentazocine, pethidine, S119(e) of U.S. Provisional Patent Application No. 61/708, tramadol, diflunisal, ethenzamide, aminophenaZone, 533 filed Oct. 1, 2012, which is incorporated herein by refer metamizole, phenazone, phenacetin, Ziconotide, tetrahydro ence in its entirety as if fully set forth herein. cannabinol, acetylsalicylic acid, choline salicylate, magne sium salicylate, sodium salicylate, ibuprofen, naproxen and FIELD OF THE INVENTION ketoprofen. 0002 The present invention relates to compositions com 0010. In another embodiment of the present invention, the prising an analgesic that may be in the form of a liquid, gel. compositions may comprise an analgesic adjunct from one or cream, tablet or gel capsules, and methods for administering more of the group consisting of S (+)-ketamine, metoclopra these compositions for treatment of patients suffering from mide, ciramadol, sulfentanil, caffeine and remifentanil. various forms of pain. (0011. The compositions of the present invention may be administered to the patient for oral use and may be in the form BACKGROUND OF THE INVENTION of an elixir, syrup and/or suspension according to an indi 0003 Pain is an unpleasant sensation with a wide range in vidual patient's preferences. In another embodiment of the severity that can be localized or prevalent throughout the present invention, the compositions may further comprise a body. Pain is affected by nerve stimulation that carries flavorant. impulses to the brain and is a symptom of an underlying 0012. In certain embodiments of the invention, the com disease, disorder, or physical injury. positions of the claimed invention may be administered to the 0004. It is estimated that 100 million Americans currently patient as a tablet, gel, cream or gel capsules. suffer with pain. Clinical complaints due to pain come in 0013. In another embodiment of the present invention, the many varieties. Such complaints may be due to such ailments compositions may be substantially free of other added active as arthritis, back pain, neuropathy, or a headache. ingredients. The other added active ingredient may comprise 0005. A headache, also known as cephalalgia, ranks an antihistamine, such as one or more of the group consisting amongst the most common clinical pain complaints and can of diphenhydramine, cyproheptadine hydrochloride, bro be caused from a wide variety of physiological effects. Such mpheneramine, hydroxyzine, chloropheniramine, pyril causes range from hormonal changes, muscle tension in the amine maleate, pyrilamine tannate, acepromazine, back of the neck, or from dehydration. Because headaches aceprometazine, alimemazine, alimemazine tartrate, amoxy come in many forms, they may be treated or prevented by dramine camsilate, antazoline chlorhydrate, antazoline mesi various methods. These methods may include maintaining a late, antazoline phosphate, astemizole, azatadine dimaleate, healthy lifestyle, reducing stress or making use of various azelastine hydrochloride, bamipine hydrochloride, benac medications. Such medications can be antianxiety drugs, tyzine hydrochloride, bretylium tosilate, bromazine hydro antidepressants or nonsteroidal anti-inflammatories chloride, brompheniramine maleate, buclizine dihydrochlo (NSAIDs). However, when these drugs are ineffective or not ride, bufexamac, carbinoxamine maleate acid, cetiedil citrate, possible to use due to allergic reactions, other drug combina cetirizine dihydrochloride, chlorcyclizine hydrochloride, tions may be prescribed. chlorphenamine maleate, chlorphenoxamine hydrochloride, chlorprothixene hydrochloride, cinnarizine, clemastine SUMMARY OF THE INVENTION fumarate, clemizole hexachlorophenate, clemizole penicil line, clemizole undecylenate, clocinizine dihydrochloride. 0006 An embodiment of the invention is directed to a clofedanol, clofenetamine hydrochloride, cyclizine hydro composition comprising an analgesic/antipyretic compound. chloride, dexchlorpheniramine maleate, di (acefylline) In certain embodiments of the invention, the composition diphenhydramine, difencloxazine, dimelazine hydrochlo further comprises an analgesic adjunct or an antihistamine. ride, dimenhydrinate, dimethoxanate hydrochloride, cimeto Embodiments of the invention provide for the composition as tiazine mesilate, diphenhydramine hydrochloride, diphenhy a liquid, solid, gel/cream, tablet or gel capsule. dramine mesilate, diphenylpyraline hydrochloride, diprocqualone camsilate, dixyrazine, doxylamine succinate, DETAILED DESCRIPTION OF EXEMPLARY eprozinol dihydrochloride, etodroxizine dimaleate, etyben EMBODIMENTS Zatropine bromhydrate, etybenzatropine hydrochloride, 0007. The present invention provides compositions and etymemazine hydrochloride, fenethazine hydrochloride, methods of using the compositions for the therapeutic treat fenoxazoline hydrochloride, fenpentadiol, flunarizine hydro ment of pain. Specifically, the present invention comprises a chloride, flupentixol decanoate, flupentixol dihydrochloride, composition of an analgesic/antipyretic either with or without histapyrrodine hydrochloride, hydroxyzine dihydrochloride, an analgesic adjunct and either with or without an antihista hydroxyzine embonate, indoramine hydrochloride, mine, where said composition is in the form of a liquid, Solid isothipendyl hydrochloride, ketotifene fumarate, levocabas or gel/cream. tine hydrochloride, levomepromazine, levomepromazine 0008. As used herein, the term “analgesic/antipyretic' hydrochloride, levomepromazine embonate, levomepro refers to a compound or compounds that are effective in mazine maleate, loratadine, maprotiline hydrochloride, treating pain (analgesic) and are also effective at reducing maprotiline mesilate, maprotiline resinate, meclozine hydro fever (antipyretic). chloride, mecysteine hydrochloride, medifoxamine fuma US 2014/0094438 A1 Apr. 3, 2014 rate, mefenidramium metilsulfate, mepyramine maleate, those skilled in the art from this detailed description. The meduitazine, methaqualone, methdilazine hydrochloride, invention will be further illustrated by the following non metixene hydrochloride, mizolastine, moxisylyte hydrochlo limiting examples. ride, niaprazine, orphenadrine hydrochloride, oxaflumazine disuccinate, oxatomide, oxolamine benzilate, oxolamine cit WORKING EXAMPLES rate, oXomemazine, oXomemazine hydrochloride, parathiaz ine teoclate, perimetazine, pheniramine maleate, phenoxy 0022. The products listed below exemplify certain of the benzamine hydrochloride, phenyltoloxamine, products in accordance with the claimed invention. In the phenyltoloxamine citrate, pimethixene, pipotiazine, piprete products listed below, only the primary active ingredients, col dihydrochloride, pizotifene malate, prednazoline, profe i.e., analgesic/antipyretic, analgesic adjunct or antihistamine namine hydrochloride, promethazine, promethazine hydro is listed. It would be apparent to one of ordinary skill in the art chloride, promethazine embonate, promethazine that the listed product formulations could contain inertingre polyvinylbenzene-metacrylate, propiomazine, terfenadine, dients such as buffers, fillers and other inactive ingredients. thenalidine tartrate, thenyldiamine hydrochloride, thiazina mium metilsulfate, thonzylamine hydrochloride, tripelen Product 1 namine hydrochloride, triprolidine hydrochloride, and tyma (0023 Choline Salicylate 870 mg Zoline hydrochloride, and combinations thereof. (0024 Caffeine 65 mg 0014. In another embodiment, the compositions of the present invention may comprise one or more of about 1 mg to Product 2 1500 mg of an analgesic/antipyretic, 1 mg