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(12) Patent Application Publication (10) Pub. No.: US 2009/0054381 A1 Letts (43) Pub US 2009.0054381A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0054381 A1 Letts (43) Pub. Date: Feb. 26, 2009 (54) METHODS FORTREATING RESPIRATORY Related U.S. Application Data DSORDERS (60) Provisional application No. 60/722,961, filed on Oct. 4, 2005. (75) Inventor: L. Gordon Letts, Dover, MA (US) Publication Classification Correspondence Address: (51) Int. Cl. WILMERHALEANTROMED A63L/50 (2006.01) 1875 PENNSYLVANIAAVE, NW A6II 3/56 (2006.01) WASHINGTON, DC 20006 (US) A6IP 9/00 (2006.01) A6IP II/00 (2006.01) (73) Assignee: NitroMed, Inc., Lexington, MA (52) U.S. Cl. ......................................... 514/171; 514/247 (US) (57) ABSTRACT The invention provides methods for treating respiratory dis (21) Appl. No.: 12/088,922 orders in a patient in need thereof comprising administering an effective amount of (i) at least one hydralazine compound (22) PCT Filed: Oct. 4, 2006 or a pharmaceutically acceptable salt thereof, (ii) isosorbide dinitrate and/or isosorbide mononitrate, and (iii) optionally at (86). PCT No.: PCT/USO6/38965 least one therapeutic agent. The hydralazine compound may be hydralazine hydrochloride. The respiratory disorders may S371 (c)(1), be chronic obstructive pulmonary disease, pulmonary hyper (2), (4) Date: Jul. 11, 2008 tension, emphysema, asthma, cystic fibrosis and bronchitis. US 2009/0054381 A1 Feb. 26, 2009 METHODS FOR TREATING RESPRATORY obstructive pulmonary disease, pulmonary hypertension, DISORDERS emphysema, asthma, cystic fibrosis and bronchitis. In these embodiments of the invention, the methods can involve (i) RELATED APPLICATIONS administering the hydralazine compound or a pharmaceuti 0001. This application claims priority under 35 USC S 119 cally acceptable salt thereof, and at least one of isosorbide to U.S. application Ser. No. 60/722,961 filed Oct. 4, 2005, the dinitrate and/or isosorbide mononitrate, or (ii) administering disclosure of which is incorporated by reference herein in its the hydralazine compound or a pharmaceutically acceptable entirety. salt thereof, at least one of isosorbide dinitrate and/or isosor bide mononitrate, and therapeutic agents. The hydralazine FIELD OF THE INVENTION compound group, isosorbide dinitrate and/or isosorbide mononitrate and/or therapeutic agents can be administered 0002 The invention provides methods for treating respi separately or as components of the same composition in one ratory disorders in a patient in need thereof comprising or more pharmaceutically acceptable carriers. administering an effective amount of (i) at least one hydrala 0005. The invention provides methods for treating respi Zine compound or a pharmaceutically acceptable salt thereof, ratory disorders in a patient in need thereof comprising (ii) isosorbide dinitrate and/or isosorbide mononitrate, and administering to the patient an effective amount of hydrala (iii) optionally at least one therapeutic agent. The hydralazine zine hydrochloride and isosorbide dinitrate. The methods can compound may be hydralazine hydrochloride. The respira optionally further comprise the administration of at least one tory disorders may be chronic obstructive pulmonary disease, therapeutic agent, such as, for example, antimicrobial com pulmonary hypertension, emphysema, asthma, cystic fibrosis pounds, aldosterone antagonists, alpha-adrenergic receptor and bronchitis. antagonists, f-adrenergic agonists, anti-allergic compounds, antidiabetic compounds, anti-hyperlipidemic drugs, antitus BACKGROUND OF THE INVENTION sive compounds, angiotensin II antagonists, angiotensin-con 0003. The incidence and prevalence of respiratory dis Verting enzyme (ACE) inhibitors, antioxidants, antithrom eases and disorders has increased over the past decade. Also botic and vasodilator drugs, B-adrenergic antagonists, there has been reported an alarming increase in mortality bronchodilators, calcium channel blockers, diuretics, endot associated with respiratory disorders. Current methods for helin antagonists, expectorants, hydralazine compounds, H. treating these disorders are not optimal, as they require fre receptor antagonists, neutral endopeptidase inhibitors, non quent and repeated administration of the appropriate drugs, steroidal antiinflammatory compounds (NSAIDs), phos resulting in issues of compliance. There is a need in the art for phodiesterase inhibitors, potassium channel blockers, plate new and more effective compositions and methods for treat let reducing agents, proton pump inhibitors, renin inhibitors, ingrespiratory disorders. The invention is directed to these, as selective cyclooxygenase-2 (COX-2) inhibitors, steroids, and well as other, important ends. combinations of two or more thereof. In another embodiment the at least one therapeutic agent is selected from the group SUMMARY OF THE INVENTION consisting of antimicrobial compounds, B-adrenergic ago nist, an anti-allergic compound, an antitussive compound, an 0004. The invention provides methods for treating respi antioxidant, a bronchodilator, an expectorant, a nonsteroidal ratory disorders in a patient in need thereof comprising antiinflammatory compound (NSAIDs), a phosphodiesterase administering to the patient an effective amount of (i) a inhibitor, a selective cyclooxygenase-2 (COX-2) inhibitor hydralazine compound or a pharmaceutically acceptable salt and a steroid. In one embodiment the respiratory disorder is thereof, (ii) isosorbide dinitrate and/or isosorbide mononi chronic obstructive pulmonary disease, pulmonary hyperten trate, and (iii) optionally at least one therapeutic agent. In one Sion, emphysema, asthma, cystic fibrosis and bronchitis. In embodiment the therapeutic agents include, but are not lim these embodiments of the invention, the methods can involve ited to, antimicrobial compounds, aldosterone antagonists, (i) administering the hydralazine hydrochloride and isosor cc-adrenergic receptor antagonists, f-adrenergic agonists, bide dinitrate, or (ii) administering the hydralazine hydro anti-allergic compounds, antidiabetic compounds, anti-hy chloride, isosorbide dinitrate and therapeutic agents. The perlipidemic drugs, antitussive compounds, angiotensin II hydralazine hydrochloride, isosorbide dinitrate and/or thera antagonists, angiotensin-converting enzyme (ACE) inhibi peutic agents can be administered separately or as compo tors, antioxidants, antithrombotic and vasodilator drugs, nents of the same composition in one or more pharmaceuti B-adrenergic antagonists, bronchodilators, calcium channel cally acceptable carriers. blockers, diuretics, endothelin antagonists, expectorants, hydralazine compounds, H receptor antagonists, neutral 0006. These and other aspects of the invention are endopeptidase inhibitors, nonsteroidal antiinflammatory described in detail herein. compounds (NSAIDs), phosphodiesterase inhibitors, potas sium channel blockers, platelet reducing agents, proton pump DETAILED DESCRIPTION OF THE INVENTION inhibitors, renin inhibitors, selective cyclooxygenase-2 0007 As used throughout the disclosure, the following (COX-2) inhibitors, steroids, and combinations of two or terms, unless otherwise indicated, shall be understood to have more thereof. In another embodiment the at least one thera the following meanings. peutic agent is selected from the group consisting of an anti 0008 “Patient” refers to animals, preferably mammals, microbial compound, a B-adrenergic agonist, an anti-allergic most preferably humans, and includes males and females. compound, an antitussive compound, an antioxidant, a bron 0009 “Effective amount refers to the amount of the com chodilator, an expectorant, a nonsteroidal antiinflammatory pound and/or composition that is necessary to achieve its compound (NSAIDs), a phosphodiesterase inhibitor, a selec intended purpose. tive cyclooxygenase-2 (COX-2) inhibitor and a steroid. In 0010) “Respiratory disorder” refers to any respiratory dis another embodiment the respiratory disorders is chronic ease or respiratory disorder. Such as, for example, chronic US 2009/0054381 A1 Feb. 26, 2009 obstructive pulmonary disease, pulmonary hypertension, tives thereof, peptides, including di- and tri-peptides, and emphysema, asthma, cystic fibrosis, bronchitis, acute pulmo antibodies to ACE which intervene in the renin-angiotensin nary vasoconstriction, pneumonia, traumatic injury, aspira system by inhibiting the activity of ACE thereby reducing or tion or inhalation injury, fat embolism in the lung, acidosis, eliminating the formation of the pressor Substance angio inflammation of the lung, adult respiratory distress syndrome, tensin II. acute pulmonary edema, acute mountain sickness, post car 0016 “Angiotensin II antagonists' refers to compounds diac Surgery, pulmonary hypertension, persistent pulmonary which interfere with the function, synthesis or catabolism of hypertension of the newborn, perinatal aspiration syndrome, angiotensin II. Angiotensin II antagonists include peptide hyaline membrane disease, acute pulmonary thromboembo compounds and non-peptide compounds, including, but not lism, heparin-protamine reactions, sepsis, status asthmaticus, limited to, angiotensin II antagonists, angiotensin II receptor hypoxia, bronchopulmonary dysplasia, chronic pulmonary antagonists, agents that activate the catabolism of angiotensin thromboembolism, idiopathic pulmonary hypertension, pri II, and agents that prevent the synthesis of angiotensin I from mary pulmonary hypertension, chronic hypoxia, Sarcoidosis, angiotensin II. The renin-angiotensin System is involved in
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