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(12) Patent Application Publication (48) Pub US 200900 12161A9 (19) United States (10) Pub. No.: US 2009/0012161 A9 (12) Patent Application Publication (48) Pub. Date: Jan. 8, 2009 Mehlburger et al. CORRECTED PUBLICATION (54) PHARMACEUTICAL COMPOSITION Prior Publication Data COMPRISING A BETA-3-ADRENOCEPTOR AGONST AND A SEROTONIN AND/OR (15) Correction of US 2005/0261369 A1 Nov. 24, 2005 NOREPINEPHRINE REUPTAKE INHIBITOR See (63) Related U.S. Application Data. (75) Inventors: Ludwig Mehlburger, Bingen (DE); (65) US 2005/0261369 A1 Nov. 24, 2005 Martin Michel, Amsterdam (NL); Marion Wienrich, Weiterstadt (DE); Related U.S. Application Data Ursula Ebinger, Boonton Township, NJ (63) Continuation of application No. PCT/EP2003/ (US) O12225, filed on Nov. 3, 2003. Correspondence Address: (30) Foreign Application Priority Data MICHAEL P. MORRIS BOEHRINGERINGELHEMI USA Nov. 27, 2002 (EP)........................................... O2O26546 CORPORATION Publication Classification 900 RIDGEBURY ROAD P. O. BOX 368 (51) Int. Cl. RIDGEFIELD, CT 06877-0368 (US) A6II 3L/24 (2006.01) A 6LX 3L/95 (2006.01) (73) Assignee: Boehringer Ingelheim International A6II 3L/37 (2006.01) GmbH, Ingelheim (DE) (52) U.S. Cl. ........................... 514/540: 514/567; 514/649 (57) ABSTRACT (21) Appl. No.: 11/136,165 This invention describes a new combination for the treatment of bladder function disorders which comprises a serotonin and/or norepinephrine-reuptake inhibitor and a beta-3- (22) Filed: May 24, 2005 adrenoceptor agonist. US 2009/0012161 A9 Jan. 8, 2009 PHARMACEUTICAL COMPOSITION elevated intraabdominal pressure. This may occur for COMPRISING A BETA-3-ADRENOCEPTOR example when lifting, coughing, Sneezing, running while at AGONST AND A SEROTONIN AND/OR the same time there is no detrusor activity. Loss of urine takes NOREPINEPHRINE REUPTAKE INHIBITOR place as the result of a variable combination of an insuffi ciency of the sphincter muscles of the bladder and the pelvic 0001. This invention describes a new active substance floor as well as anatomical defects in the Suspensory appara combination for the treatment of functional bladder prob tus. As a result the closure pressure of the urethra is too low lems, particularly mixed incontinence. According to the and incontinence results. Pure stress incontinence often invention a combination of pharmaceutically active Sub occurs in women, particularly if they have given birth. In men, stances comprising at least one beta-3-adrenoceptor agonist this form of urinary incontinence is usually only observed and at least one serotonin and/or norepinephrine reuptake after prostatectomies or other Surgical interventions on the inhibitor is proposed. Small pelvis. PRIOR ART 0009. In so-called mixed incontinence patients suffer from symptoms of both stress incontinence and urge incontinence. 0002 The incidence of urinary incontinence is constantly Once again, it is mainly women who are affected. increasing as a result of changes in the ageing statistics. Nevertheless those affected are for the most part still 0010 For the treatment of the various forms of urinary untreated or inadequately treated. Apart from the medical bladderfunctional disorders, particularly stress incontinence, consequences such as chronic infections of the urinary pas urge incontinence, mixed incontinence or overactive bladder, sages, urinary incontinence for those affected is associated various approaches are available. with a high psychological burden of Suffering. It is estimated 0011 For treating urge incontinence the WHO recom that 100 million older people are affected by urinary incon mends treatment with anticholinergics (antimuscarinics). tinence. However, their use is limited because they are only moder 0003. The lower urinary tract consists of the bladder, the ately effective and particularly because they have serious side urethra, the associated muscles and the ligaments of the Sus effects such as dryness of the mouth, accommodation disor pensory apparatus. The purpose of the bladder is to store urine ders, constipation and central nervous effects (dizziness, and evacuated it. The important factors for performing the fatigue, confusion). storage function are not only the relaxation of the bladder 0012. There are, in particular, conservative and surgical muscle (detrusor muscle), but also the closure mechanisms options for treating stress incontinence. Hitherto, no gener provided by the neck of the bladder, the smooth muscle of the ally applicable drug therapy has been established. Alpha urethra and also the cross-striated muscle of the urethra and agonists such as pseudoephedrine and phenylpropanolamine the pelvic floor. During the emptying of the bladder (mictu show only a very modest effect in the treatment of low-grade rition) the detrusor muscle contracts while the urethra and stress incontinence. A disadvantage is that they have no selec pelvic floor relax and the sphincter muscle of the bladder tivity for the urethral muscles and have numerous side effects opens. These operations require complex control by the para Such as hypertension, tachycardia, arrhythmia, sleep disor sympathetic, sympathetic and somatic nervous system. ders, headaches and tremors. 0004 Functional bladder problems are a heterogeneous 0013 The treatment of mixed incontinence is a controver group of disorders which differ in their aetiology, diagnosis sial Subject of discussion and encompasses combinations of and therapy. invasive procedures for treating the stress incontinence com 0005. In the standardising recommendations of the Inter ponent and drug therapies for treating the urge incontinence national Continence Society (ICS) urinary incontinence is component. defined as involuntary loss of urine which is objectively 0014 Since the mid-1995s it has been reported that selec detectable and constitutes a social and hygiene problem. Gen tive beta-3-adrenoceptor-agonists are also promising in the erally, urinary incontinence only occurs when there is an treatment of urinary incontinence (EP 0958 835). As the unintentional increase in the pressure in the bladder during stimulation of beta-3-receptors is of exceptional importance the storage phase. This can happen as a result of unrestricted for the relaxation of the detrusor muscle, the use of selective contractions of the detrusor muscle (urge incontinence) or beta-3-adrenoceptors in patients with urge incontinence failure of the urethral closure mechanism (stress inconti should result in the reduction or prevention of involuntary nence). detrusor contractions during the urine storage phase. Tests 0006. According to the ICS definition, the term overactive with beta-3-adrenoceptor agonists promise a high efficacy bladder (OAB) is used when there is an irresistible imperative while being well tolerated. In addition, their activity should need to urinate, which may or may not be associated with urge be restricted to the storage phase of the bladder and unim incontinence, usually with increased frequency of micturition peded emptying of the bladder should be guaranteed without and nocturnalurination. Pathophysiologically, this complaint any build-up of urine residues. may be based on involuntary contractions during the filling 0015 Currently, clinical trials for the treatment of stress phase, the cause of which may be neurogenic or non-neuro incontinence are being conducted on those Substances which genic (idiopathic) by nature. selectively inhibit serotonin and/or norepinephrine reuptake from the synaptic gap into the nerve cells. These substances 0007 Urge incontinence is characterised by an irresistible are known as selective serotonin/norepinephrine reuptake need to urinate and involuntary loss of urine. inhibitors and lead to a prolonging and reinforcement of the 0008 Stress incontinence is characterised by the involun effect of serotonin (5-hydroxy-tryptamine=5-HT), and/or tary loss of urine which generally occurs at moments of nor-adrenalin (NA). Through a complex mechanism of activ US 2009/0012161 A9 Jan. 8, 2009 ity, selective serotonin/norepinephrine reuptake inhibitors are acid, ethaneSulphonic acid, fumaric acid, gluconic acid, able to stimulate the activity of the pudendal nerve, promote glutamic acid, hydrobromic acid, hydrochloric acid, hydri the contraction of the cross-striated sphincter muscle of the odic acid, isethionic acid, lactic acid, maleic acid, malic acid, bladder and thereby maintain continence. Phase III clinical mandelic acid, methanesulphonic acid (mesylate), mucinic trials have shown in the meantime that by using a selective acid, nitric acid, oxalic acid, pamoic acid, pantothenic acid, serotonin/norepinephrine reuptake inhibitor it is possible for phosphoric acid, Succinic acid, Sulphuric acid, tartaric acid, the first time to provide an effective drug therapy for stress p-toluenesulphonic acid and the like. Examples of pharma ceutically acceptable salts include, without being restricted incontinence. thereto, acetate, benzoate, hydroxybutyrate, bisulphate, 0016. There are also only limited therapies available for bisulphite, bromide, butyn-1,4-dioate, caproate, chloride, treating overactive bladder. The less well established forms of chlorobenzoate, citrate, dihydrogenphosphate, dinitroben treatment also include drugs containing antimuscarinics as Zoate, fumarate, glycollate, heptanoate, hexyne-1,6-dioate, the active Substance. hydroxybenzoate, iodide, lactate, maleate, malonate, mande late, metaphosphate, methaneSulphonate, methoxybenzoate, PROBLEM OF THE INVENTION methylbenzoate, monohydrogenphosphate, naphthalene-1-
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