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(12) Patent Application Publication (10) Pub. No.: US 2015/0202199 A1 Bear Et Al US 20150202199A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0202199 A1 Bear et al. (43) Pub. Date: Jul. 23, 2015 (54) TREATMENTS FOR DEPRESSION AND A63L/343 (2006.01) OTHERDISEASES WITH A LOW DOSE A63/37 (2006.01) AGENT A613 L/428 (2006.01) (71) Applicant: PharmoRx Therapeutics, Inc., A6II 45/06 (2006.01) Westborough, MA (US) A63L/38 (2006.01) (72) Inventors:nVentors: DavidJaVIC IV.M. Bear,Sear, Weston,Weston, MA (US) (52) U.S. Cl. Robert M. Kessler, Nashville, TN (US) CPC ............... A61K 31/485 (2013.01); A61K 45/06 (2013.01); A61 K3I/496 (2013.01); A61 K (21) Appl. No.: 14/639,797 31/381 (2013.01); A61 K3I/343 (2013.01); 22) Filed: Mar 5, 2015 A6 IK3I/137 (2013.01); A61 K3I/428 (22) Filed: ar. 5, (2013.01); A61 K3I/135 (2013.01) Related U.S. Application Data (63) Continuation-in-part of application No. 14/410,551, (57) ABSTRACT filed as application No. PCT/US14/13874 on Jan. 30, 2014. The present invention relates to improved compositions and (60) Provisional application No. 61/758551, filed on Jan. methods for the treatment or prevention of various diseases, 30, 2013, provisional application No. 61/814,476, filed on Apr. 22, 2013. including forms of depression, including, for example, break through depression and treatment-refractory depression, and Publication Classification other mood disorders, as well as Parkinson's disease, bipolar (51) Int. Cl disorder, bipolar disorder, attention deficit disorder (ADHD), A. iK I/2485 (2006.01) Restless Leg Syndrome (RLS), and obesity. In some embodi A6 IK3I/496 (2006.01) ments, the compositions and methods comprise low dose A6 IK3I/35 (2006.01) maltrexone or related opioid antagonists. Patent Application Publication Jul. 23, 2015 Sheet 1 of 6 US 2015/0202199 A1 FIGURE 1A -- S:888 x88; is: & | 8. 3-W-SWs 3. 8. 's------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Patent Application Publication Jul. 23, 2015 Sheet 2 of 6 US 2015/0202199 A1 FIGURE 2A 3. & : s: {x : Patent Application Publication Jul. 23, 2015 Sheet 3 of 6 US 2015/0202199 A1 FIGURE 3A : Patent Application Publication Jul. 23, 2015 Sheet 4 of 6 US 2015/0202199 A1 FIGURE 4A VARSS Secres ever fire Patent Application Publication Jul. 23, 2015 Sheet 5 of 6 US 2015/0202199 A1 FGURE SA {{i-8 Seges xerie 3. 3. 83. ::::::::::::s: Patent Application Publication Jul. 23, 2015 Sheet 6 of 6 US 2015/0202199 A1 FIGURE 6A & US 2015/0202199 A1 Jul. 23, 2015 TREATMENTS FOR DEPRESSION AND weight is at least 20% higher than it should be, he or she is OTHER DISEASES WITH A LOW DOSE considered obese. Obesity is linked to a panoply of diseases, AGENT including coronary heart disease, type 2 diabetes, cancers (e.g., endometrial, breast, and colon), hypertension, dyslipi PRIORITY demia, stroke, liver and gallbladder disease, sleep apnea and 0001. The present application is a continuation-in-part of respiratory problems, osteoarthritis, and gynecological prob U.S. patent application Ser. No. 14/410,551, which, on Dec. lems, among others. 22, 2014, entered the U.S. National Stage of International 0007 Unfortunately, sufficient treatment for these disor Patent Application No. PCT/US2014/013874, filed Jan. 30, ders has proven elusive. For instance, in the context of depres 2014, which claims priority to U.S. Provisional Application Sion, while certain pharmaceuticals have proven somewhat No. 61/758,551, filed on Jan. 30, 2013 and U.S. Provisional Successful, medical practitioners face the challenge of unpre Application No. 61/814,476, filed on Apr. 22, 2013, the con dictable responses and eventual loss of effect, necessitating tents of which are herein incorporated by reference in their constant evaluation of treatments and, often, changes in treat entireties. The present application is related to U.S. patent ment regimens. Further, anti-depression pharmaceuticals are application Ser. No. 12/603,235, filed Oct. 21, 2009 and U.S. often characterized by unpleasant side effects. patent application Ser. No. 13/758,569, filed Feb. 4, 2013, the 0008. Therefore, there remains a need for therapies that contents of which are incorporated by reference in their are useful for treating various mental illnesses and obesity. entireties. BRIEF DESCRIPTION OF THE INVENTION FIELD OF THE INVENTION 0009. Accordingly, the present invention relates to improved compositions and methods for the treatment or 0002 The present invention relates to compositions and prevention of various forms of depression and/or mood dis methods that are useful in treating various forms of depres orders, including, for example, breakthrough depression and sion and other disorders. treatment-refractory depression, and other mood disorders as BACKGROUND well as other ADHD, Parkinson's disease, and obesity, among others. 0003 Mental illnesses and obesity are increasing preva 0010. In one aspect, the present invention provides a lent disorders in the modern world and require improved method of preventing or treating breakthrough depression in treatments to maximize patient quality of life and reduce a patient in need thereof comprising administering an effec health care costs. tive amount of low dose naltrexone or related opioid antago 0004 For instance, depression refers to a serious medical nist. illness that affects one’s thoughts, feelings, behavior, mood 0011. In another aspect, the present invention provides a and physical health. Major depression, also referred to as method of preventing or treating treatment-refractory depres clinical depression, major depressive illness, major affective sion in a patient in need thereof comprising administering an disorder and unipolar mood disorder, may involve some com effective amount of low dose naltrexone or related opioid bination of the following symptoms: depressed mood (Sad antagonist. ness), poor concentration, insomnia, fatigue, appetite distur 0012. In a further aspect, the present invention provides a bances, excessive guilt and thoughts of Suicide. Left method of preventing or treating breakthrough depression in untreated, depression can lead to serious impairment in daily a patient in need thereof comprising administering an effec functioning and even Suicide. Suicide is the tenth leading tive amount of low dose naltrexone or related opioid antago cause of death in the U.S. Researchers believe that more than nist in combination with an effective amount of one or more one-half of people who die by Suicide are experiencing of a dopamine active anti-depressantagent, a dopamine active depression. Each year depression affects 5-8 percent of adults augmenting agent, a serotonin-norepinephrine reuptake in the United States. Therefore, about 25 million Americans inhibitor (SNRI), and a selective serotonin re-uptake inhibitor will have an episode of major depression this year alone. (SSRI). Without treatment, the frequency and severity of depression 0013. In another aspect, the present invention provides a symptoms tend to increase over time. method of preventing or treating treatment-refractory depres 0005. Furthermore, attention deficit hyperactivity disor sion in a patient in need thereof comprising administering an der (ADHD) is one of the most common childhood disorders effective amount of low dose naltrexone or related opioid and can continue through adolescence and adulthood. Symp antagonist in combination with an effective amount of one or toms include difficulty staying focused and paying attention, more of a dopamine active anti-depressantagent, a dopamine difficulty controlling behavior, and hyperactivity (over-activ active augmenting agent, a serotonin-norepinephrine ity). Parkinson's disease is a degenerative disorder of the reuptake inhibitor (SNRI), and a selective serotonin re-uptake central nervous system with marked motor symptoms linked, inhibitor (SSRI). in part, to the death of dopamine-generating cells. Common 0014. In another aspect, the present invention provides a symptoms of this disorder are movement-related, including method of preventing or treating one or more of depression, shaking, rigidity, slowness of movement and difficulty with Parkinson's disease, attention deficit disorder (ADHD). Rest walking and gait. Behavioral problems and dementia are also less Leg Syndrome (RLS), and obesity comprising adminis common, particularly in late stage disease. Bipolar disorder tering an effective amount of low dose naltrexone or related describes a brain disorder that causes unusual shifts in mood, opioidantagonist in combination with an effective amount of energy, activity levels, and the ability to carry out day-to-day another agent described herein. tasks. 0015 The details of the invention are set forth in the 0006 Obesity is a disorder marked by excessive body fat accompanying description below. Although methods and that negatively affects a patients health. If a person’s body materials similar or equivalent to those described herein can US 2015/0202199 A1 Jul. 23, 2015 be used in the practice or testing of the present invention, 0025. In a further aspect, the present invention provides a illustrative methods and materials are now described. Other method of preventing or treating breakthrough depression in features, objects, and advantages of the invention will be a patient in need thereof comprising administering an effec apparent from the description and from the claims. In the
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