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(12) Patent Application Publication (10) Pub. No.: US 2008/0008748A1 Beyreuther Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2008/0008748A1 Beyreuther Et Al US 200800O8748A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0008748A1 Beyreuther et al. (43) Pub. Date: Jan. 10, 2008 (54) METHOD FOR TREATING PAIN USING A (30) Foreign Application Priority Data SUBSTITUTED 2-AMNOTETRALIN COMPOUND Jun. 22, 2006 (EP).............................. EP O6 O12 815.4 (76) Inventors: Bettina Beyreuther, Dusseldorf (DE); Publication Classification Dieter Scheller, Neuss (DE); Joachim (51) Int. Cl. Freitag, Nurtingen (DE); Josephe A6II 3L/38 (2006.01) Bianchine, Potomac, MD (US) A6II 3L/439 (2006.01) A 6LX 9/70 (2006.01) A6IP 25/04 (2006.01) Correspondence Address: (52) U.S. Cl. ........................... 424/449; 514/289: 514/438 HARNESS, DICKEY, & PIERCE, P.L.C 7700 BONHOMME, STE 400 (57) ABSTRACT ST. LOUIS MO 63105 US 9 (US) A method for treating pain, particularly non-inflammatory musculoskeletal pain Such as fibromyalgia, myofascial pain (21) Appl. No.: 11/764,907 or back pain, in a subject comprises administering to the Subject a substituted 2-aminotetralin compound as defined (22) Filed: Jun. 19, 2007 herein, illustratively rotigotine. vehicle 0.3 mg/kg 1 mg/kg 3 mg/kg rotigotine 100 80 2O - 10-15 time after formalin injection (min) Patent Application Publication Jan. 10, 2008 Sheet 1 of 2 US 2008/0008748A1 vehicle 0.3 mg/kg E 1 mg/kg 3 mg/kg rotigotine 100 6 O 4. O 2 O 10-15 15-20 20-25 25-30 time after formalin injection (min) Fig. 1 vehicle 0.3 mg/kg 1 mg/kg 3 mg/kg rotigotine 300 250 200 15 O 1 O O 5 O O-5 10-30 time after formalin injection (min) Fig. 2 Patent Application Publication Jan. 10, 2008 Sheet 2 of 2 US 2008/0008748A1 30 20 10 rotigotine 0.3 mg/kg rotigotine 1 mg/kg O rotigotine 3 mg/kg s metamizol, 2 mg/kg PBS Fig. 3 rotigotine 1 mg/kg Erotigotine 3 mg/kg metamizol, 2 mg/kg Fig. 4 US 2008/0008748 A1 Jan. 10, 2008 METHOD FOR TREATING PAIN USINGA normal-appearing tissues) in particular areas of the body and SUBSTITUTED 2-AMINOTETRALIN COMPOUND is frequently associated with a poor sleep pattern and/or stressful environment. Diagnosis offibromyalgia is typically 0001) This application claims the benefit under 35 U.S.C. based on a history of widespread pain (e.g., bilateral, upper S119 of European Patent Application No. EP 06 012 815.4, and lower body, and/or spinal pain), and presence of exces filed Jun. 22, 2006, the full disclosure of which is incorpo sive tenderness on applying pressure to a number of (some rated herein by reference. times more precisely defined as at least 11 out of 18) specific muscle-tender sites. FMS is typically a chronic syndrome FIELD OF THE INVENTION that causes pain and stiffness throughout the tissues that 0002 The present invention relates to methods for treat Support and move the bones and joints. ment (including prevention and/or alleviation) of various 0009 Treatment of fibromyalgia is conventionally based types of pain in a Subject. on pain relievers, non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, tranquilizers and antidepres BACKGROUND OF THE INVENTION sants, none of which are universally effective. 0003 Pain is a complex physiological process that 0010 Fibromyalgia patients often sleep poorly and may involves a number of sensory and neural mechanisms. Acute experience some relief by taking an antidepressant such as pain is typically a physiological signal indicating a potential amitriptyline at bedtime. See Goldenberg et al., J. Am. Med. or actual injury. Chronic pain can be somatogenic (organic) Assoc. 292(19):2388-2395 (2004). or psychogenic. Chronic pain is frequently accompanied or 0011. A goal in treating fibromyalgia is to decrease pain followed by vegetative signs, such as, for example, lassitude and to increase function. Fibromyalgia has been reviewed, or sleep disturbance. for example by Nampiaparampil & Shmerling, Am. J. 0004 Somatogenic pain may be of nociceptive, inflam Manag. Care 10(11 Pt 1):794-800 (2004). matory or neuropathic origin. Nociceptive pain is related to 0012 Myofascial pain syndrome (MPS) is a chronic activation of Somatic or visceral pain-sensitive nerve fibers, non-degenerative, non-inflammatory musculoskeletal con typically by physical or chemical injury to tissues. Inflam dition often associated with spasm or pain in the masticatory matory pain results from inflammation, for example an muscles. Distinct areas within muscles or their delicate inflammatory response of living tissues to any stimulus connective tissue coverings (fascia) become abnormally including injury, infection or irritation. Neuropathic pain thickened or tight. When the myofascial tissues tighten and results from dysfunction in the nervous system. Neuropathic lose their elasticity, the ability of neurotransmitters to send pain is believed to be Sustained by aberrant Somatosensory and receive messages between the brain and body is dis mechanisms in the peripheral nervous system, the central rupted. Specific discrete areas of muscle may be tender when nervous system (CNS), or both. firm fingertip pressure is applied; these areas are called 0005 Non-inflammatory musculoskeletal pain is a par tender or trigger points. (Both areas are tender, but trigger ticular form of chronic pain that is generally not traced to a points additionally radiate the pain to a distant site.) Symp specific structural or inflammatory cause and that generally toms of MPS include muscle stiffness and aching and sharp does not appear to be induced by tissue damage and mac shooting pains or tingling and numbness in areas distant rophage infiltration (resulting in edema) as occurs in a from a trigger point. The discomfort may cause sleep classical immune system response. disturbance, fatigue and depression. Most commonly trigger points are in the jaw (temporomandibular) region, neck, 0006 Although non-inflammatory musculoskeletal pain back or buttocks. is believed to result from peripheral and/or central sensiti Zation, the cause is not presently fully understood. It is often 0013) Myofascial pain differs from fibromyalgia: MPS associated with physical or mental stress, lack of adequate or and FMS are two separate entities, each having its own restful sleep, or exposure to cold or damp. Non-inflamma pathology, but sharing the muscle as a common pathway of tory musculoskeletal pain is also believed to be associated pain. Myofascial pain is typically a more localized or with or precipitated by systemic disorders such as viral or regional (along the muscle and Surrounding fascia tissues) other infections. Examples of non-inflammatory musculosk pain process that is often associated with trigger point eletal pain include neck and shoulder pain and spasms, low tenderness. Myofascial pain can be treated by a variety of back pain, and achy chest or thigh muscles. Non-inflamma methods (sometimes in combination) including stretching, tory musculoskeletal pain may be generalized or localized. ultrasound, ice sprays with stretching, exercises, and injec Understanding of the basic causes and mechanisms, animal tions of anesthetic. and other models for studying non-inflammatory muscu 0014) A further non-inflammatory musculoskeletal pain loskeletal pain, and treatment regimens are all areas where condition is back pain, notably low back pain. Back pain is a need for improvement exists. a common musculoskeletal symptom that may be either 0007 Fibromyalgia syndrome (FMS) and myofascial acute or chronic. It may be caused by a variety of diseases pain syndrome (MPS) are medical conditions characterized and disorders that affect the lumbar spine. Low back pain is by fibromyalgia and myofascial pain respectively, which are often accompanied by Sciatica, which is pain that involves two types of non-inflammatory musculoskeletal pain. the sciatic nerve and is felt in the lower back, the buttocks, 0008 FMS is a complex syndrome associated with sig and the backs of the thighs. nificant impairment of quality of life and can result in 0015 Non-inflammatory musculoskeletal pain such as Substantial financial costs. Fibromyalgia is a systemic pro fibromyalgia, myofascial pain and back pain involves cess that typically causes tender points (local tender areas in increased muscle sensitivity as an important manifestation. US 2008/0008748 A1 Jan. 10, 2008 Increased muscle sensitivity is characterized by pain evoked 0027 Holman, Arthritis & Rheumatism 50(Suppl. by a normally non-nociceptive stimulus (allodynia) or 9):S698 (2004). increased pain intensity evoked by nociceptive stimuli (hyperalgesia). The term “allodynia' refers to a normally 0028. Holman et al., Arthritis & Rheumatism 52(8):2495 innocuous somatosensory stimulation that evokes abnormal 2505 (2005). intense pain sensation with an explosive, radiating character often outlasting stimulus or trigger duration (i.e., pain due to 0029. These dopamine agonists are known to commonly a stimulus that does not normally provoke pain). The term lead, usually in the beginning of therapy and as a function "hyperalgesia' refers to a noxious stimulation that evokes of the dosage administered, to various side effects including, more intense and prolonged pain sensations (i.e., an for example, psychiatric, neurological, vascular and gas increased response to a stimulus that is normally painful). trointestinal effects. Psychiatric effects reported for prami 0016 Two classes of drugs are generally employed for pexole or ropinirole have included insomnia, hallucinations treatment of various types of pain: non-opioid analgesics, and confusion. Neurological effects have included syncope including acetaminophen
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