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CA-3024286-C - USE OF CARBAMATE COMPOUND FOR PREVENTING OR TREATING FIBROMYALGIA OR FUNCTIONAL SYNDROME ASSOCIATED WITH FIBROMYALGIA

CA3024286CCA 3024286 CCA3024286 CCA 3024286CCA-3024286-C

Abstract

The present invention relates to a use of a carbamate compound of chemical formula 1 (see formula 1) or a pharmaceutically acceptable salt thereof, a solvate or a hydrate; for preventing or treating fibromyalgia or a functional syndrome associated with fibromyalgia.

Inventors

  • Min Jae JO
  • Han Ju Yi
  • Sun Gwan Hwang

Assignees

  • SK BIOPHARMACEUTICALS CO., LTD.

Dates

Publication Date
20260505
Application Date
20170518
Priority Date
20160519

Claims (9)

  1. CLAIMS 1. Use of a carbamate compound of the following Formula 1, or a pharmaceutically acceptable salt, solvate or hydrate thereof, for the prevention or treatment of fibromyalgia or associated functional symptoms of fibromyalgia in a subject: [Formula 1] wherein, R1 and R2 are each independently selected from hydrogen, halogen, C1-Ca alkyl, halo-C1-Ca alkyl, C1-Ca thioalkoxy and C1-Ca alkoxy; and one of A1 and A2 is CH, and the other is N, and wherein the associated functional symptoms of fibromyalgia are insomnia, cognitive disorders, body temperature abnormalities, irritable bowel syndrome, Sicca symptoms, hyperhidrosis (increased sweating), dizziness, tremor, dyspnoea, arrhythmias, paraesthesias chronic or fatigue.
  2. 2. Use of a carbamate compound of the following Formula 1, or a pharmaceutically acceptable salt, solvate or hydrate thereof, in the manufacture of a medicament for the prevention or treatment of fibromyalgia or associated functional symptoms of fibromyalgia in a subject: [Formula 1] wherein, 21 Date Re9ue/Date Received 2024-03-25 R1 and R2 are each independently selected from hydrogen, halogen, C1-Cs alkyl, halo-C1-Cs alkyl, C1-Cs thioalkoxy and C1-Cs alkoxy; and one of A1 and A2 is CH, and the other is N, and wherein the associated functional symptoms of fibromyalgia are insomnia, cognitive disorders, body temperature abnormalities, irritable bowel syndrome, Sicca symptoms, hyperhidrosis (increased sweating), dizziness, tremor, dyspnoea, arrhythmias, paraesthesias or chronic fatigue.
  3. 3. The use according to Claim 1 or 2, wherein R1 and R2 are each independently selected from hydrogen, halogen and C1-Cs alkyl.
  4. 4. The use according to Claim 1 or 2, wherein the carbamate compound of Formula 1 is carbamic acid (R)-1-(2-chlorophenyl)-2-tetrazol-2-yl-ethyl ester of the following Formula 2: [Formula 2]
  5. 5. The use according to any one of Claims 1 to 4, wherein the fibromyalgia is fibromyositis, fibrositis, muscular rheumatism, musculoskeletal pain syndrome, non-articular rheumatism, pain due to rheumatoid muscularitis, tension myalgia, hyperalgesia, persistent pain, stiffness or tenderness.
  6. 6. The use according to any one of Claims 1 to 5, wherein the carbamate compound of Formula 1 is to be used in an amount of 50 to 500 mg based on once-daily administration.
  7. 7. The use according to any one of Claims 1 to 6, wherein the subject is a mammal.
  8. 8. The use according to Claim 7, wherein the mammal is a human. 22 Date Re9ue/Date Received 2024-03-25
  9. 9. The use according to any one of Claims 1 to 8, wherein the carbamate compound is for oral, parenteral, intravenous, intramuscular, subcutaneous or rectal administration. 23 Date Re9ue/Date Received 2024-03-25

Description

USE OF CARBAMATE COMPOUND FOR PREVENTING OR TREATING FIBROMYALGIA OR FUNCTIONAL SYNDROME ASSOCIATED WITH FIB ROMY ALOIA [Technical field] The present invention relates to use of a carbamate compound of the following Formula l for the purpose of preventing or treating fibromyalgia or associated functional symptoms of fibromyalgia, by administering a pharmaceutical composition comprising said carbamate compound: [Formula 1] wherein, Rt, R2, A1 and A2 are as defined herein. [Background art] Fibromyalgia, also known as fibromyalgia syndrome, is a complex syndrome consisting of pain, such as central sensitization, hyperalgesia and spontaneous pain. Fibromyalgia is a chronic systemic pain disorder that is accompanied by various symptoms such as chronic fatigue, sleep disorder, cognitive disorder and depression. In particular, it often involves extensive pain, stiffness and tenderness in the musculoskeletal-related tissues, including muscles, tendons and ligaments (Bennett RM, Clinical manifestations and diagnosis of fibromyalgia, Rheum Dis Clin North Am., 2009; Clauw DJ, Fibromyalgia and related conditions, Mayo Clin Proc., 2015). Fibromyalgia has a prevalence rate of 2 to 8% according to diagnostic criteria. According to the diagnostic criteria published in 1990, fibromyalgia was diagnosed by the presence or absence of chronic systemic pain and a certain number of tender points (pain spots), and under these criteria fibromyalgia was much more prevalent in women than in men. According to the newly proposed standards in 2010 and 2011, the number of tender points (pain spots) is no longer included in the criteria for the diagnosis of fibromyalgia, and instead, various symptoms associated with chronic pain such as fatigue, sleeping disorder, cognitive disorder and depression are included in the criteria for the diagnosis. As a result, the number of male patients diagnosed with fibromyalgia increased, and the ratio of female to male patients changed from 9 : 1 in 1990 to 2 : 1 in the new standard. Almost all of patients diagnosed with fibromyalgia experience chronic pain many times in different parts of the body for a lifetime, and pain experience at different parts of the body eventually leads to chronic systemic pain. Fibromyalgia often begins in childhood or adolescence, and patients diagnosed with fibromyalgia are likely to experience headache, menstrual irregularities, temporomandibular joint disorder, chronic fatigue, inflammatory bowel disease and other types of partial pain. In these patients, surgical treatment to remove 2 partial pain does not result in successful pain relief. Fibromyalgia is a typical centralized pain, a pain situation that is distinctly different from nociceptive pain and neuropathic pain, which clinicians can rather easily distinguish. The pathological mechanism of fibromyalgia is not fully understood until now, but it is believed that various environmental factors as well as genetic factors are involved. The probability of suffering from the same disease in families of patients diagnosed with fibromyalgia is 8.5 times higher than that of the general population. It was reported in certain studies of twins that about 50% of fibromyalgia is caused by genetic factors and about 50% by environmental factors. The main environmental factor that triggers the induction of fibromyalgia is a stress of various causes such as those that induce acute pain for several weeks. The onset of fibromyalgia is influenced by a variety of psychological, behavioral and social factors, and these various etiologic factors make treatment of the disease complicated. A variety of pharmacological and non-pharmacological treatments have been used to treat fibromyalgia. Drugs such as tricyclic compounds, gabapentinoids and serotoninnorepinephrine reuptake inhibitors have been used for pharmacological treatment, and numerous drugs have been used in combination due to the complicated and various factorsinvolving pathogenesis offibromyalgia. Although various medicines have been adopted for the treatment of fibromyalgia, there is still a limitation on their use due to an unsatisfactory level of therapeutic effect or adverse effects because of complex pathologies accompanied by symptoms such as chronic fatigue and depression, as well as systemic musculoskeletal pain. Hence, there is still a need for new drugs with improved efficacy and fewer side effects. 3 [Disclosure of the Invention] [Problem to be solved] The present invention is intended to provide a method for the prevention or treatment of fibromyalgia or associated functional symptoms of fibromyalgia. The present invention is also intended to provide the use of a carbamate compound of the following Formula 1, or a pharmaceutically acceptable salt, solvate or hydrate thereof, for the prevention or treatment of fibromyalgia or associated functional symptoms of fibromyalgia: [Formula 1] wherein, R1, R2, A1 and A2 are as defined herein. [Technical Solution to the Problem