US2011218186A1PendingUtilityA1

Spirocyclic heterocyclic derivatives and methods of their use

Assignee: ADOLOR CORPPriority: Mar 31, 2005Filed: Apr 29, 2011Published: Sep 8, 2011
Est. expiryMar 31, 2025(expired)· nominal 20-yr term from priority
A61P 43/00A61P 9/00A61P 31/00A61P 31/10A61P 25/04A61P 25/08A61P 25/00A61P 25/24A61P 31/12A61P 25/16A61P 29/00C07D 491/10C07D 493/10C07D 223/14C07D 495/10C07D 311/96A61P 13/02C07D 221/20A61P 23/00A61P 15/10A61K 31/438C07D 491/107
51
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Claims

Abstract

Spirocyclic heterocyclic derivatives, pharmaceutical compositions containing these compounds, and methods for their pharmaceutical use are disclosed. In certain embodiments, the spirocyclic heterocyclic derivatives are ligands of the δ opioid receptor and may be useful, inter alia, for treating and/or preventing pain, anxiety, gastrointestinal disorders, and other δ opioid receptor-mediated conditions.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition, comprising:
 a pharmaceutically acceptable carrier; and a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein:
 D is: 
 
       
       
         
           
           
               
               
           
         
         
           K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
           R 23 , R 24 , and R 26  are each independently H or alkyl; 
           p is 1; 
           A 2  and B 2  are each H, or together form a double bond; and 
           X 2  is —CH 2 — or —O—; 
         
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         2 . A pharmaceutical composition according to  claim 1 , wherein the compound of formula XXVIII has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         3 . A pharmaceutical composition according to  claim 1 , further comprising an opioid, an agent for the treatment of neuralgia/neuropathic pain, an agent for the treatment of depression, an agent for the treatment of incontinence, or an anti-Parkinson's agent. 
     
     
         4 . A pharmaceutical composition according to  claim 3 , wherein said opioid is alfentanil, allylprodine, alphaprodine, anileridine, benzyl-morphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, cyclazocine, desomorphine, dextromoramide, dezocine, diampromide, diamorphone, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioaphetylbutyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, heroin, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levallorphan, levorphanol, levophenacylmorphan, lofentanil, loperamide, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, normorphine, norpinanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenomorphan, phanazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propiram, propoxyphene, sulfentanil, tilidine, tramadol, a diastereoisomer thereof, a pharmaceutically acceptable salt thereof, a complex thereof, or a mixture thereof. 
     
     
         5 . A pharmaceutical composition according to  claim 3 , wherein said agent for the treatment of neuralgia/neuropathic pain is a mild OTC analgesic, a narcotic analgesic, an anti-seizure medication or an anti-depressant. 
     
     
         6 . A pharmaceutical composition according to  claim 3 , wherein said agent for the treatment of depression is a selective serotonin re-uptake inhibitor, a tricyclic compound, a monoamine oxidase inhibitor, or an antidepressant compound belonging to the heterocyclic class. 
     
     
         7 . A pharmaceutical composition according to  claim 3 , wherein said agent for the treatment of urge incontinence is an anticholinergic agent, an antispasmodic medication, a tricyclic antidepressant, a calcium channel blocker or a beta agonist. 
     
     
         8 . A pharmaceutical composition according to  claim 3 , further comprising:
 an antibiotic, antiviral, antifungal, anti-inflammatory, anesthetic, or mixture thereof.   
     
     
         9 . A method of binding opioid receptors in a patient in need thereof, comprising the step of:
 administering to said patient an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein:
 D is: 
 
       
       
         
           
           
               
               
           
         
         
           K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
           R 23 , R 24 , and R 26  are each independently H or alkyl; 
           p is 1; 
           A 2  and B 2  are each H, or together form a double bond; and 
           X 2  is —CH 2 — or —O—; 
         
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         10 . A method according to  claim 9 , wherein said compound binds δ opioid receptors. 
     
     
         11 . A method according to  claim 10 , wherein said δ opioid receptors are located in the central nervous system. 
     
     
         12 . A method according to  claim 10 , wherein said δ opioid receptors are located peripherally to the central nervous system. 
     
     
         13 . A method according to  claim 9 , wherein said binding modulates the activity of said opioid receptors. 
     
     
         14 . A method according to  claim 13 , wherein said binding agonizes the activity of said opioid receptors. 
     
     
         15 . A method according to  claim 12 , wherein said compound does not substantially cross the blood-brain bather. 
     
     
         16 . A method of preventing, inhibiting or treating a condition, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof; 
         said condition selected from any one of the group consisting of: pain, gastrointestinal dysfunction, a urogenital disorder, an immunomodulatory disorder, an inflammatory disorder, a mood disorder, anxiety, a respiratory function disorder, a stress-related disorder, attention deficit hyperactivity disorder, a sympathetic nervous system disorder, tussis, a motor disorder, stroke, cardiac arrhythmia, glaucoma, sexual dysfunction, and substance addiction. 
       
     
     
         17 . A method of preventing, inhibiting or treating a condition, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof; 
         said condition selected from any one of the group consisting of: shock, brain edema, cerebral ischemia, cerebral deficits subsequent to cardiac bypass surgery and grafting, systemic lupus erythematosus, Hodgkin's disease, Sjogren's disease, epilepsy, and rejection in organ transplants and skin grafts. 
       
     
     
         18 . A method of improving organ and cell survival, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
       
       or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
     
     
         19 . A method of preventing, inhibiting or treating pain, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         20 . A method of preventing, inhibiting or treating a urogenital disorder, comprising the step of:
 administering to a patient in need thereof an effective amount a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         21 . A method of preventing, inhibiting or treating an inflammatory disorder, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         22 . A method of preventing, inhibiting or treating a mood disorder, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         23 . A method of preventing, inhibiting or treating anxiety, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         24 . A method of preventing, inhibiting or treating a motor dysfunction, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         25 . A method according to  claim 24 , wherein the motor dysfunction is Parkinson's disease. 
     
     
         26 . A method according to  claim 24 , wherein the motor dysfunction is tremors, Tourette's syndrome, or dyskinesia. 
     
     
         27 . A method of preventing, inhibiting or treating cardiac arrhythmia, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         28 . A method of preventing, inhibiting or treating sexual dysfunction, comprising the step of:
 administering to a patient in need thereof an effective amount of a compound according to formula XXVIII:   
       
         
           
           
               
               
           
         
         wherein: 
         D is: 
       
       
         
           
           
               
               
           
         
         K is carboxy (—COOH), —C(═O)—O-alkyl, —S(═O) 2 —N(alkyl)(alkyl), heteroaryl, alkylheteroaryl, aminocarbonyl (—C(═O)—NH 2 ), or N-alkylaminocarbonyl (—C(═O)—NH(alkyl)); 
         R 23 , R 24 , and R 26  are each independently H or alkyl; 
         p is 1; 
         A 2  and B 2  are each H, or together form a double bond; and 
         X 2  is —CH 2 — or —O—; 
         or a stereoisomer, prodrug, pharmaceutically acceptable salt, hydrate, solvate, acid salt hydrate, or N-oxide thereof. 
       
     
     
         29 . A method according to  claim 19  wherein the pain is selected from the group consisting of acute pain and chronic pain. 
     
     
         30 . A method according to  claim 29  wherein the pain is acute pain. 
     
     
         31 . A method according to  claim 29  wherein the pain is chronic pain. 
     
     
         32 . A method according to  claim 19  wherein the pain is selected from the group consisting of nociceptive pain, inflammatory pain, visceral pain, somatic pain, neuralgia, neuropathic pain, AIDS pain, cancer pain, phantom pain, psychogenic pain, pain resulting from hyperalgesia, pain caused by rheumatoid arthritis, migraine and allodynia. 
     
     
         33 . A method according to  claim 32  wherein the pain is neuropathic pain. 
     
     
         34 . A method according to  claim 32  wherein the pain is migraine. 
     
     
         35 . A method according to  claim 9 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         36 . A method according to  claim 16 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         37 . A method according to  claim 17 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         38 . A method according to  claim 18 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         39 . A method according to  claim 19 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         40 . A method according to  claim 20 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         41 . A method according to  claim 21 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         42 . A method according to  claim 22 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         43 . A method according to  claim 23 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         44 . A method according to  claim 24 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         45 . A method according to  claim 25 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         46 . A method according to  claim 28 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         47 . A method according to  claim 29 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         48 . A method according to  claim 30 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         49 . A method according to  claim 31 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         50 . A method according to  claim 32 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         51 . A method according to  claim 33 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         52 . A method according to  claim 34 , wherein said compound has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         53 . A pharmaceutical composition according to  claim 1 , wherein the compound of formula XXVIII is selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         54 . A pharmaceutical composition according to  claim 53 , wherein the compound of formula XXVIII is selected from the group consisting of: 
       
         
           
           
               
               
           
         
       
     
     
         55 . A method according to  claim 9 , wherein the compound of formula XXVIII is selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         56 . A method according to  claim 55 , wherein the compound of formula XXVIII is selected from the group consisting of:

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