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(12) United States Patent (10) Patent No.: US 7,884,090 B2 Bonner, Jr

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(12) United States Patent (10) Patent No.: US 7,884,090 B2 Bonner, Jr US007884.090B2 (12) United States Patent (10) Patent No.: US 7,884,090 B2 Bonner, Jr. et al. (45) Date of Patent: Feb. 8, 2011 (54) COMPOSITIONS AND METHODS FOR THE 6,326,364 B1 12/2001 Lin et al. TREATMENT OF ARTHRTIS 6,416,779 B1 7/2002 DAugustine et al. 6,465,473 B1 10/2002 Bonner, Jr. et al. (75) Inventors: Ernest L. Bonner, Jr., 1406 Park St., 6,765,000 B2 7/2004 Bonner, Jr. et al. Suite 400, Alameda, CA (US) 94501; 7,053,073 B2 5/2006 Bonner, Jr. et al. Robert Hines, Fayetteville, NC (US) 2002fOO31558 A1 3, 2002 Yoo 2002fO151519 A1 10/2002 Shepard (73) Assignee: Ernest L. Bonner, Jr., Hillsborough, CA 2003/0055022 A1 3/2003 Bonner, Jr. et al. (US) 2005/005964.0 A1 3/2005 Bonner, Jr. et al. 2005/O137181 A1 6/2005 Bonner, Jr. et al. *) Notice: Subject to anyy disclaimer, the term of this 2005/0176690 A1 8/2005 Bonner, Jr. et al. patent is extended or adjusted under 35 2006/0172956 A1 8, 2006 Bonner et al. U.S.C. 154(b) by 1370 days. (21) Appl. No.: 11/296,575 OTHER PUBLICATIONS Lichtman et al., “Reactivation of Arthritis Induced by Small Bowel (22) Filed: Dec. 7, 2005 Bacterial Overgrowth in Rats: Role of Cytokines, Bacteria, and Bac terial Polymers”, Infection and Immunity, 63(6):2295-2301 (1995). (65) Prior Publication Data Schirmer et al., “Acyclovir in Acute Oligoarticular Herpetic Arthri tis”, Lancet, 346(8976): 712-713 (1995). US 2006/O172956A1 Aug. 3, 2006 Stebbings et al., “Chickenpox Monoarthritis: Demonstration of Varicella-Zoster Virus in Joint Fluid by Polymerase Chain Reaction'. Related U.S. Application Data British Journal of Rheumatology, 37:311-313 (1998). (63) Continuation-in-part of application No. 1 1/096,260. Toussirot et al., “Do Minocycline and Other Tetracyclines Have a filed on Mar. 29, 2005, which is a continuation-in-part Place in Rheumatology”. Rev. Rheum Engl. Ed., 64(7-9):474-480 of application No. 11/054,921, filed on Feb. 9, 2005, (1997). Acyclovir package Insert from South African Electronic Package which is a continuation-in-part of application No. Inserts, 3 pages; published Oct. 1, 1997. 10/896,612, filed on Jul. 20, 2004, now Pat. No. 7,053, Arnold et al., “Poststreptococcal reactive arthritis'. Annals of the 073, which is a continuation-in-part of application No. Rheumatic Diseases, 48(8):686-688 (1989). 10/271,117, filed on Oct. 15, 2002, now Pat. No. 6,765, NDA 05-733 for Zithromax Injection, 218 pages (Azithromycin) 000, which is a continuation-in-part of application No. dated Jan. 30, 1997. 09/510,704, filed on Feb. 22, 2000, now Pat. No. 6,465, Swanson, J.M. and Chenitz, W.C., “The prevention and management 473, which is a continuation-in-part of application No. of genital herpes: a community health approach'. Journal of Com 09/270,962, filed on Mar. 17, 1999, now Pat. No. munity Health Nursing, 6(4):209-221 (1989). 6,087,382. Tuffrey et al., “The effect of a single oral dose of azithromycin on chlamydial infertility and oviduct ultrastructure in mice'. Journal of (51) Int. Cl. Antimicrobial Chemotherapy, 34:989-999 (abstract only) (1994). A6 IK3I/65 (2006.01) Astrauskiene, D., “Efficacy of empirically prescribed amoxicillin A 6LX3/59 (2006.01) and amoxicillin+ clavulanic acid in children's reactive arthritis: a A6 IK3I/44 (2006.01) randomized trial.” Clin Exp Rheumatol. Jul.-Aug. 2003:21(4):515 A6 IK3I/42 (2006.01) 21. A 6LX3L/95 (2006.01) Ayoub et al., “Poststreptococcal Reactive Arthritis.” Curr Opin Rheumatol. Jul. 2000; 12(4):306-10. (52) U.S. Cl. .................... 514/152; 514/262.1; 514/356; Bardin, T., "Antimicrobial Therapy in Inflammatory Joint Disease.” 514/398: 514/561 Rev. Rhum Engl Ed. Nov. 1998:65(11):625-9. (58) Field of Classification Search ................. 514/152, Bardinet al., “Antibiotic Trials in Reactive Arthritis.” Rev. Rhum Engl 514/154, 262.1, 356, 398,561 Ed. Jan. 30, 1999;66(1 Suppl):63S-66S. See application file for complete search history. Bell et al., “Management of sexually acquired reactive arthritis in 19 North Thames GUM clinics.” IntJSTD AIDS, Mar. 2004:15(3):195 (56) References Cited 8. U.S. PATENT DOCUMENTS (Continued) 2.946,801 A 7, 1960 Fields 3,148.212 A 9, 1964 Boothe et al. Primary Examiner Raymond J Henley, III 3,226,436 A 12/1965 Petisi et al. (74) Attorney, Agent, or Firm—Brian Beverly; Beeson 4,177,796 A 12/1979 Franco-Vila Skinner Beverly, LLP 4,521,411 A 6, 1985 Koloff 5,262,173 A 11/1993 Sheth et al. (57) ABSTRACT 5,523,297 A 6, 1996 Pruzanski et al. 5,728,680 A 3, 1998 Morozov et al. 5,952,367 A 9, 1999 Pak The present invention provides compositions, combination of 5,972,389 A 10, 1999 Shell et al. medicaments, and methods for the treatment of certain con 6,034,122 A 3/2000 Chayen ditions such as arthritis, and in particular, reactive arthritis, 6,087,382 A 7/2000 Bonner, Jr. et al. osteoarthritis, and bursitis, among others. 6,093.414 A 7/2000 Capelli 6, 197,776 B1 3/2001 Bonner, Jr. et al. 42 Claims, No Drawings US 7,884,090 B2 Page 2 OTHER PUBLICATIONS Neumayr et al., “Chronic reactive arthritis associated with Calmette Guerin bacillus.” Dtsch Med Wochenschr. Sep. 13, Birdi et al., "Acute rheumatic feaver and poststreptococcal reactive 2002; 127(37): 1886-8. Article in German; abstract only is provided in arthritis: diagnostic and treatment practices of pediatric Subspecial English. ists in Canada.”: J Rheumatol. Jul. 2001:28(7): 1681-8. Palazzi et al., “Reactive arthritis: advances in diagnosis and treat Brandt et al., “Effects of doxycycline on progressionofosteoarthritis: ment.” Reumatismo. Apr.-Jun. 2002:54(2):105-12. Article in Italian; results of a randomized, placebo-controlled, double-blind trial.” abstract only is provided in English. Arthritis Rheum. Jul. 2005:52(7):2015-25. Palazzi et al., “Management of reactive arthritis.”Expert Opin Burnette et al., “Purification and Characterization of a Rat Liver Pharmacother. Jan. 2004:5(1):61-70. Enzyme that Hydrolyzes Valaciclovir, the z-Valyl Ester Prodrug of Pappas et al., “Unusual causes of reactive arthritis: Leptospira and Acyclovir.” Chem. Abs. AN#1995;673023, J. Biol. Chem., 270(26), Coxiella bumetii.” Clin Rheumatol. Oct. 2003:22(4-5):343-6. 15827-31 Pottet al. letter, “Long-termantibiotic treatment in reactive arthritis.” Ceroni et al., “Risks and complications of prolonged parenteral anti Lancet. Jan. 30, 1988;1(8579):24.5-6. biotic treatment in children with acute osteoarticular infections.” Shulman et al., “Poststreptococcal reactive arthritis.” Curr Opin Acta Orthop Belg. Oct. 2003:69(5):400-4. Rheumatol. Sep. 2002;14(5):562-5. Fryden et al., “Early antibiotic treatment of reactive arthritis associ Sieper et al., “Report on the Fourth International Workshop on Reac ated with enteric infections: clinical and serological study.” BMJ, tive Arthritis.” Apr. 2000: Arhritis Rheum. 2000, Apr:43(4):720-34. Dec. 8, 1990;301(6764): 1299-302. Sieper, J., “Reactive arthritis: practical procedure in diagnosis and Hopkinson, N., “Sexually-acquired reactive arthritis.” Hosp Med. problematic aspects of antibiotic therapy.” Z Rheumatol. Apr. Feb. 2001:62(2):83-5. Kamphuisen et al., “Two years of penicillin prophylaxis is sufficient 2003;62(2): 110-1. Article in German; abstract only is provided in to prevent clinically evident carditis in poststreptococcal reactive English. arthritis.” J Intern Med. Nov. 2001:250(5):449-52. Sieper et al., “No benefit of long-term ciprofloxacin treatment in Kloppenburg et al., “Antimicrobial therapy for rheumatoid arthritis.” patients with reactive arthritis and undifferentiated oligoarthritis: a Baillieres Clin Rheumatol. Nov. 1995:9(4):759-69. three-month, multicenter, double-blind, randomized, placebo-con Kocak et al., “Poststretptococcal Reactive Arthritis: Clinical Course trolled study.” Arthritis Rheum. Jul. 1999:42(7): 11386-96. and Outcome in 15 Patients.” Turk J Pediatri. Apr.-Jun. Sieper et al., “Expert Witness Reports in Rheumatology.” British 2000:42(2):10 1-4. Society for Rheumatology, 1998:37:715-20. Kvien et al., “Three month treatment of reactive arthritis with Smieja et al., “Randomised, blinded, placebo controlled trial of azithromycin: a EULAR double blind, placebo controlled study.” doxycycline for chronic Seronegative arthritis.” Ann Rheum Dis. Ann Rheum Dis. Sep. 2005:63(9): 1113-9. Dec. 2001: 60(12): 1088-94. Laasila et al., “Antibiotic treatment and long term prognosis of reac Svenungsson, B. “Reactive arthritis.” Int J STD AIDS. May-Jun. tive arthritis.” Ann Rheum Dis. Jul. 2003;62(7):655-8. 1995;6(3): 156-60. Lehman et al., "Clinical trials for post-streptococcal reactive arthri Toivanen et al., “Reactive Arthritis.” Curr Opin Rheumatol. Jul. tis.” Curr Rheumamtol Rep. Oct. 2001:3(5):363-4. 1997:9(4):321-7. Leirisalo-Repo, M. “Therapeutic aspects of Toivanen et al., “Effect of antimicrobial treatment on chronic reactive spondyhloarthropathies—a review.” Scand J Rheumatol. arthritis.” Clin Exp Rheumatol. May-Jun. 1993; 11(3):301-7. 1998:27(5):323-8. Toivanen et al., “Reactive arthritis.' Best Practice & Research Clini Loffler etal, “Clostridium difficile-associated reactive arthritis in two cal Rheumatology, Oct. 2004;18(5):689-703. children.” Joint Bone Spine. Jan. 2004:71(1):60-2. Toivanen, A., “Bacteria-Triggered reactive arthritis: implications for Morfin Maciel et al., “Reactive polyarthritis and painful antibacterial treatment.” Drugs. 2001:61(3):343-51. dermatographism caused by Helicobacter pylori,” Rev Alerg Mex. Zhang et al., “Experimental Yersinia-triggered reactive arthritis: May-Jun. 2002:49(3):99-102. Article in Spanish; abstract only is effect of a 3-week course of ciprofloxacin.” Br J Rheumatol.
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