Methods for concomitant administration of colchicine and a...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C514S629000

Reexamination Certificate

active

07915269

ABSTRACT:
Methods for concomitant administration of colchicine together with one or more second active agents, e.g., ketoconazole and ritonavir, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for concomitant administration of colchicine together with second active agents are also provided.

REFERENCES:
patent: 5426224 (1995-06-01), Lee et al.
patent: 5914332 (1999-06-01), Sham et al.
patent: 5968972 (1999-10-01), Broder et al.
patent: 6037157 (2000-03-01), Norbeck et al.
patent: 6245805 (2001-06-01), Broder et al.
patent: 6896900 (2005-05-01), Gosselin et al.
patent: 7601758 (2009-10-01), Davis
patent: 7619004 (2009-11-01), Davis
Creighton et al (Int J STD AIDS 16:362-364, 2005).
Ogbru and Marks (www.medicinenet.com/colchicine, available online as of Sep. 8, 2008 and based on FDA Prescribing Information).
Rangno (Management of Gout with Colchicine, available online as of Jul. 5, 2003).
Horn et al (Pharmacy Times, May 2006, p. 111).
Heeswijk et al (AIDS 14:F103-F110, 2000).
DRUGS.COM; “colchicine and ritonavir interactions”, printed Jan. 5, 2009; “colchicine”, printed Jan. 9, 2009; and “ritonavir”, printed Jan. 9, 2009.
Horn, et al.; “Life-Threatening Colchicine Drug Interactions”; Pharmacy Times; pp. 111; (May 2006).
Hsu, et al; “Ritonavir; Clinical Pharmacokinetics and Interactions with Other Anti-HIV Agents”; Clinical Pharmacokinet; 35; pp. 275-291; (1998).
Niel, et al.; “Colchicine Today”; Joint Bone Spine; 73; pp. 672-678; (2006).
Perez-Ruiz, et al.; “Optimisation of the Treatment of Acute Gout”; BioDrugs; 13; pp. 415-423; (2000).
Terkeltaub, Robert A.; “Gout”; The New England Journal of Medicine; 349; pp. 1647-1655; (2003).
Van Der Velden, et al; “Colchicine-Induced Neuromyopathy in a Patient With Chronic Renal Failure: The Role of Clarithromycin”; Netherlands, The Journal of Medicine; 66; pp. 204-206; (2008).
Zhou, et. al; “Clinical Outcomes and Management of Mechanism-Based Inhibition of Cytochrome P450 3A4”; Therapeutics and Clinical Risk Management; 1; pp. 3-13; (2005).
Drugs.com;“Colchicine Dosage” (available online http://www.drugs.com/dosage/colchicine.html); 6 pages; accessed Sep. 20, 2010.
Rx-s.net/weblog/more/colchicine-indications-and-dosage/; “Colchicine Indications and Dosage”; 5 pages; last revised Aug. 2, 2005.
U.S. Appl. No. 12/858,754, filed Aug. 18, 2010; Non-Final Office Action dated Oct. 5, 2010; 38 pages.
Achtert et al. “Pharmacokinetics/bioavailability of colchicine in healthy male volunteers” Eur. J. Drug Metab. Pharmacokinet. 1989, 14(4): 317-322.
FDA; “Drugs”; Questions and Answers About FDA's Enforcement Action Against Unapproved Injectable Colchicine Products“; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Enforcement Action”; printed Dec. 6, 2010.
FDA; “In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling”; Nov. 1999 (:FDA Guidance) 19 pages.
Sabourand, et al.; “Pharmacokinetics of Colchicine. A review of Experimental and Clinical Data”; 2 Gastroenterol (Suppl. 1)30: pp. 35-39; (1992).
U.S. Appl. No. 12/372,046, filed Feb. 17, 2009; Non-Final Office Action dated Jan. 26, 2010, 30 pages.
U.S. Appl. No. 12/372,046, filed Feb. 17, 2009; Non-Final Office Action dated May 18, 2009; 9 pages.
U.S. Appl. No. 12/372,046, filed Feb. 17, 2009; Final-Office Action dated Sep. 11, 2009; 10 pages.
U.S. Appl. No. 12/372,046, filed Feb. 17, 2009; Non-Final Office Action dated Jul. 14, 2009; 10 pages.
U.S. Appl. No. 12/688,038, filed Jan. 15, 2010; Final Office Action dated Jun. 28, 2010; 33 pages.
U.S. Appl. No. 12/688,038, filed Jan. 15, 2010; Non-Final Office Action dated Apr. 2, 2010; 36 pages.
Colchicine-Probenecid, Colchicine-Probenecid—Side effect guide, warning symptoms; http://www.healthgrades.com/drug-ratings/drug/sideeffects/2207/Colchicine-Probenecid; printed Dec. 2, 2009; 2 pages.
COLCYRS, Prescribing Information, www.colcrys.com/assets/pdf/COLCRYS-Full-Prescribing—Information.pdf; pp. 1-5 ; revised Sep. 2009; printed Oct. 19, 2009.
Herrewege, et al; A Dual Chamber Model of Female Cervical Mucosa for the Study of HIV Transmission and for the Evaluation of Candidate HIV Microbicides; Antiviral Research; 74; pp. 111-124; (2007).
Lacy et al; “Lexi-Comp's Clinical Reference Library”, Drug Information Handbook, 7th Ed., pp. 108-109 and 292-293; 1999-2000.
Leiken et al; “Colchicine”; Poisoning and Toxicology Handbook; 4th Ed., p. 216; (2007).
Terkeltaub, Robert A.; “Colchicine Update: 2008”; Seminars in Arthritis and Rheumatism; VA Medical Center, University of California, San Diego; 38(6); pp. 411-419; (2009).
Terkeltaub et al.; “Comparison of Low-Dose vs High-Dose Oral Colchicine Regimens in Patients with Gout Flares-Presentation”; Presentation at the American College of Rheumatology Scientific Meeting; San Francisco, CA; 23 pages; Oct. 24-29; 2008.
Terkeltaub et al; “Clinical Relevance of P-gp and CYP3A4 on Colchicine Metabolism and Elimination”; Presentation at the American College of Rheumatology Scientific Meeting; San Francisco, CA; 19 pages; Oct. 24-29, 2008.
Wang et al; “HMG-CoA Reductase Inhibitors (Statins) Characterized as Direct Inhibitors of P-Glycoprotein”; Pharmaceutical Research; vol. 18(6); pp. 800-806; (2001).
Keven, et al.: “Long-Term Outcome of Renal Transplantation in Patients with Familial Mediterranean Fever Amyloidosis: A Single-Center Experience”; Transplantation Proceedings; 3; pp. 2632-2634; (2004).
Ben-Chetrit; Colchicine: 1998 Update; Seminars in Arthritis and Rheumatism; 28; pp. 48-59; (1998).

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