(12) United States Patent (10) Patent No.: US 9,675,696 B2 Chamness (45) Date of Patent: *Jun

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(12) United States Patent (10) Patent No.: US 9,675,696 B2 Chamness (45) Date of Patent: *Jun USOO967.5696B2 (12) United States Patent (10) Patent No.: US 9,675,696 B2 Chamness (45) Date of Patent: *Jun. 13, 2017 (54) METHOD AND USE FOR INCREASING OTHER PUBLICATIONS EFFICACY OF ANT-ADHESIVE COMPOSITIONS IN CONTROLLING Borgens et al. “Immediate Recovery from spinal cord injury through NFLAMMATION AND PAN molecular repair of nerve membranes with polyethylene glycol FASEB J. 2000, 14, pp. 27-35.* (75) Inventor: Kathy L. Chamness, Memphis, TN Kaptanoglu et al., “Effects of magnesium Sulphate in experimental (US) spinal cord injury: evaluation with ultrastructural findings and early (73) Assignee: Warsaw Orthopedic, Inc., Warsaw, IN clinical results,” Journal of Clinical Neuroscience (2003); vol. 10, No. 3, pp. 329-334. (US) Borgens R B and Bohnert D., “Rapid recovery from spinal cord (*) Notice: Subject to any disclaimer, the term of this injury after Subcutaneously administered polyetheylene glycol.” patent is extended or adjusted under 35 Journal of Neuroscience Research (2001); vol. 66, pp. 1179-1186. Ditor D S et al., “Effects of polyethylene glycol and magnesium U.S.C. 154(b) by 1557 days. Sulfate administration on cinically relevant neurological outcomes after spinal cord injury in the rat.” Journal of Neuroscience This patent is Subject to a terminal dis Research (2007); vol. 85, pp. 1458-1467. claimer. The International Search Report and the Written Opinion of the International Searching Authority in PCT/US2007/067580. (21) Appl. No.: 11/598.397 Apan, A. et al., Postoperative magnesium Sulphate infusion reduces analgesic requirements in spinal anaesthesia, European Journal of Anaesthesiology, May 2004:21:766-769. (22) Filed: Nov. 14, 2006 Bhatia, A. et al., Effect of Intraoperative Magnesium Infusion on Perioperative Analgesia in Open Cholecystectomy, Journal of Clini (65) Prior Publication Data cal Anesthesia, Jun. 2004; 16(4):262-265. Bigal, ME et al., Intravenous magnesium Sulphate in the acute US 2008/O112921 A1 May 15, 2008 treatment of migraine without aura and migrain with aura, Cephalalgia, Jan. 2002:22(5):345-353. Bolcal, C. et al., Comparison of Magnesium Sulfate With Opioid (51) Int. Cl. and NSAIDs on Postoperative Pain Management After Coronary A6 IK 8/72 (2006.01) Artery Bypass Surgery, Journal of Cardiothoracic and Vascular A6 IK 45/06 (2006.01) Anesthesia, Dec. 2005; 19(6):714-718. A 6LX 3L/77 (2006.01) Brill, S. et al., Efficacy of intravenous magnesium in neuropathic pain, British Journal of Anaesthesia, May 2002;89(5):711-714. A6 IK33/06 (2006.01) Cete, Y. et al. A randomized prospective placebo-controlled study (52) U.S. Cl. of intravenous magnesium Sulphate vs. metoclopramide in the CPC .............. A61K 45/06 (2013.01); A61 K3I/77 management of acute migraine attacks in the Emergency Depart (2013.01); A61 K33/06 (2013.01) ment, Cephalalgia, May 2004:25(3): 199-204. Corbo, J. et al., Randomized Clinial Trial of Intravenous Magne (58) Field of Classification Search sium Sulfate as an Adjunctive Medication for Emergency Depart USPC ....................................................... 424/70.11 ment Treatment of Migraine Headache, Dec. 2001;38(6):621-627. See application file for complete search history. Crosby, V. et al., The Safety and Efficacy of a Single Dose (500 mg or 1g) of Intravenous Magnesium Sulfate in Neuropathic Pain (56) References Cited Poorly Responsive to Strong Opioid Analgesics in Patients with Cancer, Journal of Pain and Symptom Management, Jan. U.S. PATENT DOCUMENTS 2000; 19(1):35-39. Felsby, S. et al., NMDA receptor blockade in chronic neuropathic 3,026,248 A 3/1962 Noseworthy et al. pain: a comparison of ketamine and magnesium chloride, Pain, Feb. 4,020,162 A 4, 1977 Ghilardi et al. 1995:64(2):283-291. 4,451,447 A 5/1984 Kaplan et al. Hoane, M.R. et al., The behavioral effects of magnesium therapy on 5,605,687 A 2f1997 Lee et al. recovery of function following bilateral anterior medial cortex 5,686,488 A * 11/1997 Gamache et al. ............ 514,549 lesions in the rat, Brain Research Bulletin, Apr. 2003:60(1-2):105 6,037,331 A 3/2000 Shalaby et al. 114. 6,630,167 B2 10/2003 Zhang Izumi, Y. et al., Reduction of Infarct Volume By Magnesium. After 6,656,459 B2 12/2003 Kabanov et al. Middle Cerebral Artery Occlusion in Rats, Journal of Cerebral 6,869,938 B1 3/2005 Schwartz et al. Blood Flow and Metabolism, Nov. 1991; 11(6):1025-1030. 7,582,680 B1 9, 2009 Shi et al. McCartney, C.J. et al., A Qualitative Systematic Review of the Role 7,837.987 B2 11/2010 Shi et al. of N-Methyl-D-Aspartate Receptor Antagonists in Preventive Anal 8,153,112 B2 * 4/2012 Drapeau ................ A61K 31,74 gesia, Anesth Analg. May 2004:98(5): 1385-1400. 424/422 McIntosh, T.K. et al., Magnesium protects against neurological 2002/0136719 A1* 9/2002 Shenoy et al. ............. 424,130.1 deficit after brain injury, Brain Research, Mar. 1989:482(2):252 2003/0083231 A1* 5/2003 Ahlem ................... A61K 31.56 260. 514, 26 Moulin, D.E. et al., Systemic Drug Treatment for Chronic Muscu 2003/0118545 A1 6, 2003 Shi et al. loskeletal Pain, The Clinical Journal of Pain, Dec. 2001:17(4 2004/0037893 A1 2/2004 Hansen et al. ................ 424,682 Suppl):S86-S93. 2004/0214790 A1 10/2004 Borgens 2004/0258757 A1* 12/2004 Bosch et al. .................. 424/489 (Continued) 2005, OO69520 A1 3/2005 Shi et al. Primary Examiner — James Rogers 2005/OO74495 A1 4/2005 Schwartz et al. 2006/0067.976 A1 3f2006 Ferraro et al. ................ 424/426 (57) ABSTRACT 2007/0258938 A1 1 1/2007 Roy et al. A method and kits thereof for increasing the efficiency of anti-adhesive compositions by parenterally administering a FOREIGN PATENT DOCUMENTS composition comprising an effective amount of at least one pharmaceutically-acceptable anti-adhesive non-ionic poly GB 1250304 A 10, 1971 mer to a site of injury, controlling inflammation at the site of GB 1286.351 A 8, 1972 injury, and reducing pain. WO WOO1,285.44. A 4/2001 WO 02092107 11 2002 16 Claims, 5 Drawing Sheets US 9,675,696 B2 Page 2 (56) References Cited Bittner, G.D. et al., Reconnection of severed nerve axons with polyethylene glycol, Brain Research, 1986: 367(1-2):351-355. Shapiro, S. et al., Oscillating field stimulation for complete spinal OTHER PUBLICATIONS cord injury in humans: a Phase 1 trial, J Neurosurg Spine, Jan. 2005; Russell, I.J. et al., Treatment of Fibromyalgia Syndrome with Super 2(1):3-10. Resende, M.A. et al., Local transcutaneous electrical stimulation Malic R: A Randomized, Double Blind, Placebo Controlled, Cross (TENS) effects in experimental inflammatory edema and pain, over Pilot Study, Journal of Rheumatology, May 1995:22(5):953 European Journal of Pharmacology, Sep. 2004: 504(1):217-222. 958. Kwon, et al. “Magnesium Chloride in a Polyethylene Glycol Tramer, M.R. et al., Magnesium bier's block for treatment of Formulation as a Neuroprotective Therapy for Acute Spinal Cord Chronic limb pain: a randomised, double-blind, cross-over study, Injury: Preclinical Refinement and Optimization.” Journal of Pain, Sep. 2002:99(1-2):235-241. Neurotrauma 26, 1379-1393 (Aug. 2009). Turner, R.J. et al., Magnesium Gluconate Offers No More Protec Kwon, et al. “A Grading System to Evaluate Objectively the tion than Magnesium Sulphate Following Diffuse Traumatic Brain Strength of Pre-Clinical Data of Acute Neuroprotective Therapies Injury in Rats, Jounal of the American College of Nutrition, Oct. for Clinical Translation in Spinal Cord Injury,” Journal of 2004:23(5):541S-544S. Neurotrauma, 28, 1525-1543 (Aug. 2011). Vink R. et al., Pharmacological and physiological effect of magne Kwon, et al. “Translational Research in Spinal Cord Injury: A sium on experimental traumatic brain injury, Magnesium Research, Survey of Opinion from the SCI Community,” Journal of Sep. 1990:3(3):163-169. Neurotrauma, 27, pp. 21-33 (Jan. 2010). Muir et al., Magnesium for acute stroke (Intravenous Magnesium McKee, et al. “Analysis of the Brain Bioavailability of Peripherally Efficacy in Stroke trial): randomised controlled trial. The Lancet, Administered Magnesium Sulfate: A Study in Humans with Acute Feb. 2004:363(94.07):439-445. Brain Injury Undergoing Prolonged Induced Hypermagnesemia,” Saver, J.L. et al., Prehospital Neuroprotective Therapy for Acute Crit. Care Med., 33(3), 661-666 (Mar. 2005). Stroke: Results of the Field Administration of Stroke Therapy Journal of Spinal Cord Medicine, 34(6), 620-621 (2011). Magnesium (FAST-MAG) Pilot Trial, Stroke, Mar. 2004:35(5):106 108. * cited by examiner U.S. Patent Jun. 13, 2017 Sheet 1 of 5 US 9,675,696 B2 FIG.1 HO-- (CH-O-CH--OH H l U.S. Patent Jun. 13, 2017 Sheet 2 of 5 US 9,675,696 B2 FG. 2 U.S. Patent Jun. 13, 2017 Sheet 3 of 5 US 9,675,696 B2 Polyoxyethylene sorbitan monoester -h-irrO --h- -N- W Polyoxyethylene sorbitan triester U.S. Patent Jun. 13, 2017 Sheet 4 of 5 US 9,675,696 B2 FIG. 4 O O-CH-Cl, Poly(lactide) O O-CH-C Poly(glyco?ide) O H O || | || Om b.Cam C. OmrCwm C t Poly(lactide-co-glycolide) O-(CH)-o-Ci Polycapirolactone -- o-e- O CHs. t Poly(actlde-co-capfolactone) U.S. Patent Jun. 13, 2017 Sheet S of 5 US 9,675,696 B2 FIG.S US 9,675,696 B2 1. 2 METHOD AND USE FOR INCREASING Sci., 88, p. 8072 (1991); Ferguson, et al., J. Immunol. 150, EFFICACY OF ANT-ADHESIVE p. 1172 (1993). Results of in vivo experiments suggest that COMPOSITIONS IN CONTROLLING the inhibition of VLA-4-dependent cell adhesion should NFLAMMATION AND PAIN prevent, inhibit or alter several inflammatory and autoim mune pathologies.
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