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(12) United States Patent (10) Patent No.: US 9.446,029 B2 Boscan Et Al

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(12) United States Patent (10) Patent No.: US 9.446,029 B2 Boscan Et Al USOO9446O29B2 (12) United States Patent (10) Patent No.: US 9.446,029 B2 BOScan et al. (45) Date of Patent: Sep. 20, 2016 (54) USE OF NK-1 RECEPTOR ANTAGONISTS IN GB 2216529 10, 1989 MANAGEMENT OF VISCERAL PAIN WO 9102745 A1 3, 1991 WO 911226.6 A1 8, 1991 (75) Inventors: Pedro Boscan, Bellvue, CO (US); WO O11801.6 A1 3, 2001 David Twedt, Fort Collins, CO (US) OTHER PUBLICATIONS (73) Assignee: Colorado State University Research Glerum et al. (Veterinary Surgery, 30, 351-358, 2001).* Foundation, Fort Collins, CO (US) Devitt et al. (JAVMA, 227, 6, Sep. 15, 2005).* Papich (Veterinary Pharmacology and Therapeutics, Ninth Edition, (*) Notice: Subject to any disclaimer, the term of this 2009, p. 1247-1272, editors: Jim E. Riviere Mark G. Papich).* patent is extended or adjusted under 35 Bradesi et al. (Gastroenterology, 2006, 130, 1729-1742).* U.S.C. 154(b) by 452 days. Heard, D.J. et al. Effect of acepromazine on the anesthetic require ment of halothane in the dog, AJVR, 1986, pp. 2113-2115, vol. 47. (21) Appl. No.: 13/192.283 No. 10. Hellyer, P.W. et al. Effects of diazepam and flumazenil on minimum alveolar concentrations for dogs anesthetized with isoflurane or a (22) Filed: Jul. 27, 2011 combination of isoflurane and fentanyl, AJVR, 2001, pp. 555-560, (65) Prior Publication Data vol. 62, No. 4. Muir, W.W. III, et al. Effects of morphine, lidocaine, ketamine, and US 2012/002898O A1 Feb. 2, 2012 morphine-lidocaine-ketamine drug combination on minimum alveolar concentration in dogs anesthetized with isoflurane, AJVR, Related U.S. Application Data 2003, pp. 1155-1160, vol. 64, No. 9. Murphy, M.R. and Hug, C. C. Jr., The Enflurane Sparing Effect of (60) Provisional application No. 61/368,102, filed on Jul. Morphine, Butorphanol, and Nalbuphine, Anesthesiology, 1982, pp. 27, 2010, provisional application No. 61/478,189, 489-492, vol. 57. filed on Apr. 22, 2011. Pascoe, P.J. et al. Changes in the minimum alveolar concentration of isoflurane and some cardiopulmonary measurements during three (51) Int. Cl. continuous infusion rates of dexmedetomidine in dogs, Veterinary A 6LX 3/535 (2006.01) Anaesthesia and Analgesia, 2006, pp. 97-103, vol. 33. ADIN 43/9 (2006.01) Pypendop, B.H. et al. Characteristics of the relationship between plasma ketamine concentration and its effect on the minimum A6 IK 3/44 (2006.01) alveolar concentration of isoflurane in dogs, Veterinary Anaesthesia A 6LX 3L/2197 (2006.01) and Analgesia, 2007, pp. 209-212, vol. 34. A6 IK 3/439 (2006.01) Steffey, E.P. et al. Influence of Inhaled Anesthetics on the A6 IK 3/496 (2006.01) Pharmacokinetics and Pharmacodynamics of Morphine, Anesth A 6LX 3/5.377 (2006.01) Analg, 1993, pp. 346-351, vol. 77. (52) U.S. Cl. Valverde, A. et al. Effect of lidocaine on the minimum alveolar CPC ........... A61K 31/439 (2013.01); A61K 31/496 concentration of isoflurane in dogs, Veterinary Anaesthesia and Analgesia, 2004, pp. 264-271, vol. 31. (2013.01); A61 K3I/5377 (2013.01) Yamashita, K. et al. Effects of Carprofen and Meloxicam with or (58) Field of Classification Search without Butorphanol on the Minimum Alveolar Concentration of CPC ............. A61K 31/439; A61K 31/496; A61 K Sevoflurane in Dogs, J. Vet. Med. Sci., 2008, pp. 29-35, vol. 70, No. 3 1/5377 1. USPC ................................. 514/236.2, 305, 253.01 Ishizaki, K., et al., Intrathecal Neurokinin-1 Receptor Antagonist See application file for complete search history. Reduces Isoflurane MAC in Rats, 44.5 Can J Anaesth pp. 543-549, (1997). (56) References Cited Stevenson, G.W., et al., Targeting Pain-Depressed Behaviors in Preclinical Assays of Pain and Analgesia. Drug Effects on Acetic U.S. PATENT DOCUMENTS Acid-Depressed Locomotor Activity in ICR Mice, 85 Life Sci. 309, Abstract (2009). 4,839,465. A 6/1989 Singh et al. 5,576,317 A 11/1996 Gonsalves * cited by examiner 5,691,336 A 11/1997 Dorn et al. 5,719,147 A 2f1998 Dorn et al. 6,096,742 A 8, 2000 Crocker et al. Primary Examiner — Uma Ramachandran 6,387.925 B1 5/2002 Quallich et al. (74) Attorney, Agent, or Firm — Polsinelli PC 2005/0256164 A1* 11, 2005 O'Neill et al. 514/317 2007/0129328 A1* 6/2007 Boettner et al. ................ 514/58 (57) ABSTRACT 2007/O155782 A1 7/2007 Hickman et al. 2009.0099364 A1 4/2009 Basford et al. Methods for managing visceral pain in mammalian Subjects 2009, 0221641 A1* 9, 2009 Janssens et al. .............. 514,322 are described, in which a NK-1 receptor antagonist is administered to the Subject before, during or after adminis FOREIGN PATENT DOCUMENTS tration of general anesthesia. The methods and uses of NK-1 receptor antagonists described herein provide improved vis EP 0284.942 A2 10, 1988 EP O327009 A1 8, 1989 ceral pain management and MAC reduction when used with EP O4467O6 A2 9, 1991 Volatile anesthetics for general anesthesia. EP O482539 A2 4f1992 EP O484719 A2 5, 1992 15 Claims, 7 Drawing Sheets U.S. Patent Sep. 20, 2016 Sheet 1 of 7 US 9,446,029 B2 afiequeºuedA3Sgoºueungo uo?equeºuo'o(Oº?) © GLO Control Maropitant Maropitant 1 mg/kg 5 mg/kg F.G. 1 U.S. Patent Sep. 20, 2016 Sheet 2 of 7 US 9,446,029 B2 isoflurane Requirements During Owarian Ligament Ligation for Spay Surgery in Dogs s 3.5- 5 30 i 2.5- 2.0- 10 0.5- Control Morphine Maropitant FG 2 U.S. Patent Sep. 20, 2016 Sheet 3 of 7 US 9,446,029 B2 Heart Rate During Owarian Ligament Ligation for Spay Surgery in Dogs : --- Control Morphine Maropitant FG 3 U.S. Patent Sep. 20, 2016 Sheet 4 of 7 US 9.446,029 B2 Isoflurane Requirements During Skin Closure after Spay Surgery 2. O 1. 5. 1. O O. 5. O. O Controlsalasasasasas F.G. 4 U.S. Patent Sep. 20, 2016 Sheet S of 7 US 9,446,029 B2 Heart Rate During Skin Closure after Spay Surgery in Dogs 160 Control Morphine Maropitant F.G. 5 U.S. Patent Sep. 20, 2016 Sheet 6 of 7 US 9,446,029 B2 Visual Analogue Pain Scale in Dogs after Spay Surgery SS 3.o 2.50 150 100 050: Before POSt Pemec Omn 15min 30min 60min 90min 120min 180mln F.G. 6 U.S. Patent Sep. 20, 2016 Sheet 7 of 7 US 9,446,029 B2 Sevoflurane MAC Determination in Cats During Ovary and Ovarian Ligament Stimulation 3 2 O O US 9,446,029 B2 1. 2 USE OF NK-1 RECEPTOR ANTAGONSTS IN ciated with cancer chemotherapy. The NK-1 receptor MANAGEMENT OF VISCERAL PAIN antagonist maropitant (available from Pfizer as Cerenia(R), is an NK-1 receptor antagonist that is approved for use as an RELATED APPLICATION INFORMATION antiemetic in dogs. This application claims the benefit of U.S. provisional SUMMARY OF THE INVENTION application No. 61/368,102 filed Jul. 27, 2010, and U.S. provisional application No. 61/478,189, filed Apr. 22, 2011, In one aspect, the present disclosure provides a method of the entire disclosures of which are herein incorporated by providing visceral analgesia in a mammalian Subject in need reference. 10 thereof, the method comprising administering to the Subject a therapeutically effective amount of a composition com TECHNICAL FIELD prising a NK-1 receptor antagonist, a pharmaceutically acceptable salt thereof, a prodrug of the NK-1 receptor The present disclosure relates generally to methods for antagonist or pharmaceutically acceptable salt thereof, or a managing pain, and in particular to methods for managing 15 solvate or hydrate of the NK-1 compound, of the NK-1 visceral pain in mammals. receptor antagonist or of the pharmaceutically acceptable salt thereof. BACKGROUND OF THE INVENTION In another aspect, the present disclosure provides a method for providing visceral analgesia to a mammalian Volatile anesthetics are commonly used to achieve the 20 Subject in need thereof, the method comprising administer appropriate plane of anesthesia in human and Veterinary ing to the Subject prior, during or after an administration of Surgical patients. Volatile anesthetics are however costly and general anesthesia to the Subject, a therapeutically effective have certain side effects such as reducing vascular resistance amount of a composition comprising a NK-1 receptor and resulting hypotension. It therefore can be desirable to antagonist, a pharmaceutically acceptable salt thereof, a reduce the amount, typically determined as minimum alveo- 25 prodrug of the NK-1 receptor antagonist orpharmaceutically lar concentration or "MAC", of the volatile anesthetic acceptable salt thereof, or a solvate or hydrate of the NK-1 needed during painful procedures through use of a MAC compound, of the NK-1 receptor antagonist or of the phar reducing agent. Known MAC reducing agents include opi maceutically acceptable salt thereof. ates such as morphine and fentanyl, ketamine, lidocaine and In the above methods, an exemplary NK-1 containing dexmedetomidine. 30 composition is a non-opioid composition. Opioid compounds in particular are capable of dramatic In another aspect, the present disclosure provides a MAC reductions of 50% and higher. For example, morphine method of improving visceral analgesia in a mammalian is currently used as a standard MAC reduction agent in the Subject in need thereof under general anesthesia, the method veterinary field. The use of morphine and other opioids comprising: administering to the Subject prior, during or however incurs numerous disadvantages related to the fact 35 after an administration of the general anesthesia, a thera that these substances are highly addictive and thus are peutically effective amount of a non-opioid composition classified as controlled Substances under DEA regulations.
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