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(12) United States Patent (10) Patent No.: US 9,333,171 B2 Lichter Et Al

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(12) United States Patent (10) Patent No.: US 9,333,171 B2 Lichter Et Al US009333171B2 (12) United States Patent (10) Patent No.: US 9,333,171 B2 Lichter et al. (45) Date of Patent: *May 10, 2016 (54) CONTROLLED-RELEASECNS A647/4 (2006.01) MODULATING COMPOSITIONS AND A647/38 (2006.01) METHODS FOR THE TREATMENT OF OTC A647/44 (2006.01) DSORDERS A 6LX3/97 (2006.01) (52) U.S. Cl. (71) Applicants: Otonomy, Inc. San Diego, CA (US); CPC ................. A61 K9/0046 (2013.01); A61 K9/06 Gis they of (2013.01); A61 K3I/00 (2013.01); A61 K s s 31/167 (2013.01); A61K 31/195 (2013.01); (72) Inventors: Jay Lichter, Rancho Santa Fe, CA (US); A6 IK31/197 (2013.01); A61 K3I/5513 Andrew M. Trammel, Olathe, KS (US); (2013.01); A61K 45/06 (2013.01); A61K47/10 FabriceO Piu,TO San Diego, CA (US); (2013.01); A61(2013.01); K47/14 (2013.01);A61 K47744 A61K47/38 (2013.01) Qiang Ye, San Diego, CA (US); Michael • u. fs Christopher Scaife, Los Altos, CA (58) Field of Classification Search (US); Benedikt Vollrath, San Diego, CA None (US); Sergio G. Duron, San Diego, CA See application file for complete search history. (US); Luis A. Dellamary, San Marcos, CA (US); Carl Lebel, Malibu, CA (US); Jeffrey P. Harris, La Jolla, CA (US) (56) References Cited (73) Assignees: OTONOMY, INC., San Diego, CA U.S. PATENT DOCUMENTS (US): THE REGENTS OF THE 4,478,822. A 10/1984 Haslam et al. UNIVERSITY OF CALIFORNLA, 5,292,516 A * 3/1994 Viegas et al. ................. 424/423 Oakland, CA (US) 5,503,848 A 4/1996 Perbellini et al. 5,861,174 A 1/1999 Stratton et al. (*) Notice: Subject to any disclaimer, the term of this 86. R 58: S.E. al patent is extended or adjusted under 35 6,316,011 B1 1 1/2001 Ron et al. U.S.C. 154(b) by 0 days. 6,392,036 B1 5/2002 Karlsson et al. 6,649,621 B2 11/2003 Kopke et al. This patent is Subject to a terminal dis- 6,740,664 B2 5/2004 Cagle et al. claimer. 7,001,615 B1 2/2006 Singh et al. 7,524,834 B2 4/2009 Karlsson et al. (21) Appl. No.: 14/300,011 8,318,817 B2 11/2012 Lichter et al. ................. 514,772 8,349,353 B2 * 1/2013 Lichter et al. ................. 424/437 (22) Filed: Jun. 9, 2014 (Continued) (65) Prior Publication Data FOREIGN PATENT DOCUMENTS US 2014/03092.17 A1 Oct. 16, 2014 WO WO97/38698 10, 1997 WO WO99,24051 5, 1999 Related U.S. Application Data (Continued) (63) Continuation of application No. 13/425,217, filed on Mar. 20, 2012, now Pat. No. 8,852,626, which is a OTHER PUBLICATIONS origippi. N. 12/494,156, filed on Ahn etal. Lipoic acid rescues DBA mice from early-onset age-related • 1-1 s s hearing impairment. Neuroreport 19(13): 1265-9. 2008. (60) Provisional application No. 61/076,567, filed on Jun. (Continued) 27, 2008, provisional application No. 61/082,450, filed on Jul. 21, 2008, provisional application No. fo Sp i. d s Pys Primary Examiner — Hasan Ahmed provisionalapplicauon applicationNo. No., 112, 61/140,033, Illed on Sep. filed Z9, on Dec.s torney Agent, or Firm — Wilson Sonsini, Goodrich 22, 2008, provisional application No. 61/164,812, filed on Mar. 30, 2009. (57) ABSTRACT (51) Int. Cl. A6DF 9/02 (2006.01) Disclosed herein are compositions and methods for the treat A6 IK9/00 (2006.01) ment of otic disorders with CNS modulating agent composi A6 IK9/06 (2006.01) tions and compositions administered locally to an individual A6 IK3I/00 (2006.01) afflicted with an otic disorder, through direct application of A6 IK3I/67 (2006.01) these compositions and compositions onto or via perfusion A 6LX3L/95 (2006.01) into the targeted auris structure(s). A 6LX3/553 (2006.01) A6 IK 45/06 (2006.01) A6 IK 47/10 (2006.01) 15 Claims, 4 Drawing Sheets US 9,333,171 B2 Page 2 (56) References Cited Chen et al. Design and preparation of thermosensitive in situ gel of dexamethasone sodium phosphate. J Guangdong Coll Pharm U.S. PATENT DOCUMENTS 23(5):518-21. 2007 (English abstract). Chen et al. Evaluation of thermosensitive in situ gel using dynamic 8,399,018 B2 * 3/2013 Lichter et al. ................. 424/484 rheological experiment. Chin Pharm J43(6):444-447. 2008 (English 8,496.957 B2* 7/2013 Lichter et al. .. ... 424/437 8,648,119 B2 * 2/2014 Lichter et al. .............. 514,772.6 abstract). 8,784,870 B2 * 7/2014 Lichter et al. ................. 424/437 Chen et al. In vivo distribution and pharmacokinetics of 2002/0045668 A1 4/2002 Dang et al. dexamethasone sodium phosphate thermosensitive in situ gel follow 2003/0092776 A1 5, 2003 Ron et al. ing intratympanic injection. Sichuan Da Xue Xue Bao Yi Xue Ban 2003/0229333 A1* 12/2003 Ashton et al. ................. 604,514 37(3):456-9. 2006 (English translation). 2004/0082.509 A1 4/2004 Bonny Chen et al. Preparation and characterization of dexamethasone 2004/0101560 A1* 5, 2004 Sawchuk et al. .............. 424/486 2005, 0147585 A1 7, 2005 Schwarz acetate-loaded solid lipid nanoparticles. Chinese.JPharm 39(4):261 2005/O152982 A1 7/2005 Appel et al. 264. 2008 (English abstract). 2005/0214338 A1 9, 2005 Guitton et al. Chen et al. Study on dexamethasone thermosensitive in situ gel for 2006, OO13858 A1 1/2006 Trune treating deafness. Chin Pharm J 41 (9):685-688. 2006 (English 2006, 0046970 A1 3/2006 Bowman et al. abstract). 2006, OO638O2 A1 3, 2006 Guitton et al. CIPRODEX. product label. 2009. 2006/0205789 A1* 9, 2006 Loblet al. ..................... 514/326 Couloigner et al. The Laryngoscope. The American Laryngological. 2006/0264897 A1 11, 2006 Loblet al. 2006/0269602 A1 11/2006 Dasch et al. Rhinological, and Otological Society. 108:592-598. 1998. 2007/01 10788 A1 5/2007 Hissong et al. Deflorio et al. The Journal of Emergency Medicine. 2006. Elsevier. 2007/0178051 A1 8, 2007 Pruitt et al. 31(4):377-379. 2008. O103118 A1 5, 2008 Clement et al. Derin et al. The effects of L-carnitine on presbyacusis in the rat 2009,0297533 A1 12, 2009 Lichter et al. model. Clin Otolaryngol Allied Sci 29(3):238-41, 2004. 2009,0306225 A1 12, 2009 Lichter et al. Dourmishev et al. Waardenburg syndrome. Intl J Dermatol 39:656 2009/0324552 A1 12, 2009 Lichter et al. 2009/0325938 A1 12, 2009 Lichter et al. 663 (1999). 2010, 0004225 A1 1/2010 Lichter et al. Endo et al. Novel strategy for treatment of inner ears using a biode 2010, OOO9952 A1 1/2010 Lichter et al. gradable gel. Laryngoscope 115(11):2016-20, 2005. 2010, OO15228 A1 1/2010 Lichter et al. Feng et al. Effect of poloxamer 407 on the middle ear and inner ear 2010, OO15263 A1 1/2010 Lichter et al. after regional perfusion in guineas pigs. Zhonghua er Bi Yan Hou Tou 2010, OO16218 A1 1/2010 Lichter et al. Jing Wai Ke Za Zhi, Jun. 2007 42(6):443-6 (English Abstract). 2010, OO16450 A1 1/2010 Lichter et al. Feng et al. In vitro and in vivo biodegradation of Sustained-release 2010, 0021416 A1 1/2010 Lichter et al. 2010.0022661 A1 1/2010 Lichter et al. vehicle polozamer 407 in situ gel. Zhonghua Yi Xue Za Zhi. Aug. 28, 2010.0036000 A1 2/2010 Lichter et al. 2007, 87(32):2289-91 (English Abstract and Translation). 2010, O197800 A1 8/2010 Friedman et al. Fernandez et al. Self-curing controlled release systems for steroids. 2011 0166060 A1 7, 2011 Simons et al. Application of prednisolone-based polymeric systems to ear dis 2012fO190671 A1 7, 2012 Lichter et al. eases. Biomaterials 26(16):3311-8. 2005. Friedman et al. GRM7 variants confer susceptibility to age-related FOREIGN PATENT DOCUMENTS hearing impairment. Hum Mol Genet 18(4):785-96. 2009. Garduno-Anaya et al. Dexamethasone inner ear perfusion by WO WO99,321.51 7, 1999 intratympanic injection in unilateral Ménière's disease: a two-year WO WO O2/O56890 A1 T 2002 prospective, placebo-controlled, double-blind, randomized trial. WO WOO3,O34979 5, 2003 Otolaryngol Head Neck Surg 133(2):285-94. 2005. WO WOO3,O17990 6, 2003 WO WOO3,O71986 9, 2003 GB0823378.5 combined search and examination report dated Feb. WO WO 2006/099325 9, 2006 24, 2009. WO WO 2007/031098 3, 2007 GB0823378.5 Examination Report dated Oct. 23, 2009. WO WO 2007/031280 3, 2007 GB0907065.7 combined search and examination report dated Nov. WO WO 2007/037874 4/2007 16, 2009. WO WO 2007/037886 4/2007 GB0912650.9 combined search and examination report dated Oct. WO WO 2007/038949 4/2007 23, 2009. WO WO 2007/089490 8, 2007 Gubbels et al. Functional auditory hair cells produced in the mam WO WO 2008/076.556 6, 2008 malian cochlea by in utero gene transfer. Nature 455(7212):537-41. 2008. OTHER PUBLICATIONS Guyot et al. Intratympanic application of an antiviral agent for the Arnold et al. Novel slow- and fast-type drug release round-window treatment of Ménière's disease. ORL J Otorhinolaryngol Relat Spec microimplants for local drug application to the cochlea: an experi 70(1):21-6; discussion 26-7. 2008. mental study in guinea pigs. Audiol Neurootol 10(1):53-63. 2005. Hall et al. Anti-Pneumocystis Activities of Aromatic Diamidoxine Auris Medical. press release reporting initiating of phase I/II clinical Prodrugs. Antimicrobial Agents & Chemotherapy. 1998. American trial with AM-101.
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