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(12) United States Patent (10) Patent No.: US 9.205,048 B2 Lichter Et Al

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(12) United States Patent (10) Patent No.: US 9.205,048 B2 Lichter Et Al USOO9205048B2 (12) United States Patent (10) Patent No.: US 9.205,048 B2 Lichter et al. (45) Date of Patent: *Dec. 8, 2015 (54) CONTROLLED RELEASE ANTIMICROBIAL (58) Field of Classification Search COMPOSITIONS AND METHODS FOR THE CPC A61 K9/0024; A61 K9/0046; A61K 31/497; TREATMENT OF OTC DSORDERS A61K 47/34 See application file for complete search history. (71) Applicants: Otonomy, Inc., San Diego, CA (US); The Regents of the University of California, Oakland, CA (US) (56) References Cited (72) Inventors: Jay Lichter, Rancho Santa Fe, CA (US); U.S. PATENT DOCUMENTS Andrew M. Trammel, Olathe, KS (US); 4,188,373 A 2, 1980 Krezanoski Fabrice Piu, San Diego, CA (US); 4,478,822 A 10, 1984 Haslam et al. Qiang Ye, San Diego, CA (US); Luis A. 4,938,763. A 7, 1990 Dunn et al. 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No.: 14/618,926 6,177,434 B1 1/2001 Kopke et al. 6,201,065 B1 3/2001 Pathak et al. 6,201,072 B1 3/2001 Rathi et al. (22) Filed: Feb. 10, 2015 6,239,113 B1 5, 2001 Dawson et al. (65) Prior Publication Data (Continued) US 2015/O150793 A1 Jun. 4, 2015 FOREIGN PATENT DOCUMENTS EP O551626 7, 1993 Related U.S. Application Data JP O7-215877 8, 1995 (63) Continuation of application No. 13/848,636, filed on (Continued) Mar. 21, 2013, which is a continuation of application No. 13/645,126, filed on Oct. 4, 2012, which is a OTHER PUBLICATIONS continuation of application No. 12/506,127, filed on Jul. 20, 2009, now Pat. No. 8,318,817, and a Ahn etal. Lipoic acid rescues DBA mice from early-onset age-related continuation-in-part of application No. 12/427,663, hearing impairment. Neuroreport 19(13): 1265-9. 2008. filed on Apr. 21, 2009, and a continuation-in-part of (Continued) application No. 12/466,310, filed on May 14, 2009, now Pat. No. 8,030,297. (60) Provisional application No. 61/082,450, filed on Jul. Primary Examiner — Sarah Pihonak 21, 2008, provisional application No. 61/083,871, (74) Attorney, Agent, or Firm — Wilson Sonsini Goodrich & filed on Jul. 25, 2008, provisional application No. Rosati 61/094,384, filed on Sep. 4, 2008, provisional application No. 61/101,112, filed on Sep. 29, 2008, provisional application No. 61/140,033, filed on Dec. (57) ABSTRACT 22, 2008. Disclosed herein are compositions and methods for the treat (51) Int. Cl. ment of otic diseases or conditions with antimicrobial agent A6 IK9/00 (2006.01) compositions and formulations administered locally to an A6 IK3I/496 (2006.01) individual afflicted with anotic disease or condition, through A6 IK 47/34 (2006.01) direct application of these compositions and formulations (52) U.S. Cl. onto or via perfusion into the targeted auris structure(s). CPC ............. A61 K9/0046 (2013.01); A61 K3I/496 (2013.01); A61 K9/0024 (2013.01); A61 K47/34 (2013.01) 11 Claims, 5 Drawing Sheets US 9.205,048 B2 Page 2 (56) References Cited JP 2006-111585 4/2006 WO WO97/38698 10, 1997 U.S. PATENT DOCUMENTS WO WO99,24051 5, 1999 WO WO99,321.51 7, 1999 6.284,804 B1 9/2001 Singh et al. WO WOOOO7603 2, 2000 6,287,588 B1 9/2001 Shih et al. WO WOOOf 50005 8, 2000 6,316,011 B1 1 1/2001 Ron et al. WO WO O2/O56890 T 2002 6,359,016 B2 3/2002 Singh et al. WO WOO3,O17990 3, 2003 6,392,036 B1 5/2002 Karlsson et al. WO WOO3,O34979 5, 2003 6,488,952 B1 12/2002 Kennedy et al. WO WOO3,051375 6, 2003 6,509,327 B1 1/2003 Cagle et al. WO WOO3,O71986 9, 2003 6,589,549 B2 7/2003 Shih et al. WO WO 2004/050O21 6, 2004 6,649,621 B2 11/2003 Kopke et al. WO WO 2006O29074 A2 * 3, 2006 6,740,664 B2 5/2004 Cagle et al. WO WO 2006/099325 9, 2006 7,001,615 B1 2/2006 Singh et al. WO WO 2006,102964 10, 2006 7,018,645 B1 3/2006 Piao et al. 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Schuk etal Auris Medical. press release reporting initiating of phase I/II clinical 2004/0204471 A1 10, 2004 Seibert trial with AM-101. Feb. 22, 2007. 2005, 0147585 A1 7, 2005 Schwarz Auris Medical. press release reporting results of phase I/II clinical 2005/0214338 A1 9, 2005 Guitton et al. trial with AM-111. Jun. 21, 2006. 2005/0287200 A1 12/2005 Murthy Battaglia et al. Combination therapy (intratympanic dexametha 2006, OO13858 A1 1/2006 Trune Sone + high-dose prednisone taper) for the treatment of idiopathic 29.8% A. 2299. ESAn etal Sudden sensorineural hearing loss. Otol Neurotol 29(4):453-60. 2006/0063802 A1 3f2006 Guitton et al. 2008. 2006, O257488 A1 11, 2006 Hubbard Bird et al. Intratympanic versus intravenous delivery of 2006/0264897 A1 11, 2006 Loblet al. methylprednisolone to cochlear perilymph. Otology & Neurotology 2006/0269602 A1 11/2006 Dasch et al. 28(8): 1124-1130, 2007. 2007/0048338 A1 3/2007 Ladd Campbell et al. Oral-D-methionine (MRX-1024) significantly pro 2007/01 10788 A1 5/2007 Hissong et al. tects against cisplatininduced hearing loss: a phase II study in 37.8% A. 38. SE humans. Abst 32nd Ann MidWinter Res Meeting. ARO Abstracts 2008/0.103118 A1 5/2008 Clement et al. 32.7 Feb. 14-19, 2009. 2008/O124385 A1 5/2008 Campbell Chang et al. Prolonged antifungal effects of clotrimazole-containing 2008. O181952 A1 7/2008 Vogel et al. mucoadhesive thermosensitive gels on vaginitis. J of Controlled 2008/0318918 A1 12/2008 Campbell et al. Release. 82:39-50 (2002). 2009/0093449 A1 4/2009 Bowman et al. Chen et al. Design and preparation of thermosensitive in situ gel of 3988SS A. 1858 West al. dexamethasone sodium phosphate. I Guangdong Coll Pharm 2009,0297533 A1 12, 2009 Lichter et al. 23(5):518-21. 2007 (English abstract). 2009,0306225 A1 12, 2009 Lichter et al. Chen et al. 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