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(12) United States Patent (10) Patent No.: US 8.496,957 B2 Lichter Et Al

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(12) United States Patent (10) Patent No.: US 8.496,957 B2 Lichter Et Al US008496957B2 (12) United States Patent (10) Patent No.: US 8.496,957 B2 Lichter et al. (45) Date of Patent: Jul. 30, 2013 (54) CONTROLLED RELEASE AURISSENSORY (30) Foreign Application Priority Data CELL MODULATOR COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTC Apr. 24, 2009 (GB) ...................................... 0907070 DSORDERS (51) Int. Cl. (75) Inventors: Jay Lichter, Rancho Santa Fe, CA (US); 469/14 (2006.01) Benedikt Vollrath, San Diego, CA (US); A613 L/47 (2006.01) Sergio G. Duron, San Diego, CA (US); A 6LX3/57 (2006.01) Carl Lebel, Malibu, CA (US); Fabrice (52) U.S. Cl. Piu, San Diego, CA (US); Qiang Ye, San USPC ........ 424/437; 424/489: 514/266.1: 514/312: Diego, CA (US); Luis A. Dellamary, 5147646 San Marcos, CA (US); Andrew M. (58) Field of Classification Search Trammel, Olathe, KS (US); Michael None Christopher Scaife, Los Altos, CA See application file for complete search history. (US); Jeffrey P. Harris, La Jolla, CA (56) References Cited (US) (73) Assignees: Otonomy, Inc, San Diego, CA (US); U.S. PATENT DOCUMENTS The Regents of the University of 4,478,822. A 10/1984 Haslam et al. California, Oakland, CA (US) 5,292,516 A 3/1994 Viegas et al. (*) Notice: Subject to any disclaimer, the term of this (Continued) patent is extended or adjusted under 35 FOREIGN PATENT DOCUMENTS U.S.C. 154(b) by 652 days. CA 2268.331 5, 1998 CN 1.01134780 3, 2008 (21) Appl. No.: 12/504,553 (Continued) (22) Filed: Jul. 16, 2009 OTHER PUBLICATIONS Doleviczenyi et al., “Cochlear dopamine release is modulated by (65) Prior Publication Data group II metobotropic glutamate receptors via GABAergic US 201O/OO15263 A1 Jan. 21, 2010 neurotransmission.” Neuroscience Ltrs 385:93-98 (2005). (Continued) Related U.S. Application Data Primary Examiner — Jeffrey E. Russel (60) Provisional application No. 61/082,450, filed on Jul. (74) Attorney, Agent, or Firm — Wilson, Sonsini, Goodrich 21, 2008, provisional application No. 61/083,830, & Rosati filed on Jul. 25, 2008, provisional application No. (57) ABSTRACT 61/086,094, filed on Aug. 4, 2008, provisional application No. 61/094,384, filed on Sep. 4, 2008, Disclosed herein are methods for the treatment of otic dis provisional application No. 61/101,112, filed on Sep. eases or conditions with intratympanic compositions and for 29, 2008, provisional application No. 61/140,033, mulations of multiparticulate auris sensory cell modulating filed on Dec. 22, 2008, provisional application No. agent administered locally to an individual afflicted with an 61/160,233, filed on Mar. 13, 2009, provisional otic disease or condition, through direct application of these application No. 61/164,812, filed on Mar. 30, 2009, compositions and formulations onto or via perfusion into the provisional application No. 61/174,421, filed on Apr. targeted auris structure(s). 30, 2009. 13 Claims, 5 Drawing Sheets 1000 100 -------A------------------------------------------- Non-micronized otic agent O Solution Micronized otic agent solution Non-micronized otic agenth gelling agent Micronized otic agent+ gelling agent Time (days) US 8,496.957 B2 Page 2 U.S. PATENT DOCUMENTS U.S. Appl. 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Auris Medical, press release reporting results of phase I/II clinical 2003,0229333 A1 12/2003 Ashton trial with AM-111, Jun. 21, 2006. 2004/0082.509 A1 4/2004 Bonny Battaglia et al., “Combination therapy (intratympanic 2004/0101560 A1 5, 2004 Sawchuk et al. dexamethasone + high-dose prednisone taper) for the treatment of 2004/0192763 A1 9, 2004 Chenard et al. idiopathic sudden sensorineural hearing loss.” Otol Neurotol 2005, 0147585 A1 7, 2005 Schwarz 29(4):453-60, 2008. 2005/0214338 A1 9, 2005 Guitton et al. Campbell et al., “Oral-D-methionine (MRX-1024) significantly pro 2006, OO13858 A1 1/2006 Trune tects against cisplatin-induced hearing loss: a phase II study in 2006, 0046970 A1 3/2006 Bowman et al. humans.” Abst 32". Ann MidWinter Res Meeting. ARO Abstracts 2006, OO638O2 A1 3, 2006 Guitton et al. 32:7, Feb. 14-19, 2009. 2006, OO74083 A1 4/2006 Kalvinish et al. Chen and Nathans, “Estrogen-related receptor beta/NR3B2 controls 2006/0205789 A1 9, 2006 Loblet al. epithelial cell fate and endolymph production by the stria vascularis.” 2006/0216353 A1 9/2006 Liversidge et al. 2006/0264897 A1 11/2006 Loblet al. Dev Cell 13(3):325-37, 2007. 2006/0269602 A1 11/2006 Dasch et al. Chen et al., “Design and preparation of thermosensitive in situ gel of 2007/0021352 A1 1/2007 Anderson et al. dexamethasone sodium phosphate. J Guangdong Coll Pharm 2007/0178051 A1 8, 2007 Pruitt et al. 23(5):518-21, 2007 (English abstract). 2007/02991 13 A1 12/2007 Kalvinish et al. Chen et al., “Evaluation of thermosensitive in situ gel using dynamic 2008/O103118 A1* 5/2008 Clement et al. ............... 514,169 rheological experiment.” Chin Pharm J. 43(6):444-447, 2008 2011 0166060 A1* 7/2011 Simons et al. ................. 514/2.8 (English abstract). Chen et al., “In vivo distribution and pharmacokinetics of FOREIGN PATENT DOCUMENTS dexamethasone sodium phosphate thermosensitive in situ gel follow EP 1107791 B1 6, 2001 ing intratympanic injection.” Sichuan Da Xue Xue Bao Yi Xue Ban GB 24599.10 11, 2009 37(3):456-9, 2006 (English translation). WO WO97/38698 10, 1997 Chen et al., "Preparation and characterization of dexamethasone WO WO99,24051 5, 1999 acetate-loaded solid lipid nanoparticles.” Chinese J Pharm WO WO-02-056890 A1 T 2002 WO WOO3,O34979 5, 2003 39(4):261-264, 2008 (English abstract). WO WOO3,O17990 6, 2003 Chen et al., “Study on dexamethasonethermosensitive in situ gel for WO WOO3,O71986 9, 2003 treating deafness.” Chin Pharm J 41 (9):685-688, 2006 (English WO WO 2006/099325 9, 2006 abstract). WO WO 2007/031098 3, 2007 CIPRODEX, product label, 2009. WO WO 2007/031280 3, 2007 Derin et al., “The effects of L-carnitine on presbyacusis in the rat WO WO 2007/037874 4/2007 model.” Clin Otolaryngol AlliedSci 29(3):238-41, 2004. WO WO 2007/037886 4/2007 Endo et al., “Novel strategy for treatment of inner ears using a WO WO 2007/038949 4/2007 biodegradable gel.” Laryngoscope 115(11):2016-20, 2005. WO WO-2007-045876 A1 4/2007 Feng et al., “Effect of poloxamer 407 on the middle ear and inner ear WO WO 2007 119098 10/2007 after regional perfusion in guinea pigs.” Zhonghua Er Bi Yan Hou Tou WO WO 2008/076.556 6, 2008 WO WO 2009/132050 10/2009 Jing Wai Ke Za Zhi 42(6):443-6, 2007 (English translation). WO WO-2010-048.095 A2 4/2010 Feng et al., “In vitro and in vivo biodegradation of Sustained-release WO WO-2010-048.095 A3 4/2010 vehicle poloxamer 407 in situ gel.” Lin Chung Er BiYan Hou Tou Jing Wai Ke Za Zhi 22(1):28-31, 2008 (English translation). OTHER PUBLICATIONS Fernandez et al., “Self-curing controlled release systems for steroids. Application of prednisolone-based polymeric systems to ear dis Dourmishev et al., “Waardenburg syndrome.” Intl J Dermatol eases.” Biomaterials 26(16):3311-8, 2005. 39.656-663 (1999). Friedman et al., “GRM7 variants confer susceptibility to age-related Hall et al., “Anti-Pneumocystis Activities of Aromatic Diamidoxine hearing impairment.” Hum Mol Genet 18(4):785-96, 2009. Prodrugs.” Antimicrobial Agents & Chemotherapy, 1998, American Garduno-Anaya et al., “Dexamethasone inner ear perfusion by Society for Microbiology 42(4):666-674 (1998). intratympanic injection in unilateral Ménière's disease: a two-year McCarthy et al., “Alport syndrome: a review.” Clinical Eye and prospective, placebo-controlled, double-blind, randomized trial.” Vision Care 12:139-150 (2000). Otolaryngol Head Neck Surg 133(2):285-94, 2005. Nance et al., “The Genetics of Deafness. Mental Retardation and Gubbels et al., “Functional auditory hair cells produced in the mam Developmental Disabilities, 2003, Wiley-Liss, vol. 9, pp. 109-119. malian cochlea by in uterogene transfer.” Nature 455(7212):537-41, Peng et al., “Group I metabotropic glutamate receptors in spiral 2008. Ganglion neutrons contribute to excitatory neurotransmissions in the Guyot et al., “Intratympanic application of an antiviral agent for the cochlea.” Neuroscience 123:221-230 (2004). treatment of Ménière's disease.” ORL J Otorhinolaryngol Relat Spec Salt et al., “Local Inner Ear Drug Delivery and Pharmacokinetics.” 70(1):21-6; discussion 26-7, 2008. Drug Discovery Today 10(19): 1299-1306 (2005). Hargunani et al., “Intratympanic injection of dexamethasone: time Suzuki et al., “Pharmacological Characterization of a New, orally course of inner ear distribution and conversion to its active form.” Active and Potent Allosteric Metabotropic Glutamate receptor 1 Otol Neurotol 27(4):564-9, 2006.
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