USOO8846770B2

(12) Unlted States Patent (10) Patent N0.: US 8,846,770 B2 Lichter et a]. (45) Date of Patent: Sep. 30, 2014

(54) CONTROLLED RELEASE AURAL PRESSURE 6,740,664 B2 5/2004 Cagle et a1. MODULATOR COMPOSITIONS AND 7,001,615 B1 2/2006 Slngh etal METHODS FOR THE TREATMENT OF OTIC 3% ?f?jjfgfgfl' DISORDERS 2003/0092776 A1 5/2003 Ron et al. 2003/0229333 A1 12/2003 Ashton (75) Inventors: Jay Lichter, Rancho Santa Fe, CA (US); 2004/0082509 A1 4/2004 Bonny Benedikt Vollrath San Diego C A (US)- 2004/0101560 A1 5/2004 Sawchuk et a1. - I ’ - ’ . ’ 2005/0147585 A1 7/2005 Schwarz sefglo G“ Dufon’ san D1880, CA ws)’ 2005/0214338 A1 9/2005 Guitton et al. Michael ChI‘lStOPhel‘ Scalfe, LOS AITOS, 2006/0013858 A1 1/2006 Trune CA (U S); Fabrice Pill, San Diego, CA 2006/0046970 A1 3/2006 Bowman et al. (US); Qiang Ye, San Diego, CA (U S); 2006/0063802 A1 3/2006 Guitton et a1. Luis A. Dellamary, San Marcos, CA 1150b1§t 11151 (US)’. Carl Lebel’ Mahbu’' CA wS)’. 2007/0178051 A1 8/2007 Pruittasc ete a1. . Andrew M- Trammel, Olathe, KS (Us); 2008/0103118 A1 5/2008 Clement et al. Jeffrey P. Harris, La Jolla, CA (US) 2011/0166060 A1 7/2011 Simons et al. (73) Assignees: Otonomy, Inc., San Diego, CA (US); FOREIGN PATENT DOCUMENTS The Regents of the University of California, Oakland, CA (Us) W0 WO 97/38698 10/1997 W0 WO 99/24051 5/1999 * ( * ) Notice: patentSubject is to extendedany disclaimer, or adjusted the term under of this 35 W0 W0 03/034979 5/2003 U.S.C. 154(b) by 448 days. W0 W0 03/071986 9/2003 W0 WO 2006/099325 9/2006 (21) APPL NO; 12/486 697 W0 WO 2007/031098 3/2007 ’ W0 WO 2007/031280 3/2007 . W0 WO 2007/037874 4/2007 (22) Flledi J‘m- 17’ 2009 W0 WO 2007/037886 4/2007 W0 WO 2007/038949 4/2007 (65) Prior Publication Data WO WO2008001341 * 1/2008 W0 WO 2008/076556 6/2008 US 2010/0004225 A1 Jan. 7, 2010 OTHER PUBLICATIONS Related US, Application Data Song et. al., Bioorganic & Medicinal Chemistry Letters, 2003, _ _ _ _ Pergamon, vol. 13, pp. 297-300.* (60) PrOV151onal application No. 61/073,716, ?led on Jun. Dounnishev et a1” “waardenburg Syndrome,» Intl J Dermatol 18, 2008, provisional application No. 61/074,583, 39656-663 (1999), ?led on Jun, 20; 2008; provisional application NO_ Hall et al., “Anti-Pneumocystis Activities of Aromatic Diamidoxine 61/082,450, ?led on Jul. 21, 2008, provisional Is’ro?img?” A?timi?ofial 1252;56‘246C611731Tiglgglpyt 1993, American - - oclety 0r lcro 10 ogy : - . app11cat10n NO' .61/.086’105’ ?led on Aug' 4’ 2008’ McCarthy et al., “Alport syndrome: a review,” Clinical Eye and prOV151onal app11cat10n No. 61/094,384, ?led on Sep. Vision Care 12:139_150(2000)‘ 4, 2008: PYOVISIOHZ11 applicatlo'n NO- 61/191>1_12> ?led Nance et al., “The Genetics of Deafness,” Mental Retardation and on Sep. 29, 2008, provmonal app11cat10n No. Developmental Disabilities, 2003, Wiley-Liss, vol. 9, pp. 109-119. 61/140,033, ?led on Dec, 22, 2008~ Salt et al., “Local Inner Drug Delivery and Pharmacokinetics,” Drug Discovery Today 10(19): 1299-1306 (2005). (51) Int Cl U.S. Appl. No. 12/466,310 Of?ce Action mailed Jan. 12,2011. I I Karolewicz and Pluta, “Thermo sensitive polymers in drug form tech A61K 47/30 (200601) nology II. Possibilities of use of thermosensitive polymers as active A61K 9/14 (200601) substance carriers,” Polimery W Medycynie 38(1):15-26, 2008 A61K 31/724 (2006.01) (English language abstract). (52) US. Cl. . CPC ...... A61K 31/724 (2013.01) (Commued) USPC ...... 514/772.3; 424/489 Primary Examiner i Sarah Pihonak (58) Fleld 0f ClaSSI?catlon SearCh (74) Attorney, Agent, orFirm * Wilson Sonsini Goodrich& USPC ...... 514/772.3; 424/489 Rosati See application ?le for complete search history. (57) ABSTRACT (56) References Cited Disclosed herein are compositions and methods for the treat U.S. PATENT DOCUMENTS ment of otic diseases or conditions With aural pressure modu lating agent compositions and formulations administered 4,478,822 A 10/1984 Haslam et a1. locally to an individual afflicted Wit