Navigation Links
Otonomy Announces Preclinical Results Supporting Intra-operative Use of OTO-201 for Common Childhood Procedure
Date:6/8/2011

SAN DIEGO, June 8, 2011 /PRNewswire/ -- Otonomy, Inc., a developer of innovative therapeutics for diseases and disorders of the ear, today announced positive results for OTO-201, a sustained release gel formulation of the antibiotic ciprofloxacin, in multiple preclinical studies evaluating the treatment of middle ear effusion (fluid) at the time of tympanostomy tube placement surgery.  Approximately one million tube placement procedures are conducted each year in the U.S. with the vast majority performed in children suffering from recurrent or persistent otitis media (inflammation or infection of the middle ear). A significant portion of patients receiving tubes have middle ear effusion at the time of surgery which significantly increases their risk of post-operative complications including otorrhea (drainage) and tube occlusion. A number of clinical studies have demonstrated that administration of topical antibiotics during and immediately following tube placement surgery significantly reduces this risk. However, no antibiotic product has been approved by the United States Food and Drug Administration (FDA) for this use and efficacy relies on caregiver compliance with multi-day dosing regimens. OTO-201 is a sustained release antibiotic designed for intra-operative administration by the ear, nose and throat (ENT) surgeon, thereby providing a full course of treatment at the time of tube placement and eliminating the risk of compliance issues.

Preclinical study results demonstrating sustained middle ear drug exposure and efficacy of OTO-201 were presented yesterday at the 10th International Symposium on Recent Advances on Otitis Media. Data demonstrated that a single administration of OTO-201 delivered ciprofloxacin concentrations to the middle ear that were sustained for more than one week above the minimum inhibitory concentration (MIC) required for eradication of common otitis media pathogens. Findings in an otitis media model confirmed that OTO-201, when administered at the time of tube placement, achieved a significant reduction in both middle ear bacterial load and effusion volume versus the study's control treatment. In addition, a single dose of OTO-201 demonstrated middle ear drug levels and efficacy improvements that were comparable to fourteen doses (twice daily for seven days) of CIPRODEX®* Otic, the current market leading antibiotic eardrop.

"These positive results support the advancement of OTO-201 into clinical trials for a lead indication that is commercially attractive due to the large volume of tympanostomy tube placement procedures performed each year and the lack of an FDA-approved treatment," said David A. Weber, Ph.D., president and chief executive officer of Otonomy.  "Furthermore, we believe that the sustained release dosing profile and impressive microbiological efficacy demonstrated by OTO-201 in these preclinical studies may provide the opportunity to expand the set of target indications over time to include non-surgical patients suffering from chronic otitis media."

Based on these positive study results Otonomy plans to initiate a Phase 1b clinical trial of OTO-201 by the end of 2011 in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. The company is also actively advancing OTO-104, its lead product candidate, through clinical development as a treatment for Meniere's disease. By the end of 2011, Otonomy plans to discuss its recently announced positive Phase 1b data for OTO-104 with the FDA and initiate a Phase 2 clinical trial in Meniere's disease patients.

Otitis media is defined as an infection or inflammation of the middle ear and is extremely common during childhood.  It is typically the result of a viral, bacterial or respiratory infection that spreads into the middle ear.  According to the National Institute on Deafness and Other Communication Disorders (NIDCD), three out of four children experience otitis media by the time they reach three years of age.  Oral antibiotics are considered standard of care for patients with otitis media due to infection. Patients with recurrent or persistent otitis media are routinely referred to ENT surgeons for placement of a tympanostomy tube in one or both ears. Industry sources estimate that approximately one million patients undergo tympanostomy tube placement surgery each year in the U.S.

About OtonomyOtonomy is a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear.  There are currently no FDA-approved drug treatments for the nearly 30 million Americans that are affected by debilitating hearing and balance diseases and disorders such as Meniere's disease, sudden sensorineural hearing loss, noise-induced hearing loss, age-related hearing impairment and tinnitus.  Otonomy's core technology is a sustained release formulation developed for optimal delivery of drugs to the middle and inner ear with a single intratympanic (IT) injection.  This technology has broad applicability across a range of therapeutic classes and two products based on this platform are in active development.

Otonomy's lead product candidate, OTO-104, is a sustained release formulation of the steroid dexamethasone.  A Phase 1b clinical trial in Ménière's disease patients has recently been completed, and future studies are being planned in Meniere's disease and other inner ear disorders.  OTO-201, the company's second product candidate, is a novel sustained release antibiotic being developed for the treatment of chronic otitis media.  OTO-201 clinical trials are expected to begin in 2011.  Additional product candidates are expected to target acute and chronic forms of hearing loss, balance disorders, and tinnitus.

For more information visit: www.otonomy.com.

* CIPRODEX is a registered trademark of Bayer AG, licensed to Alcon by Bayer AG.Contact:Vida Communication (On behalf of Otonomy)Stephanie Diaz (investors)

Tim Brons (media)415-675-7400

415-675-7400sdiaz@vidacommunication.com

tbrons@vidacommunication.com
'/>"/>

SOURCE Otonomy, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Otonomy Appoints David A. Weber, Ph.D., Chief Executive Officer
2. Pharmasset Announces the Expansion of the ELECTRON Trial in Chronic Hepatitis C
3. Grifols Announces Combined Operations With Talecris to Begin a New Era as a Global Leader of Life-Saving Plasma Therapeutics
4. Edison Pharmaceuticals Announces FDA Grants EPI-743 Orphan Drug Designation
5. Boston Scientific Announces Favorable Appellate Court Ruling Affirming Invalidity of J&J Patents
6. Alere Inc. Announces Extension of Consent Solicitations Related to its 9.0% Senior Subordinated Notes Due 2016, 8.625% Senior Subordinated Notes Due 2018 and 7.875% Senior Notes Due 2016 and Increased Consent Fees
7. ImaginAb, Inc. Announces Availability of Custom Protein Radiolabeling Services for Molecular Imaging
8. Topaz Pharmaceuticals Announces New Drug Application for the Treatment of Head Lice Accepted by FDA
9. Ore Pharmaceutical Holdings Announces Name Change and Reverse/Forward Stock Split to be Effective June 10, 2011
10. Thoratec Announces Presentations at Upcoming Investor Conferences
11. COPAN Announces Strategic Global Distribution Partnership with Siemens
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... February 23, 2017 Obese people ... caseload for varicose veins in their body. The rising ... prompting the adoption of endovenous laser therapy for treatment ... endovenous laser therapy market, published by Future Market ... choices and consequences of obesity have collectively factored the ...
(Date:2/23/2017)... February 23, 2017 The fast-growing cannabis ... the United States . According to the 2017 Legal ... is expected to create 283,422 jobs by 2020, with an ... the next four years. The accelerating pace of cannabis legalization ... of legal cannabis market, which will further create more business ...
(Date:2/23/2017)... February 23, 2017 The top ... are GE Healthcare, Koninklijke Philips N.V., and Schiller. Collectively, ... the global market in 2015. Strong product portfolio and ... assessed to be aiding these players remain leaders in ... the players in the global market are likely to ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... The International Association of ... “Imagine Me Beyond What You See” body image mannequin art competition. Selected from 15 ... showcased and the winner revealed at the 31st annual iaedp Symposium, March 22 – ...
(Date:2/24/2017)... ... February 24, 2017 , ... Congratulations to Head Over Heels’ ... February 12th. Ms. Esparza qualified into this prestigious status after winning the ... Las Vegas, Nevada. Frida is one of approximately 25 gymnasts in the nation ...
(Date:2/23/2017)... ... February 23, 2017 , ... The 89th Academy Awards ... of the 2016 National Education Policy Center Bunkum Award. We invite you to enjoy ... , This year’s Bunkum winner is the Center for American Progress (CAP), for its ...
(Date:2/23/2017)... ... February 23, 2017 , ... Los Angeles-based weight loss surgeon ... TV’s “Mama June: From Not to Hot,” which will begin airing on February 24, ... known to millions from the 2012 reality television series, “Here Comes Honey Boo Boo.” ...
(Date:2/23/2017)... Los Angeles, California (PRWEB) , ... February 23, ... ... for Global Sports Development will host a diverse symposium on “Doping ... School of Law and Sheppard Mullin Richter & Hampton LLP. The symposium will ...
Breaking Medicine News(10 mins):