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:6/23/2016)... , June 23, 2016 ... "Surgical Procedure Volumes: Global Analysis (United States, China, ... Canada)" report to their offering. ... essential tool for healthcare business planners, provides surgical procedure ... at surgery trends with an in-depth analysis of growth ...
(Date:6/23/2016)... , June 23, 2016 ... but it continues to present great opportunities to investors. ... for today: Intrexon Corp. (NYSE: XON ), ... Pharmaceuticals Inc. (NASDAQ: ARNA ), and Regeneron ... about these stocks and receive your complimentary trade alerts ...
(Date:6/23/2016)... DIEGO , June 23, 2016 ... programs that address medical conditions resulting from a ... it has appointed Greg Doyle as ... of Leading BioSciences, executive management team and board ... and chief financial officer. He will provide continued ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... ... 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join ... wage raise to $12 an hour by 2020 and then adjusting it yearly to increase ... of the minimum wage, assure the wage floor does not erode again, and make future ...
(Date:6/24/2016)... Nevada (PRWEB) , ... June 24, 2016 , ... ... Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing operations ... in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a ...
Breaking Medicine News(10 mins):