Navigation Links
Otonomy Doses First Subjects in Phase 3 Clinical Trials of OTO-201 in Pediatric Patients Undergoing Ear Tube Placement Surgery
Date:12/11/2013

SAN DIEGO, Dec. 11, 2013 /PRNewswire/ -- Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced dosing of the first patients in its two Phase 3 trials of OTO-201 for the treatment of pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. OTO-201 is Otonomy's proprietary, sustained-exposure otic formulation of the antibiotic ciprofloxacin.

(Logo: http://photos.prnewswire.com/prnh/20130806/MM59802LOGO)

The two identical, prospective, randomized, double-blind, sham-controlled Phase 3 studies are expected to enroll a combined total of approximately 500 subjects, ages 6 months to 12 years old, across 60 trial sites in the United States and Canada. The primary endpoint of the studies is the effectiveness of OTO-201 as measured through day 15 by the cumulative proportion of study treatment failures, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication. Completion of patient enrollment is expected during the second quarter of 2014.

"Following tube placement surgery, we frequently see parents of these very young patients struggle to comply with repeat administration of ear drops which is important to prevent post-operative complications," said pediatric otolaryngologist, Eric A. Mair, M.D., of Charlotte Eye, Ear, Nose & Throat Associates. "The potential to administer a full course of antibiotics with a single dose given during the procedure would be an attractive treatment option for patients, parents and physicians."

Added David A. Weber, Ph.D., president and CEO of Otonomy, "Initiating the two registration studies for O
'/>"/>

SOURCE Otonomy, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Otonomy Enrolls First Patient in Pivotal Phase 2b Study of OTO-104 in Menieres Disease
2. Otonomy Acquires Assets and Patent Rights for Tinnitus Program
3. Otonomy Completes $45.9 Million Series C Equity Financing
4. S1 Biopharma Doses First Patients in Phase 2a Clinical Trial of Lorexys in Premenopausal Women with HSDD
5. CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A
6. Summit Yields One-of-a-Kind Opportunity To Reduce Prescription Drug Overdoses
7. CLAAD Warns of Increase in Prescription Drug Overdoses
8. AcelRx Pharmaceuticals Doses the First Patients in ARX-04 Phase 2 Clinical Study
9. As Prescription Painkiller Overdoses Mount, Researchers Outline Effective Approaches to Curb Epidemic
10. First Interim Analysis Of NW Bios Phase III GBM Trial Triggered By Reaching Required Number Of "Events"
11. Varian Medical Systems Schedules First Quarter FY2014 News Release and Conference Call
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... According to the new market research report ... Material (Metal, Glass, Plastic), by Application [GC, LC (HPLC, ... by MarketsandMarkets, the Chiral Chromatography Columns Market was valued ... at a CAGR of 5.2% from 2013 to reach ... market data tables and 15 figures spread through 135 ...
(Date:9/2/2014)... September 2, 2014 , Registry ... quality of life and treatment satisfaction [ 1 ... ]        (Photo: ... 02 September 2014, Barcelona, Spain : ... PREvention oF thromboembolic events-European Registry in Atrial Fibrillation (PREFER ...
(Date:9/2/2014)... RALEIGH, N.C. and ,S-HERTOGENBOSCH, the ... Europe ( http://www.healthlinkeurope.com ) has expanded its North American ... 100% medical facility, providing warehousing, fulfillment and order to ... North America , utilizing our global ERP platform. ... since 1994 serving our customers in Europe ...
Breaking Medicine Technology:Chiral Chromatography Column Market Worth $87.8 Million by 2018 2Chiral Chromatography Column Market Worth $87.8 Million by 2018 3Chiral Chromatography Column Market Worth $87.8 Million by 2018 4One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 2One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 3One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 4One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 5One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 6One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 7One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines 8HealthLink Europe opens North American medical warehouse operation 2
(Date:9/2/2014)... York (PRWEB) September 02, 2014 - ... defined as a class of diagnostic test that analyzes ... The nucleic acids and proteins that belong to individual ... therapy, health condition, or risk of developing a specific ... better known as (MDx) evaluating the new class of ...
(Date:9/2/2014)... 02, 2014 Welcome to Arthritis ... 4.6 million Canadians living with the disease, The Arthritis ... Arthritis” video series featuring well-known Canadians from different walks ... ,      Lloyd Robertson , veteran news anchor ... skier ,      Amy Cotton , two-time ...
(Date:9/2/2014)... there might be a new salve to dominate medicine cabinets ... lowly salamander. Salamanders may not be the cuddliest of animals, ... of seriously damaged body parts. Now, a new report published ... Journal , identifies a small protein (called a "peptide") ... to unlocking the secret of this amazing wound healing trick ...
(Date:9/2/2014)... Two Kansas State University biochemists have discovered a family ... Staphylococcus aureus , a pathogenic bacterium that can ... , Brian Geisbrecht, professor of biochemistry and molecular biophysics, ... S. aureus , which is the cause of increasing ... journal Proceedings of the National Academy of Sciences ...
(Date:9/2/2014)... New York (PRWEB) September 02, 2014 ... the bony block or the vertebrae in our spine ... are the most common fractures in people with osteoporosis ... major reason behind such fractures, forms of metastatic tumors ... fall or a sports injury can also lead to ...
Breaking Medicine News(10 mins):Health News:Molecular Diagnostic Market: Global Factors and Perspectives by Transparency Market Research 2Health News:Molecular Diagnostic Market: Global Factors and Perspectives by Transparency Market Research 3Health News:Molecular Diagnostic Market: Global Factors and Perspectives by Transparency Market Research 4Health News:‘Voices of Arthritis’ Launches Awareness Month 2Health News:‘Voices of Arthritis’ Launches Awareness Month 3Health News:Salamander skin peptide promotes quick and effective wound healing in mice 2Health News:Biochemists find new treatment options for staph infections, inflammatory diseases 2Health News:An Overview of the Minimally Invasive Vertebral Compression Fracture Repair Market by Transparency Market Research 2Health News:An Overview of the Minimally Invasive Vertebral Compression Fracture Repair Market by Transparency Market Research 3
... to the diet may help reduce the risk of developing ... more than 95,000 women who never had kidney stones, researchers ... the study. Women who consumed the most calcium had a ... who consumed the least amount. The use of calcium supplements ...
... calcium to the diet may help reduce the risk of ... of more than 95,000 women who never had kidney stones, ... of the study. Women who consumed the most calcium had ... women who consumed the least amount. The use of calcium ...
... that by adding more calcium to the diet may help ... ,In a study of more than 95,000 women who ... over the eight years of the study. Women who consumed ... kidney stones compared to women who consumed the least amount. ...
... in the United States suffer a stroke. About one-third of ... to perform daily functions that consume lots of energy, such ... research shows , stroke survivors should be urged to exercise ... seven times a week, can help reduce the risk of ...
... strategies to improve lifestyle habits may not lower blood ... reading .// ,Researchers investigated whether simple interventions, ... lower sodium intake, and advice for a healthier diet, ... care. Nearly 300 patients without an established history of ...
... dental X-rays during pregnancy are three-times more likely to ... study.// ,Researchers studied about 4,500 women. They found ... have babies weighing less than five pounds. Specialists seem ... pregnant women were exposed to was very low and ...
Cached Medicine News:
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: