Navigation Links
Otonomy Enrolls First Patient in Pivotal Phase 2b Study of OTO-104 in Meniere's Disease
Date:12/11/2013

hair of the department of otolaryngology – head and neck surgery at Medical University of South Carolina, and clinical investigator for the Phase 2b clinical trial, "Unpredictable spontaneous vertigo is life altering and a source of considerable distress for patients with Meniere's disease, and there are currently no FDA-approved drug therapies. This study may bring us closer to providing a safe and effective treatment option for the many patients with this debilitating disorder."

The study will also assess the safety and tolerability of OTO-104, which is a proprietary, sustained-exposure otic formulation of dexamethasone. Upon screening, all subjects will enter into a 4-week observational period for a baseline assessment during which subjects will record their vertigo and tinnitus symptoms via a daily diary. Following the lead-in period, eligible subjects will be randomized 1:1 to a single intratympanic injection of 12 mg OTO-104 or placebo (gel vehicle). Tinnitus will also be assessed as a secondary endpoint in the study.

Additional information about study protocol and enrollment sites for the study can be found at www.clinicaltrials.gov using the study identifier NCT01412177.

About OTO-104
OTO-104 is a sustained-exposure formulation of the steroid dexamethasone that has been designed for intratympanic (IT) injection into the middle ear for the potential treatment of a broad range of inner ear disorders including vertigo and acute onset hearing loss. OTO-104 is based on Otonomy's proprietary formulation technology which is intended to overcome the limitations associated with the use of unapproved short-acting solutions in the ear. These include limited and variable drug exposure, need for repeat IT injections, and potential for suboptimal efficacy. OTO-104 successfully completed a Phase 1b trial in Meniere's disease patients that demonstrated a clinically meaningful reduction in vertigo f
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Otonomy Completes $45.9 Million Series C Equity Financing
2. Otonomy Acquires Assets and Patent Rights for Tinnitus Program
3. CalHIPSO Enrolls Over 7,700 Providers in EHR Implementation Program, Hits Other Key Milestones After First Two Years
4. Boehringer Ingelheim Enrolls First Patients in Pivotal Phase 3 Interferon-Free Hepatitis C Trial Program
5. Adynxx Enrolls First Patient in Phase 2 Proof-of-Concept Study for AYX1, Lead Compound for the Prevention of Post-Surgical Pain
6. ROX Medical enrolls first patients in Ireland for CONTROL-HTN hypertension trial at Beaumont and Mater Private Hospitals
7. ROX Medical enrolls first UK patients in CONTROL-HTN hypertension trial at Eastbourne General Hospital
8. Intarcia Enrolls First Patients in "FREEDOM" Global Phase 3 Program for ITCA 650 in Type 2 Diabetes
9. Barts Hospital, London enrolls first patients in ROX Medicals CONTROL-HTN resistant hypertension trial
10. Epizyme Enrolls First Patient in Phase 1/2 Clinical Trial of EPZ-6438, an Inhibitor of EZH2
11. Cell Therapeutics, Inc. (CTI) to Report First Quarter Financial Results on April 20
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... HILL, N.C. , May 22, 2015 /PRNewswire/ ... critical to pharmaceutical brand recognition and success. ... LLC conducted a study to provide pharmaceutical and ... of investment (FTEs and budget) that are being ... Pharmaceutical and biotech marketing managers can utilize this ...
(Date:5/22/2015)... , May 22, 2015 Electrophysiologist Kevin ... recently traveled to Boston, MA ... the 2015 Heart Rhythm Society conference. These scientific ... focus on the ideas, people and technology that ... is a hybrid, minimally invasive cardiac operation that ...
(Date:5/22/2015)... 22, 2015  RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX), a ... and regeneration, today announced that J.J. Finkelstein , ... a corporate overview at two upcoming investor conferences. ... 4 th Annual Microcap Conference on Thursday May ... at 11:00 am EDT.  A webcast will be ...
Breaking Medicine Technology:Effective Marketing Services Group Critical for Pharmaceutical Brand Recognition 2St. Joseph's Hospital Heart Institute Physician Presents at Heart Rhythm Society 2St. Joseph's Hospital Heart Institute Physician Presents at Heart Rhythm Society 3RegeneRx to Present at 2 Investor Conferences 2RegeneRx to Present at 2 Investor Conferences 3
... Feb. 1, 2011 Reportlinker.com announces that a new ... Personalized Medicine - scientific & commercial ... Summary The aim of ... right drug to the right patient and, in some ...
... of Dermatology, Laser and Cosmetics is now offering Alma Lasers ... Boerne area to treat superficial vascular and pigmented irregularities and ... add this new service for our patients," said Dr. Ghohestani, ... a long time provider of aesthetic medicine, we wanted to ...
Cached Medicine Technology:Reportlinker Adds Personalized Medicine - Scientific & Commercial Aspects 2Reportlinker Adds Personalized Medicine - Scientific & Commercial Aspects 3San Antonio's Texas Institute of Dermatology, Laser and Cosmetics Adds Alma Lasers Harmony XL Cosmetic Laser to Offer Advanced Rejuvenation Treatments to Patients 2
(Date:5/24/2015)... Scottsdale, Arizona (PRWEB) May 24, 2015 ... hired former Millennial Media strategy executive Jay Krihak ... as Medicx looks to ramp up its expertise ... services of the Pharmaceutical and Health sectors. , ... ad tech executive. Most recently, Krihak led sales ...
(Date:5/23/2015)... (PRWEB) May 23, 2015 On May ... powers of a youngster's yogic power learned through meditation ... Nithyananda Swami in Bangalore, India. , Yogamaatha, a nine-year-old ... than 50 high profile professionals attending the 2015 Business ... reading fluently -- blindfolded. , In a demonstration ...
(Date:5/23/2015)... On May 16, the team at Farrell’s ... 5k mud obstacle run that raised funds for multiple sclerosis. ... and the reason we participated was to support people living ... Farrell’s eXtreme Bodyshaping. “One-hundred percent of the funds raised go ... was not only attended by eXtreme Bodyshaping staff, but members ...
(Date:5/23/2015)... Viejo, CA (PRWEB) May 23, 2015 Add ... from Pixel Film Studios. , It's as simple as ... as utilizing the included tool for full effect. , ... filmed on high-dynamic range 5k sensors making this the ultimate ... The prismatic flares included in this package are movie files ...
(Date:5/22/2015)... The American College of Traditional Chinese ... They will hold a webinar on the updates of ... on Classical Chinese Medicine. , Webinar – First Professional ... the Dean of Clinical Education, will lead this webinar ... Doctorate program. ACTCM is currently developing this degree program ...
Breaking Medicine News(10 mins):Health News:Medicx Media Solutions Expands Executive Team 2Health News:Nine-Year-Old Reads Blindfolded at Business Advocacy Summit 2Health News:Nine-Year-Old Reads Blindfolded at Business Advocacy Summit 3Health News:Farrell’s eXtreme Bodyshaping Team Runs through the Muck for MS 2Health News:Developers at Pixel Film Studios Release ProFlare 5K Prism for Final Cut Pro X. 2Health News:ACTCM Announces Upcoming June Events 2
... 17 (HealthDay News) -- Some doctors post unethical and ... need for more oversight of physicians, use of social ... "tweets" sent by 260 U.S. physicians, each with 500 ... percent were unprofessional. This means the tweets ...
... By Steven Reinberg HealthDay Reporter , THURSDAY, Feb. ... 14 in the United States are drinking beer, liquor and ... the surprise is that many of these underage drinkers aren,t ... them or smuggling alcohol out of the family liquor cabinet. ...
... exposure from cell phone use does not appear to ... significant amount, a study by University of Manchester scientists ... the UK Office of National Statistics to look at ... England between 1998 and 2007. The study, published ...
... Reinberg HealthDay Reporter , WEDNESDAY, Feb. 16 (HealthDay ... you take a sugar pill but believe it is medicine, ... the opposite may also be true. In the study, ... either were or were not receiving a powerful painkiller, remifentanil ...
... total knee replacement (TKR) are age 60 to 80. ... reduction in knee pain and a significant improvement in the ... raised about the decline in physical function over the long ... revealed today at the 2011 Annual Meeting of the American ...
... for New Jersey,s 12th Congressional District, has been chosen ... in honor of his work as an advocate for ... to expand America,s scientific workforce., Specifically, the award selection ... Science (AAAS) said that Rep. Holt "was selected on ...
Cached Medicine News:Health News:Some Docs May Use Twitter for 'Unprofessional' Messages: Report 2Health News:Many Kids Who Drink Get Liquor From Home: Report 2Health News:Many Kids Who Drink Get Liquor From Home: Report 3Health News:Cell-phone use not related to increased brain cancer risk 2Health News: Placebo Effect May Work in Reverse 2Health News: Placebo Effect May Work in Reverse 3Health News:Total knee replacement patients functioning well after 20 years 2Health News:2010 AAAS Philip Hauge Abelson Award presented to the Honorable Rush Holt, Ph.D., for supporting science in Congress 2Health News:2010 AAAS Philip Hauge Abelson Award presented to the Honorable Rush Holt, Ph.D., for supporting science in Congress 3Health News:2010 AAAS Philip Hauge Abelson Award presented to the Honorable Rush Holt, Ph.D., for supporting science in Congress 4
SunGlide™ Stylette - Blue Neonatal. Use in 2.0 to 3.5mm tubes. 25/box....
Hollow Copper Tube with Suction Port 16.5....
Surgical Stainless Steel Adult 16.5....
FlexiSlip™ Plastic coated malleable metal core. Single use, Sterile, Latex Free. Soft distal tip flexes to reduce risk of trauma to patient. Malleable metal core is easy to shape. Low friction ...
Medicine Products: