Navigation Links
Trius Therapeutics Obtains Special Protocol Assessment With FDA for Phase 3 Study of Torezolid Phosphate
Date:6/16/2010

SAN DIEGO, June 16 /PRNewswire/ -- Trius Therapeutics, Inc. announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study for the oral dosage form of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI).  The double-blind pivotal study will compare the efficacy and safety of once-daily oral administration of 200 milligrams of torezolid phosphate over six days of treatment to twice-daily oral administration of 600 milligrams of linezolid (Zyvox) for 10 days of treatment. The primary efficacy endpoint will be the cessation of spread of infected lesions and absence of fever at 48 to 72 hours following initiation of treatment. Secondary endpoints will include, among other things, sustained clinical response at the end of therapy visit, and the investigator's assessment of clinical response at all visits and clinical success at the post treatment evaluation visit. Provided non-inferiority is met, an assessment of superiority of torezolid phosphate to linezolid with respect to the primary efficacy endpoint will also be made.

Special Protocol Assessment

The SPA process creates a written agreement between the FDA and a sponsor concerning the clinical trial design, clinical endpoints and other clinical trial issues that can be used to support regulatory approval of a drug candidate. The process is intended to provide assurance that if the agreed upon clinical trial protocols are followed, the clinical trial endpoints are achieved and there is a favorable risk benefit profile, the data may serve as the primary basis of an efficacy claim in support of a New Drug Application (NDA).

About Trius Therapeutics'/>"/>

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

Page: 1 2

Related medicine technology :

1. Trius Initiates U.S. Phase I Trial for its Oxazolidinone Antibacterial Drug, TR-701
2. PacificGMP Completes GMP Product Fill for Trius Therapeutics
3. Trius Doses First Patient in Antibacterial Phase 2 Trial
4. Trius Antibiotics to be Highlighted in 18 Presentations at ICAAC/IDSA
5. Trius Completes Enrollment in Phase 2 Clinical Trial Evaluating Torezolid (TR-701) in Patients With Complicated Skin and Skin Structure Infections
6. Trius Therapeutics Announces Presentations Featuring Torezolid Antibiotic at the 19th European Congress of Clinical Microbiology and Infectious Diseases
7. Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections
8. Trius Torezolid Antibiotic for the Treatment of Severe Skin Infections Featured at ICAAC Meeting
9. Trius Therapeutics Files Registration Statement for Proposed Initial Public Offering
10. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
11. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... ANGELES , Jan. 23, 2015 A lot of ... best methods for treating  certain illnesses, injuries, or conditions. As ... replace previous treatment methods with ones that they consider to ... hernias, there is not one textbook method of treatment that ...
(Date:1/23/2015)... Jan. 23, 2015  Northwest Biotherapeutics, Inc. (NASDAQ: NWBO ... therapies for operable and inoperable solid tumor cancers, announced today ... 7 th Annual Phacilitate Immunotherapy Forum in ... Phacilitate will take place on January 26 at 10:30 a.m. ...
(Date:1/23/2015)... /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) is investigating potential ... ("Advaxis" or the "Company") (NASDAQ: ADXS ), ... to shareholders. On January 21, 2015, an ... Advaxis had misrepresented the clinical data for its ADXS-HPV ...
Breaking Medicine Technology:No One-Size-Fits-All Remedy for Hernia Correction 2NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 2NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 3Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2
... PARIS, June  24, 2011 Sanofi (EURONEXT: SAN and ... four studies  of its once-daily GLP-1 receptor agonist Lyxumia® ... data that demonstrates positive results in type 2 diabetes ...  basal insulin. These data are being presented or published ...
... Global Technologies, Ltd. (GTLL), announced today that it has executed ... Orchard, Inc. GTLL will acquire 100% of ... entity.  All current management, board, and officers will concurrently resign ... are expected to be completed within 21 days. ...
Cached Medicine Technology:Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions 2Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions 3Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions 4Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions 5Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions 6Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions 7Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions 8Global Technologies, Ltd. Announces LOI to Acquire and Merge with Oxygen Orchard, Inc. 2
(Date:1/22/2015)... 23, 2015 AngelWeddingDress, the premier women’s ... maternity wedding dresses. View website of AngelWeddingDress.com ... for maternity wedding dresses online for a bridal party. ... high quality for them. Its maternity wedding dresses are ...
(Date:1/22/2015)... 22, 2015 A new white paper ... and person-centeredness in the long-term care environment as well ... the continuum. The paper, “The Power of Person-Centeredness in ... and practices of the patient, resident and family experience ...
(Date:1/22/2015)... over 20 years, Dr. David Cruz of Cruz Chiropractic Care ... just about every type of injury that can result from car ... twenty-plus years, the team at Doctors on Liens has ... doctor. With the combined breadth of experience between the ...
(Date:1/22/2015)... 22, 2015 A study recently ... flagship journal Medicine & Science in Sports & ... may help reduce gastrointestinal (GI) problems associated with ... Participants in the double-blind, placebo-controlled study took 10 ...
(Date:1/22/2015)... 22, 2015 IsoComforter, Inc. has introduced the ... patented IsoTube design to treat specific body parts and muscle ... progressive and easy to use patented cold therapy machine with ... related orthopedic and muscle injuries. IsoComforter has become the ...
Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2
... guidelines were issued today by the National Institute for Health ... Mental Health,// on the identification, treatment and management of obsessive-compulsive ... adults. , ... all ages, and commonly starts in childhood or adolescence, and ...
... calcium from food tend to gain more bone mass than ... team reports.// ,The team conducted the study to learn ... rapid-growth period of puberty in which 60 percent of the ... , ,The study, published in the November issue of ...
... of breast-feeding is associated with reduction in risk of ... studies have already provided evidence for improved insulin sensitivity ... their counterparts. ,The study is the first of ... lactation and Type 2 diabetes. More than 1,57,003 parous ...
... the life span of people who are suffering from the ... of death from cancer //and is one of the most ... cancer vaccine trial show that it improved the survival rates ... diagnosis to 88 percent." It was also found that the ...
... India has the potential to be the healthcare crisis ... billion from medical tourism, experts say.// ,Speaking at ... Industry (CII) and the Indian Health Care Foundation (IHCF), ... healthcare and facilitate public-private partnership to support quality healthcare ...
... A British grandmother from Wolverhampton has returned to the UK ... lower cost, yet another testimony to India’s burgeoning medical tourism.// ... to have the surgery on the National Health Service (NHS). ... which meant a further six months of chronic pain., ...
Cached Medicine News:Health News:Calcium From Food Better Than From Supplements 2Health News:Breastfeeding To Reduce Risk Of Type 2 Diabetes 2Health News:India Can Manage World’s Healthcare Crisis By 202 2Health News:British Grandmother has timely bypass surgery in India 2
For canalicular laceration involving external 2/3 of one canaliculus. Medical grade silicone. Box of 3, sterile. Note: For safe and proper insertion of the punctum plug above, we recommend the use of...
For Canalicular Stenosis. Non-traumatic tip. Silicone tubing swaged into probe. Note: Tubing securely swaged into malleable stainless steel probes. Medical grade silicone. Box of 3, sterile....
For proper plug sizing....
Contour Design Eyelid Implants....
Medicine Products: