Trius Therapeutics to Conform Protocol for Upcoming Torezolid Phosphate Phase 3 Trial With Newly Released FDA Draft Guidance
Published: Mar 01, 2010
SAN DIEGO, March 1 /PRNewswire/ -- Trius Therapeutics, Inc. announced that on February 26th, 2010, the FDA issued new draft guidance on non-inferiority clinical trials that will apply to the design of the Company's proposed Phase 3 trials for its investigational antibacterial drug torezolid phosphate. Trius is conforming the protocol for its first Phase 3 clinical trial with the new draft guidance and plans to submit the revised protocol to the FDA as soon as possible. The Company believes that the draft guidance will provide greater clarity to the process of finalizing the design of its Phase 3 trials. As a result of the new guidance, the Company has temporarily delayed its IPO until it can modify the protocol for its Phase 3 trial.
About Trius Therapeutics
Trius Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious, life-threatening infections.
CONTACT: Jason Spark of Porter Novelli Life Sciences, +1-619-849-6005,
firstname.lastname@example.org, for Trius Therapeutics, Inc.
Web site: http://www.triusrx.com/