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In addition to the detailed efficacy and safety results of the ESTABLISH-2 study, which build upon the top-line
results previously announced, Trius presented the results of a drug interaction clinical study demonstrating that tedizolid phosphate does not increase blood pressure when used in conjunction with vasoconstrictor drugs such as decongestants. In addition, the results of a separate clinical cardiovascular safety study showed that tedizolid is not associated with heart beat abnormalities at up to six times its effective dose, the maximum dose examined in the study. The results of both studies further support the safety profile for tedizolid. In addition, in an oral presentation, Trius provided an overview of data on an emerging class of bacterial pathogens that is resistant to linezolid (Zyvox), the only marketed drug of the same class as tedizolid. To date, these strains have proven susceptible to tedizolid.
"There has been a significant need for new antibiotic therapies targeting resistant bacterial infections, such as MRSA," said Jeffrey Stein, Ph.D., CEO and President of Trius Therapeutics. "We are very excited to share these results, which build upon and are consistent with those from our first Phase 3 study. These combined results show that tedizolid phosphate represents a potential new therapy to treat severe skin infections with a once daily intravenous infusion or pill in fewer days than existing antibiotic medications. Combined with the results of our multiple other clinical and nonclinical studies, we believe that tedizolid may offer substantial benefits to patients and, potentially, payers and the healthcare system."