Cubist announced that it has submitted a New Drug Application (NDA) to the FDA for its investigational antibiotic tedizolid phosphate (TR-701) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The NDA submission was based on data from two Phase 3 late-stage clinical studies, ESTABLISH 1 and ESTABLISH 2, which enrolled 1,333 people in the U.S., Europe and other regions worldwide. In the two Phase 3 studies in ABSSSI, results demonstrated that tedizolid 200mg once daily for six days was statistically non-inferior to 10 days of linezolid 600mg twice daily for the primary efficacy endpoints. The primary endpoints for both studies were met.
Tedizolid phosphate is a once daily oxazolidinone being developed for both intravenous and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
Earlier this year, tedizolid phosphate was granted Fast Track status by the FDA for its Qualified Infectious Disease Product (QIDP) indications of ABSSSI, as well as hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
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