Date: 2014-06-06
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in the Lancet Infectious Diseases
Company: Cubist Pharmaceuticals (USA -MA)
Product: Sivextro™ (tedizolid phosphate)
Action
mechanism: Sivextro™is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
Disease: acute bacterial skin and skin structure infections (ABSSSI) complicated skin and soft tissue infections (cSSTI)
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On June 6, 2014, Cubist Pharmaceuticals announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic Sivextro™ (tedizolid phosphate), which is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI).The authors note that ESTABLISH-2 was the first prospectively designed clinical trial consistent with the fundamental elements outlined in the final FDA ABSSSI Guidance released in 2013. The published data are based on one of the two global Phase 3 clinical studies of Sivextro™ (ESTABLISH-1 and ESTABLISH-2), which met the primary and secondary endpoints defined by the FDA and European Medicines Agency (EMA). The clinical trials enrolled 1,333 people in the U.S., Europe and other regions worldwide. As outlined in The Lancet Infectious Diseases, a focus of the ESTABLISH-2 clinical trial was to evaluate the efficacy and safety of the I.V. to oral transition of Sivextro™ in the treatment of ABSSSI. The randomized, controlled Phase 3 clinical trial compared Sivextro™ 200 mg given as a once daily dose for six days with linezolid 1200 mg divided as a twice daily dose for 10 days, both administered by I.V. with a possible switch to oral study treatment, when pre-specified criteria were met. Results showed a six-day course of once-daily Sivextro™ to be non-inferior to 10 days of twice-daily linezolid for the treatment of ABSSSI. In the ESTABLISH-2 study, the adverse event rates were similar for both Sivextro™ and linezolid treated patients. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups. Data from the ESTABLISH-2 study, along with data from the previously published ESTABLISH-1 study, served as the basis for Cubist’s New Drug Application (NDA) for Sivextro™, for which Cubist is seeking approval in acute bacterial skin and skin structure infections (ABSSSI). The FDA accepted the NDA in December 2013 for Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2014. On March 31, 2014 the FDA Anti-Infective Drug Advisory Committee (AIDAC) voted unanimously to recommend approval of Sivextro™. The Company also recently announced that the EMA accepted for review its Marketing Authorization Application (MAA) for Sivextro™, for which Cubist is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI).
