Date: 2014-06-05
Type of
information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in the New England Journal of Medicine
Company: The Medicines Company (USA - NJ)
Product: Orbactiv™ (oritavancin)
Action
mechanism:
- antibiotic. Oritavancin is a semisynthetic lipoglycopeptide analogue of vancomycin that contains the heptapeptide core common to all glycopeptides. Oritavancin’s mechanism of action involves at least 3 known mechanisms: inhibition of transglycosylation, inhibition of transpeptidation, and cell membrane interaction/disruption. This antibiotic has been developed by Targanta Therapeutics. This company has been bought out by The Medicines Company in January 2009. In December 2008, the FDA issued a complete response letter to Targanta\'s New Drug Application (NDA) indicating that it could not approve the NDA in its present form and that it would be necessary for Targanta to perform an additional adequate and well-controlled study to demonstrate the safety and efficacy of oritavancin in patients with cSSSI before the application may be approved.
Disease: acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On June 5, 2014, The Medicines Company announced the publication of the results from the SOLO I Phase 3 clinical trial of Orbactiv™ (oritavancin), an investigational intravenous antibiotic treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), in the New England Journal of Medicine. The publication reported that a single 1200 mg intravenous dose of Orbactiv™ was non-inferior to twice-daily intravenous dosing of vancomycin given for 7 to 10 days in patients with ABSSSI caused or suspected to be caused by Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).
- Orbactiv™ (oritavancin) was evaluated in two large randomized, well-controlled Phase 3 clinical trials (SOLO I and SOLO II). The combined SOLO studies represent the largest patient population (1,987 patients in intent-to -treat population) that evaluated an anti-infective for the treatment of ABSSSI in controlled clinical trials, and have assessed one of the largest subsets of patients with documented MRSA infection (405 patients). Orbactiv™ was administered intravenously as a 1200 mg single dose in these studies. In February 2014, the FDA accepted the filing of a new drug application (NDA) for Orbactiv™ with priority review. The Medicines Company is seeking approval of Orbactiv™ for the treatment of ABSSSI caused or suspected to be caused by susceptible Gram-positive bacteria, including MRSA, administered as a single dose. The FDA action date (PDUFA date) for Orbactiv™ is August 6, 2014.
Is
general: Yes
