Date: 2014-10-09
Type of
information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in the journal Clinical Infectious Diseases
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. Its 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.
Disease: acute bacterial skin and skin structure infections (ABSSSI)
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On October 9, 2014, The Medicines Company announced the publication of the results from the SOLO II Phase 3 clinical trial of Orbactiv™ (oritavancin) for injection in the journal Clinical Infectious Diseases. Orbactiv™, is the first and only single dose intravenous antibiotic approved by FDA for the treatment of adults with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused or suspected to be caused by susceptible isolates of designated Gram-positive pathogens. The publication reported that a single, once only, 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).
- A single 1200 mg IV dose of Orbactiv™ results in efficacy in ABSSSIs that is comparable and statistically non-inferior to vancomycin administered intravenously for 7-10 days. Orbactiv™ had a safety profile comparable to vancomycin when monitored for up to 60 days following a single dose, with similar intensity, onset and duration of AEs.
- 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.
Is
general: Yes
