Medicines Company Publishes Phase III Results On Orbactiv For Skin Infections
By Cyndi Root
The Medicines Company announced in a press release that it has published results from a Phase III trial on Orbactiv (oritavancin) in the New England Journal of Medicine (NEJM). Orbactiv is an investigational antibiotic in the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Results from the SOLO I Phase III clinical trial showed 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.
G. Ralph Corey, lead author of the publication, Professor of Medicine and Infectious Disease at Duke University and Principal Investigator of the SOLO Trials, said, “A publication in the New England Journal of Medicine reflects the quality of work of the SOLO investigators and the importance of new treatments for ABSSSI.”
Orbactiv
In February 2014, the Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for oritavancin. The FDA gave it QIDP status (Qualified Infectious Disease Product) and a Priority Review. The FDA’s decision on the NDA is due by August 6, 2014. Upon approval, The Medicines Company will have several years of marketing exclusivity.
Orbactiv (oritavancin) works in at least three known ways. It inhibits transglycosylation, inhibits transpeptidation, and interacts with or disrupts the cell membrane. These mechanisms allow Orbactiv to act against vancomycin-resistant organisms and kill Gram-positive bacteria. The agent is manufactured in a semi-synthetic preparation and the company is seeking approval for a 1200 mg dose.
Orbactiv SOLO Trials
In the study entitled, “Single-Dose Oritavancin in the Treatment of Acute Bacterial Skin Infections,” published in the NEJM, investigators conducted a trial in which 475 adults with ABBSSI received a single intravenous dose of 1200 mg of oritavancin and 479 people received a regimen of intravenous vancomycin twice daily for 7 to 10 days. The trial included three primary endpoints testing for noninferiority to vancomycin: cessation of spreading or reduction in lesion size, absence of fever, and no need for administration of a rescue antibiotic 48 to 72 hours after administration of oritavancin. All primary endpoints were met, signifying a noninferiority margin of 10 percentage points for oritavancin versus vancomycin. Adverse events were similar.