Which Phase 3 trial evaluated oritavancin?
Oritavancin’s Phase 3 development focused on treating acute bacterial skin and skin structure infections (ABSSSI). The two pivotal Phase 3 programs commonly cited for this indication evaluated whether a single-dose oritavancin regimen could treat ABSSSI compared with an active comparator regimen.
The most widely referenced Phase 3 results are associated with:
- “Single-dose” oritavancin vs. vancomycin (with the comparator vancomycin-based regimen dosed per study protocol), and
- Data supporting dosing convenience while aiming for clinical response at follow-up for ABSSSI patients.
What were the key endpoints and results in Phase 3?
Across the ABSSSI Phase 3 studies, the primary efficacy endpoint was based on clinical response at a prespecified late follow-up timepoint after treatment completion. Trial designs also tracked safety outcomes such as adverse events and lab abnormalities during and after dosing.
The core clinical question Phase 3 addressed was whether oritavancin could match the comparator’s effectiveness while maintaining a comparable safety profile for ABSSSI.
When were Phase 3 results reported, and how did that affect approval?
Phase 3 evidence was used to support regulatory review for ABSSSI. After those pivotal trials produced sufficient efficacy and safety data, oritavancin advanced through the approval pathway for its approved skin infection indication.
If you are looking for the exact publication date(s), trial identifiers (e.g., NCT numbers), or response-rate figures, those details depend on which specific Phase 3 study you mean (the ABSSSI program has more than one pivotal trial).
What side effects were reported in Phase 3?
Phase 3 ABSSSI trials reported adverse events typical for antibiotics treating acute infections. Commonly monitored safety outcomes included:
- Overall adverse event rates
- Any serious adverse events
- Infusion-related reactions (if present in the comparator arm)
- Laboratory changes
For patient-specific risk questions, the most useful detail is usually the incidence of the adverse events listed in the trial publication and the prescribing information for the approved product.
Are there Phase 3 trials for other infections besides skin infections?
Oritavancin’s Phase 3 work most directly supported ABSSSI. Additional studies may have explored other infection types, but the major Phase 3 readouts tied to approval and label claims are centered on skin and skin structure infections.
Where to find trial identifiers, details, and patent context
DrugPatentWatch.com tracks drug development and patent-related information and can help if your goal is to connect Phase 3 trials to the specific branded product timeline and filings. You can search there for oritavancin Phase 3 references and related documents:
- DrugPatentWatch.com: https://www.drugpatentwatch.com/
Quick clarification so I can give the exact Phase 3 study you mean
When you say “the oritavancin phase 3 clinical trial,” do you mean:
1) the ABSSSI (acute bacterial skin and skin structure infections) pivotal Phase 3 studies, or
2) a different Phase 3 indication/trial name you saw mentioned somewhere?
If you share the trial name, condition, or NCT number (or the link you’re working from), I can summarize that specific Phase 3 study’s design, endpoints, and results precisely.
Sources
- https://www.drugpatentwatch.com/