~ Buy the ORBACTIV (oritavancin diphosphate) Drug Profile, 2024 PDF Report in the Report Store ~

CLINICAL TRIALS PROFILE FOR ORBACTIV

505(b)(2) Clinical Trials for orbactiv

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02471690 ↗	Study to Evaluate the Safety,Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers	Completed	The Medicines Company	Phase 1	2015-07-01	The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin
New Formulation	NCT03873987 ↗	Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients	Completed	Melinta Therapeutics, Inc.	Phase 1	2019-07-16	This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin

All Clinical Trials for orbactiv

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02340988 ↗	Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects	Completed	The Medicines Company	Phase 1	2015-04-01	The purpose of this study is to assess the drug interaction potential and time course of the effect of oritavancin on warfarin pharmacokinetics in an open label, single arm manner.
NCT02452918 ↗	A Study to Evaluate the Safety of a Single IV Dose of Orbactiv (Oritavancin) in Subjects on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)	Completed	The Medicines Company	Phase 4	2015-06-01	This is a Phase 4, multicenter, open-label safety study of a single 1200 mg intravenous (IV) infusion of oritavancin in adult subjects on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. An additional group of patients with ABSSSI, who are not on concomitant warfarin therapy, will also be enrolled to obtain information regarding the potential for antibody production following a single dose of oritavancin administration in patients.
NCT02470702 ↗	Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects	Completed	The Medicines Company	Phase 1	2015-06-01	This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.
NCT02471690 ↗	Study to Evaluate the Safety,Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers	Completed	The Medicines Company	Phase 1	2015-07-01	The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin
NCT02925416 ↗	Safety of Either a Single or Two IV Doses of Orbactiv in Subjects With ABSSSI	Completed	The Medicines Company	Phase 4	2017-01-01	The purpose of this study is to evaluate the safety and tolerability of two 1200-mg IV infusions of oritavancin when administered one week apart.

Clinical Trial Conditions for orbactiv

Condition Name

Condition Name for orbactiv
Intervention	Trials
Acute Bacterial Skin and Skin Structure Infection	3
Healthy	3
Skin Diseases, Bacterial	1

Condition MeSH

Condition MeSH for orbactiv
Intervention	Trials
Skin Diseases, Bacterial	4
Infections	2
Infection	1
Communicable Diseases	1

Clinical Trial Locations for orbactiv

Trials by Country

Trials by Country for orbactiv
Location	Trials
United States	9

Trials by US State

Trials by US State for orbactiv
Location	Trials
New Jersey	3
Wisconsin	3
Georgia	1
Illinois	1
California	1

Clinical Trial Progress for orbactiv

Clinical Trial Phase

Clinical Trial Phase for orbactiv
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for orbactiv
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	1

Clinical Trial Sponsors for orbactiv

Sponsor Name

Sponsor Name for orbactiv
Sponsor	Trials
The Medicines Company	5
Melinta Therapeutics, Inc.	2

Sponsor Type

Sponsor Type for orbactiv
Sponsor	Trials
Industry	7

Orbactiv Market Analysis and Financial Projection

ORBACTIV (Oritavancin): A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to ORBACTIV

ORBACTIV, also known as oritavancin, is a potent antibiotic approved by the FDA for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)[2].

Clinical Trials Overview

SOLO I and SOLO II Trials

The FDA approval of ORBACTIV was based on the results of the SOLO I and SOLO II clinical trials. These randomized, double-blind, multicenter trials evaluated the efficacy of a single 1,200-mg IV dose of ORBACTIV in 1,987 adults with ABSSSI. The trials demonstrated non-inferiority of ORBACTIV compared to 7-10 days of twice-daily vancomycin for the primary and secondary endpoints, including early clinical response at 48-72 hours and clinical success at day 14-24[2].

Key Findings

• Early Clinical Response: ORBACTIV was effective in achieving early clinical response at 48-72 hours and a ≥20% lesion size reduction during the same period[1].
• Clinical Success: The drug demonstrated clinical success at day 14-24, defined as complete or nearly complete resolution of baseline signs and symptoms[1].
• MRSA Infections: ORBACTIV showed consistent efficacy in patients with confirmed MRSA infections[1].

Safety and Tolerability

The most common side effects identified in the clinical trials included headache, nausea, vomiting, formation of skin and soft tissue abscesses, and diarrhea. The label also includes a warning regarding interference with coagulation tests and interaction with warfarin[2].

Ongoing and Future Clinical Studies

Pediatric Studies

A Phase 2 study is currently recruiting to evaluate the safety and tolerability of single-dose intravenous oritavancin in pediatric subjects (3 months to 17 years) with ABSSSIs. This study compares oritavancin to standard of care antibiotics and involves pharmacokinetic sampling and clinical outcome assessments[4].

New Formulation Studies

A recent study evaluated a new formulation of oritavancin that reduces the intravenous infusion volume from 1000 mL to 250 mL and shortens the infusion time from 3 hours to 1 hour. This new formulation demonstrated a similar safety profile and pharmacokinetics to the original formulation, with no differences in treatment-emergent adverse events[5].

Market Analysis

Market Positioning

ORBACTIV is the first and only antibiotic approved by the FDA for the treatment of ABSSSIs with a single, once-only administration. This unique attribute improves patient compliance and potentially enhances treatment outcomes[2].

Competitive Landscape

ORBACTIV was approved in 2014, the same year as other new antibacterial drugs like dalbavancin (Dalvance) and tedizolid (Sivextro). However, its single-dose regimen sets it apart from competitors, making it a valuable option in the treatment of ABSSSIs[2].

Qualified Infectious Disease Product (QIDP) Designation

As a QIDP, ORBACTIV received priority review and an additional 5 years of marketing exclusivity, which enhances its market position and encourages further development of antibacterial agents[2].

Market Projections

Growing Demand for Antibiotics

The increasing incidence of antibiotic-resistant infections, particularly MRSA, drives the demand for effective and innovative antibacterial agents like ORBACTIV. The global market for antibiotics is expected to grow, with ORBACTIV positioned to capture a significant share due to its unique dosing regimen and efficacy against Gram-positive pathogens[2].

Expanding Indications

Future clinical studies, especially those focusing on pediatric populations and new formulations, could expand the indications for ORBACTIV, further increasing its market potential. The new formulation, with its reduced infusion time and volume, may also enhance patient and healthcare provider preference[5].

Expert Insights

Clarence D. Moore, PharmD, BCSP, assistant professor at Howard University College of Pharmacy, noted: "The approval of Orbactiv adds another medication to the continuous growing arsenal of agents utilized in the treatment of ABSSSI. Orbactiv's unique single, once-only administration ensures that patients receive a complete treatment regimen without the burden of receiving multiple infusions for the management of ABSSSI. This attribute automatically improves patient compliance and potentially improves outcomes."[2]

Key Takeaways

• Clinical Efficacy: ORBACTIV has demonstrated efficacy in treating ABSSSIs, including those caused by MRSA, with a single dose.
• Safety Profile: The drug has a manageable side effect profile, although it requires monitoring for interactions with warfarin and coagulation tests.
• Market Position: ORBACTIV's unique single-dose regimen positions it favorably in the market, with potential for expanded indications.
• Future Studies: Ongoing and future studies, particularly in pediatric populations and new formulations, are expected to further enhance its market potential.

FAQs

What is ORBACTIV used for?

ORBACTIV is used for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible Gram-positive bacteria, including MRSA.

How is ORBACTIV administered?

ORBACTIV is administered as a single 1,200-mg IV dose infused over 3 hours. A new formulation reduces the infusion time to 1 hour and the volume to 250 mL[5].

What are the common side effects of ORBACTIV?

Common side effects include headache, nausea, vomiting, formation of skin and soft tissue abscesses, and diarrhea[2].

Is ORBACTIV effective against MRSA?

Yes, ORBACTIV has demonstrated consistent efficacy in patients with confirmed MRSA infections[1].

What is the QIDP designation for ORBACTIV?

The QIDP designation provides ORBACTIV with priority review and an additional 5 years of marketing exclusivity, encouraging the development of antibacterial agents[2].

Sources

1. Clinical Study Results | Orbactiv® (oritavancin) for injection. Orbactiv.
2. FDA approves oritavancin for skin infections. Managed Healthcare Executive.
3. 206334Orig1s000 - accessdata.fda.gov. FDA.
4. Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin. Mount Sinai.
5. Kimyrsa, An Oritavancin-Containing Product: Clinical Study and Pharmacokinetics. Oxford Academic.