CLINICAL TRIALS PROFILE FOR VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

All Clinical Trials for Vaprisol In 5% Dextrose In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00057356 ↗	Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure	Completed	Cumberland Pharmaceuticals	Phase 2	2002-11-01	This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.
NCT00379847 ↗	An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia	Completed	Cumberland Pharmaceuticals	Phase 3	2004-02-01	This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
NCT00435591 ↗	A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia	Completed	Cumberland Pharmaceuticals	Phase 4	2007-01-01	The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
NCT00478192 ↗	Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia	Completed	Cumberland Pharmaceuticals	Phase 3	2007-04-01	The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
NCT00684164 ↗	Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients	Withdrawn	Astellas Pharma Inc	Phase 3	2008-05-01	Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body. FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.

Clinical Trial Conditions for Vaprisol In 5% Dextrose In Plastic Container

Condition Name

Condition Name for Vaprisol In 5% Dextrose In Plastic Container
Intervention	Trials
Hyponatremia	8
Heart Failure	3
Liver Disease	2
Cerebral Edema	2

Condition MeSH

Condition MeSH for Vaprisol In 5% Dextrose In Plastic Container
Intervention	Trials
Hyponatremia	8
Heart Failure	4
Liver Diseases	2
Edema	2

Clinical Trial Locations for Vaprisol In 5% Dextrose In Plastic Container

Trials by Country

Trials by Country for Vaprisol In 5% Dextrose In Plastic Container
Location	Trials
United States	48
Israel	2
India	2
Colombia	1
South Africa	1

Trials by US State

Trials by US State for Vaprisol In 5% Dextrose In Plastic Container
Location	Trials
New York	4
Florida	4
California	4
South Carolina	4
Ohio	3

Clinical Trial Progress for Vaprisol In 5% Dextrose In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Vaprisol In 5% Dextrose In Plastic Container
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Vaprisol In 5% Dextrose In Plastic Container
Clinical Trial Phase	Trials
Completed	10
Withdrawn	3
Terminated	2

Clinical Trial Sponsors for Vaprisol In 5% Dextrose In Plastic Container

Sponsor Name

Sponsor Name for Vaprisol In 5% Dextrose In Plastic Container
Sponsor	Trials
Cumberland Pharmaceuticals	8
Astellas Pharma Inc	3
University of Washington	1

Sponsor Type

Sponsor Type for Vaprisol In 5% Dextrose In Plastic Container
Sponsor	Trials
Industry	12
Other	9

VAPRISOL in 5% Dextrose: Clinical Trials, Market Analysis, and Projections

Introduction

VAPRISOL, developed by Astellas Pharma, is a groundbreaking drug specifically indicated for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients. This article delves into the clinical trials, market analysis, and future projections for VAPRISOL, particularly focusing on its formulation in 5% dextrose solution.

Clinical Trials Overview

Efficacy in Hyponatremia

Clinical trials have demonstrated the efficacy of VAPRISOL in correcting serum sodium levels in patients with hyponatremia. In studies, patients treated with VAPRISOL showed significant increases in serum sodium concentrations. For instance, 79% of patients treated with 40 mg/day of VAPRISOL achieved an increase of ≥ 4 mEq/L in serum sodium concentration over a 4-day treatment period[2].

Dosing and Administration

VAPRISOL is administered as a 20 mg IV loading dose followed by a continuous infusion of 20 mg/day or 40 mg/day, depending on the patient's response. The drug is available in a premixed formulation in 5% dextrose, which simplifies preparation and administration for healthcare providers[4][5].

Safety Profile

The most common adverse reactions associated with VAPRISOL are infusion site reactions, which occurred in 73% and 63% of subjects treated with 20 mg/day and 40 mg/day, respectively. Despite these reactions, the majority were mild and did not lead to discontinuation of the drug. Serious infusion site reactions, though rare, have been reported[5].

Comparative Studies

Studies comparing different doses of VAPRISOL (20 mg/day vs. 40 mg/day vs. 80 mg/day) showed that the 40 mg/day dose was as effective as higher doses but with fewer adverse events. The 80 mg/day dose was associated with a higher incidence of infusion site reactions and a higher rate of discontinuation for adverse events[2][5].

Market Analysis

Market Need and Demand

Hyponatremia is a prevalent condition in hospitalized patients, affecting approximately 28% of patients upon admission and an additional 14% who develop it during their hospital stay. Severe cases can be life-threatening, making effective treatment crucial. VAPRISOL fills this need by offering a safe and effective treatment option for both euvolemic and hypervolemic hyponatremia[4].

Competitive Landscape

VAPRISOL is the first and only approved drug specifically indicated for the treatment of both euvolemic and hypervolemic hyponatremia. This unique positioning gives it a competitive edge in the market. The premixed formulation in 5% dextrose further enhances its appeal by simplifying the preparation process, making it more convenient for healthcare providers[4].

Market Penetration

Since its approval, VAPRISOL has solidified Astellas' presence in the critical care market. The drug's effectiveness and the convenience of its premixed formulation have contributed to its adoption in hospitals and emergency rooms. Dr. Joseph Verbalis, M.D., noted that "VAPRISOL Premixed in 5% Dextrose will be helpful in quickly preparing treatment for hyponatremia patients," highlighting its practical benefits[4].

Market Projections

Growth Potential

Given the high prevalence of hyponatremia and the lack of other specific treatments, VAPRISOL is poised for significant growth. The drug's unique indication and the convenience of its premixed formulation are expected to drive market demand. As more healthcare providers become aware of its benefits, adoption rates are likely to increase.

Expanding Indications

While VAPRISOL is currently approved for euvolemic and hypervolemic hyponatremia, ongoing and future studies may explore its use in other conditions. For example, a study suggested that a single dose of conivaptan (the active ingredient in VAPRISOL) may reduce intracranial pressure in non-hyponatremic patients with severe traumatic brain injury, potentially expanding its therapeutic scope[3].

Regulatory and Approval Trends

The FDA's approval of the premixed formulation in 5% dextrose in 2008 marked a significant milestone for VAPRISOL. Continued regulatory support and potential approvals for new indications could further bolster its market position.

Key Takeaways

• Efficacy: VAPRISOL has been shown to effectively correct serum sodium levels in patients with euvolemic and hypervolemic hyponatremia.
• Safety: While infusion site reactions are common, they are generally mild and do not often lead to treatment discontinuation.
• Market Need: The high prevalence of hyponatremia in hospitalized patients creates a significant market demand for effective treatments.
• Competitive Edge: VAPRISOL's unique indication and convenient premixed formulation give it a competitive advantage.
• Growth Potential: The drug is expected to see significant growth due to its effectiveness and the convenience of its formulation.

FAQs

What is VAPRISOL used for?

VAPRISOL is used for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients.

How is VAPRISOL administered?

VAPRISOL is administered as a 20 mg IV loading dose followed by a continuous infusion of 20 mg/day or 40 mg/day in a 5% dextrose solution.

What are the common adverse reactions associated with VAPRISOL?

The most common adverse reactions are infusion site reactions, which are generally mild.

Is VAPRISOL available in different formulations?

Yes, VAPRISOL is available in both ampule and premixed formulations in 5% dextrose.

What is the significance of the premixed formulation of VAPRISOL?

The premixed formulation simplifies preparation and administration for healthcare providers, making it more convenient and reducing the risk of errors.

Sources

1. Astellas Pharma US, Inc. - VAPRISOL Launch Press Release.
2. Drugs.com - Vaprisol: Package Insert / Prescribing Information.
3. Scholars.Duke.edu - Open-label randomized trial of the safety and efficacy of a single dose conivaptan.
4. Astellas Pharma US, Inc. - News Room - News Releases - VAPRISOL Premixed in 5% Dextrose.
5. FDA - VAPRISOL Label.