Our Products

Our product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States; Kristalose® (lactulose) for Oral Solution, a prescription laxative; Vaprisol® (conivaptan) Injection, for the treatment of hyponatremia; Omeclamox®-Pak for the treatment of H. pylori and duodenal ulcer disease; Vibativ® (telavancin) Injection, for the treatment of certain serious bactierial infections and complicated skin and skin structure infections; and RediTrex® (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.

We have acquired the worlwide rights to ifetroban and are currently developing Boxaban® (ifetroban) Oral Capsule for the treatment of Aspirin-Exacerbated Respiratory Disease; Vasculan® (ifetroban) Oral Capsule for the treatment of systemic sclerosis; and Dyscorban™ (ifetroban) for the treatment of cardiomyopathy in Duchenne Muscular Dystrophy patients.

 

 

Phase: 
Preclinical
Weight: 
0

Acetadote®

MARKETED

Acetadote<sup>®</sup>

Acetadote®

Acetadote® (acetylcysteine) is our IV treatment for acetaminophen overdose, the leading cause of drug toxicity in the U.S. It was developed by Cumberland and was the first injectable product available to treat acetaminophen overdose available in this country. Though safe at recommended doses, acetaminophen can cause liver damage with excessive use.

Acetadote is used in the emergency department, the intensive care unit, and hospital inpatient setting to prevent or lessen liver damage from an overdose of acetaminophen, a common ingredient in many over-the-counter and prescription medications. Acetadote is FDA-approved for adult and pediatric use.  It is free of EDTA as well as any other stabilizing, chelating, or preserving chemicals and has become a standard of care for the treatment of this potentially life-threatening condition.

For more information, including full prescribing and important safety data visit, www.acetadote.com.

 

Visit https://www.acetadote.com/

Caldolor®

MARKETED

Caldolor<sup>®</sup>

Caldolor®

Caldolor® (ibuprofen) was the first injectable therapy approved in the United States for the treatment of both pain and fever. It is indicated in adults and pediatric (patients six months and older) as a sole treatment for the management of mild to moderate pain; as an adjunct to reduce the use of opioids in the management of moderate to severe pain; and for the reduction of fever.

Caldolor provides distinct benefits to physicians treating post-operative pain. In addition to working peripherally at the site of trauma, it also acts centrally to blunt the perception of pain. Clinical trials have shown that Caldolor provides beneficial anti-inflammatory properties while reducing fever, pain, and opioid consumption. Cumberland supplies Caldolor in two presentations – a vial that requires dilution before use and a pre-mixed bag requiring no dilution. The bag presentation is the first and only FDA-approved ready-to-use injectable ibuprofen.

For more information, including full prescribing and important safety data visit, www.caldolor.com.

 

Visit http://www.caldolor.com

Kristalose®

MARKETED

Kristalose<sup>®</sup>

Kristalose®

Kristalose® (lactulose) is the only branded prescription laxative product that combines the established safety and efficacy of lactulose with the convenience and portability of a pre-measured dose. A unique, dry powder crystalline formulation of lactulose, Kristalose is designed to enhance patient compliance in the treatment of acute and chronic constipation. Kristalose dissolves quickly in 4 oz. of water, offering patients a virtually taste-free, grit-free and essentially calorie-free alternative to lactulose syrups.

Kristalose provides a prescription alternative for many patients unable to find relief with over-the-counter laxatives. Additionally, there are no age limitations or length of use restrictions for Kristalose.

For more information, including full prescribing and important safety data visit, www.kristalose.com.

 

Visit http://www.kristalose.com

Omeclamox®-Pak

MARKETED

Omeclamox<sup>®</sup>-Pak

Omeclamox®-Pak

Omeclamox®-Pak is a branded prescription product used for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease.  It combines three well-known and widely prescribed medications packaged together for patient convenience: omeprazole, clarithromycin, and amoxicillin. 

It is the first FDA-approved triple therapy combination medication to contain omeprazole as the proton pump inhibitor, which works to decrease the amount of acid the stomach produces.  Clarithromycin and amoxicillin are both antibiotic agents which hinder the growth of the H. pylori bacteria, allowing the ulcer to heal.  With a simple-to-follow 10-day course of therapy, Omeclamox-Pak has been shown to eradicate H. pylori in up to 90% of patients.

For more information, including full prescribing and important safety data visit, www.omeclamox.com.

 

Visit http://www.omeclamox.com

Vaprisol®

MARKETED

Vaprisol<sup>®</sup>

Vaprisol®

Vaprisol® (conivaptan) is the first and only intravenously administered vasopressin receptor antagonist, a class of pharmaceuticals developed for the treatment of euvolemic and hypervolemic hyponatremia.  Vaprisol is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia by reducing excess water in the body and regulating the water/sodium balance. 

Hyponatremia, an imbalance of serum sodium to body water, is the most common electrolyte disorder among hospitalized patients. It can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure, cancer, and pneumonia.  When partnered with fluid restriction, Vaprisol can provide a positive response in water/sodium balance within 24 hours after beginning therapy.

For more information, including full prescribing and important safety data visit, www.vaprisol.com.

 

Visit http://www.vaprisol.com/

RediTrex®

MARKETED

RediTrex<sup>®</sup>

RediTrex®

RediTrex® (methotrexate) is a line of injectable products designed for patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis. It is designed for patients who have difficulty tolerating or responding to orally delivered methotrexate. It is also approved for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

RediTrex is positioned between the difficult-to-use vial and accompanying syringe treatment option and the expensive auto-injector products. RediTrex prefilled syringes are supplied in eight different dosages assuring accurate dosing safe administration with an automatic retracting needle that reduces the risk of subsequent needle sticks. Each syringe is designed for ease of handling and has a large grip and concave plunger that allows patients with limited dexterity to self-administer the product at a controlled speed. Furthermore, the distinct appearance of RediTrex limits the possible confusion with biologic pens.

For more information, including full prescribing and important safety data visit, www.reditrex.com.

 

Visit https://www.reditrex.com

Vibativ®

MARKETED

Vibativ<sup>®</sup>

Vibativ®

Vibativ® (telavancin) is an FDA-approved injectable antibiotic used in the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.  This lifesaving antibiotic features a dual mode of action designed to treat difficult Gram-positive bacterial infections, including MRSA and those that are classified as multidrug-resistant.  Additionally, clinical data has demonstrated the superior ability of Vibativ to penetrate lung tissue – an important benefit when treating secondary bacterial infections, such as those seen in COVID-19 patients.

For more information, including full prescribing and important safety data visit, www.vibativ.com.

 

Visit https://www.vibativ.com/

Boxaban®

PHASE 2

Boxaban<sup>®</sup>

Boxaban®

Boxaban® (ifetroban) oral capsule is being developed by Cumberland for the treatment of a severe form of asthma known as aspirin-exacerbated respiratory disease (AERD).  We received clearance for our Investigational New Drug (IND) Application from the FDA to commence studies for Boxaban® in patients with AERD. We have completed an initial Phase II clinical trial and a follow-on Phase II clinical study is underway.

Aspirin-exacerbated respiratory disease, also known as Samter's Triad, involves chronic asthma and nasal polyposis that is worsened by aspirin or nonsteroidal anti-inflammatory drugs. Current treatment of AERD remains a challenge, as novel and effective treatment modalities are lacking for this unmet medical need. Approximately one in 20 asthmatic adults (nearly 1 million patients in the United States) suffer from AERD and the disease awareness is growing within the medical community.

 


Vasculan®

PHASE 2

Vasculan<sup>®</sup>

Vasculan®

Vasculan® (ifetroban) oral capsule is being developed by Cumberland for the treatment of systemic sclerosis (SSc), also known as scleroderma. It is a rare autoimmune disorder that results in a thickening of the skin and internal organs. With pulmonary disease emerging as the major cause of death in SSc patients, preclinical studies have found that ifetroban can prevent cardiac and lung fibrosis. Following FDA clearance of our IND, we have initiated a Phase II study in SSc patients.

SSc affects 2.5 million people worldwide and does not yet have a proven curative therapy. Although several medications that suppress the immune system are used to slow progression of the disease, there is no universally effective treatment to improve the function of affected internal organs. Hence the treatment of SSc remains an unmet medical need.

 


Dyscorban®

PHASE 2

Dyscorban<sup>®</sup>

DyscorbanTM (ifetroban) oral capsule is being developed by Cumberland for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy (DMD).  Preclinical studies demonstrated that ifetroban improved cardiac function, reduced cardiac fibrosis and increased survival in multiple animal models. These encouraging findings compelled us to develop a clinical program to evaluate ifetroban for the treatment of DMD cardiomyopathy.  The FDA has cleared the IND for this program, and a Phase II clinical trial in DMD patients has been initiated.

DMD is a rare, fatal, genetic neuromuscular disease and is characterized by the progressive loss of muscle which results in deterioration of the skeletal, heart, and lung muscles. This deterioration leads to decreased mobility resulting in wheelchair dependency. DMD affects 1 in 3,500-5,000 male children, making it the most common childhood muscle disease. Cardiomyopathy is the leading cause of death in these DMD patients – and with no effective treatment, this condition remains an unmet medical need.