Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Start Date01 Oct 2024

Sponsor / Collaborator

The General Hospital of Shenyang Military Region

CTRI/2024/09/073649 / Not yet recruitingNot Applicable

A Randomized, Multicenter, Open Label, Two Arm, Prospective, Parallel Study to Evaluate the Impact of Addition of Synbiotic Combination to Lactulose in Management of Functional Constipation. - NIL

Start Date30 Sep 2024

Sponsor / Collaborator

Dr. Reddys Laboratories Louisiana LLC

NCT06538077 / Not yet recruitingNot ApplicableIIT

Branch Chain Amino Acids vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of Hepatic Encephalopathy: Double-blind Placebo-controlled Multicentric Randomized Controlled Trial

Rationale
* Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health.
* A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cognitive function.
Novelty:
* This study is intended to investigate the role of BCAA vs rifaximin as the ideal second-line therapy for HE management, recurrence, and overall health, including cognitive function, depression and anxiety.
* The head-to-head comparison of BCAA+lactulose+ pill-placebo vs rifaximin+ lactulose+ powder-placebo ensures minimization of bias and has adequate power to determine rates of recurrence,
Objectives:
* To assess the 1st breakthrough episode of HE during 6months in BCAA vs rifaximin groups as ideal secondary prophylaxis in HE. Methodology
* Double-blind placebo-controlled double-dummy randomized trial of BCAA supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of OHE. Expected Outcome
* Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent, and cost of therapy needs to be optimized.
* Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function, and overall health-related quality of life(HRQOL).
* Creation of a management algorithm based deductive models incorporating etiology and severity of liver disease, cognitive performance, sarcopenia, and ammonia, and neuropsychiatric impact of using BCAA vs Rifaximin will be created.

Start Date01 Aug 2024

Sponsor / Collaborator

Post Graduate Institute of Medical Education & Research

[+1]

100 Clinical Results associated with Lactulose

100 Translational Medicine associated with Lactulose

100 Patents (Medical) associated with Lactulose

2,890

Literatures (Medical) associated with Lactulose

01 Dec 2024·AMERICAN JOURNAL OF CLINICAL NUTRITION

A cross-sectional study of associations between the 13C-sucrose breath test, the lactulose rhamnose assay, and growth in children at high risk of environmental enteropathy

Article

Author: Devi, Sarita ; Huq, Sayeeda ; Yazbeck, Roger ; Owino, Victor O ; Brouwer, Andrew F ; Lee, Gwenyth O. ; Konyole, Silvenus Ochieng ; Paredes-Olortegui, Maribel ; Owino, Victor O. ; Morrison, Douglas J ; Kelly, Paul ; Brouwer, Andrew F. ; Kosek, Margaret N. ; Morrison, Douglas J. ; Kosek, Margaret N ; Lee, Gwenyth O ; Shivakumar, Nirupama

BACKGROUND:

Environmental enteropathy' (EE) is common among children who are highly exposed to enteric pathogens in low-resource settings. We optimized and validated a stable isotope-based breath test of intestinal sucrase activity (¹³C-SBT) as a noninvasive test of carbohydrate digestion and metabolism.

OBJECTIVES:

The primary objective of this study was to assess the relationship between the ¹³C-SBT and the lactulose/rhamnose ratio (LR) and growth in children. Secondary objectives were to assess the relationship between the ¹³C-SBT and additional biomarkers of EE. We also characterized the relationship between the ¹³C-SBT and child sex and dietary diversity, as well as household socio-economic status and food security.

METHODS:

In this cross-sectional study, 12-to-15-mo-old children were recruited in Bangladesh, India, Kenya, and Peru. Children were assessed with a 4-h ¹³C-SBT and a 90-min LR test. Plasma was collected to determine the citrulline and kynurenine/tryptophan ratio. Length and weight were measured, and other variables were assessed through questionnaires. For a subset of children, anthropometry was re-measured after 3 mo. Linear regression was used to examine associations corresponding to each objective.

RESULTS:

Three sites generated ¹³C-SBT breath curves that enabled pooled analysis. Differences in ¹³C-SBT breath curves, LR ratios, and other EE biomarkers were observed between sites. No associations were observed for ¹³C-SBT summary measures and LR or child growth [e.g., the association between LR and cumulative percent dose recovered at 90 min: -0.39; 95% confidence interval (CI): -1.79, 0.70]. Length-for-age and weight-for-age were positively associated with the time to 50% of dose recovered (0.05; 95% CI: 0.01, 0.09, and 0.05; 95% CI: 0.02, 0.07, respectively), and dietary diversity was associated with time at which 50% of the dose recovered by 240 min is recovered and cumulative percent dose recovered at 90 min (-0.10; 95% CI: -0.18, -0.02 and 2.67; 95% CI: 0.47, 4.88, respectively).

CONCLUSIONS:

In children at risk of EE, there were no associations between the ¹³C-SBT, LR, or other EE biomarkers encompassing different pathophysiological domains of EE. This trial was registered at clinicaltrials.gov as NCT04109352.

01 Dec 2024·Annals of Hepatology

The burden of hepatic encephalopathy and the use of albumin as a potential treatment

Review

Author: Caraceni, Paolo ; Pompili, Enrico ; Bajaj, Jasmohan S

As a potential sequela of cirrhosis, hepatic encephalopathy (HE) significantly impacts the lives of patients and caregivers and places a substantial burden on the healthcare system. With an increasing incidence over time and a cumulative effect on cognition, HE adversely effects quality of life, morbidity and mortality in patients with cirrhosis. HE can range from minimal or covert (MHE/CHE) to overt and symptomatic (OHE). HE has profound impacts on the health and wellbeing of patients and their families and caregivers. Effective treatments could improve the quality of life for all those affected. In this article, we discuss the existing treatments for HE and focus on the potential role of albumin in the treatment of HE. Currently approved therapies for HE (lactulose and rifaximin) are focused on decreasing the formation of ammonia in the gastrointestinal tract. Among the many agents with alternative mechanisms being investigated for treatment of HE, albumin has been studied in clinical trials with acute (≤ 3 days), short-term (up to 2 weeks) prolonged (> 2 weeks) and long-term administration (months). Current studies indicate that acute or short-term administration of albumin does not provide significant benefit for patients with OHE. However, there is increasing evidence that prolonged or long-term albumin therapy can help improve cognition in OHE and prevent recurrence. Additional studies are needed to substantiate these positive findings for longer term administration of albumin in HE and to increase our comprehension of the pharmacologic basis of the effects of albumin.

30 Nov 2024·Clinical Endoscopy

Novel regimen for colonoscopy bowel preparation with oral lactulose: a prospective comparative study

Article

Author: Arantes, Vitor N ; Carvalho, Danilo ; Ramos, Josué Aliaga

Background/Aims: Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation; however, due to the necessity of a large volume, patient tolerance is impaired. Therefore, lactulose is a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy and safety of lactulose-based bowel preparations in comparison with PEG for colonoscopy.Methods: This is a prospective, non-blinded, comparative study. Outpatients were randomly divided into two groups: group 1 (111 patients), PEG; and group 2 (111 patients), lactulose. The following clinical outcomes were assessed in each group: degree of bowel clearance using the Boston bowel preparation score, colorectal polyp detection rate, adenoma detection rate, tolerability, and side effects.Results: The rate of inadequate bowel preparation was 8.1% and 1.8% for the PEG and lactulose groups, respectively (p=0.030). The Boston bowel preparation score for the entire colon was 7.34±1.17 and 8.36±1.09 for the PEG and lactulose groups, respectively (p<0.001). The satisfactory overall experience rates were 27.9% and 62.2% for the PEG and lactulose groups, respectively (p<0.001).Conclusions: The novel bowel preparation with oral lactulose was superior to that with PEG in terms of colon cleansing, adenoma detection rate, tolerance, and patient experience.

News (Medical) associated with Lactulose

08 Nov 2024

·www.drugs.com

American College of Gastroenterology, Oct. 25-30

The annual meeting of the American College of Gastroenterology was held from Oct. 25 to 30 in Philadelphia and attracted participants from around the world, including gastroenterology and digestive disease specialists and other health care professionals. The conference featured presentations focusing on clinical updates in gastroenterology and hepatology as well as the latest advances in digestive health and gastrointestinal disorders. In one study, Khaled Alsabbagh Alchirazi, M.D., of Aurora Healthcare in Brookfield, Wisconsin, and colleagues found that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are not associated with an increased risk for pancreatic cancer among patients with type 2 diabetes mellitus (T2DM). The authors evaluated the association between GLP-1 RAs and pancreatic cancer risk among T2DM patients. Deidentified electronic health records (EHRs) were used to identify patients with T2DM who were prescribed antidiabetic medications between 2005 and 2020 and had no prior antidiabetic drug use and no prior diagnosis of pancreatic cancer. The researchers compared GLP-1 RAs to other antidiabetic medications and found that T2DM patients on GLP-1 RAs did not have an increased incidence of pancreatic cancer. "Clinicians could consider GLP-1 RAs as a viable option for diabetes treatment, guiding more confident decision-making in long-term diabetes care," Alchirazi said. One author disclosed ties to Boston Scientific and Cook Endoscopy. Abstract No. 52 In another study, Temi Olasehinde, M.D., of Case Western Reserve University in Cleveland, and colleagues found that GLP-1 RAs may serve as protective agents against early-onset colorectal cancer (EO-CRC), which is relevant given the disease's rising incidence and mortality worldwide. The authors evaluated the impact of the use of GLP-1 RAs on EO-CRC among patients with T2DM. A retrospective cohort study was performed using data from deidentified EHRs. The researchers found that GLP-1 RA use was associated with a significantly decreased risk for EO-CRC development in patients with T2DM with or without obesity. "Our findings will need to be validated further in prospective studies," Olasehinde said. "However, it does show the potential for this agent to be used as a protective agent against EO-CRC, thereby adding to the growing body of research looking at preventative/risk-tailored strategies to decrease the risk of EO-CRC in this population." Abstract No. P2134 Jacqueline Khalil, D.O., of Case Western Reserve University/Metro Health in Beachwood, Ohio, and colleagues identified an association between hormone replacement therapy and an increased risk for developing irritable bowel syndrome (IBS), a risk that persisted over time. A population-based cohort study was performed using data from deidentified EHRs for postmenopausal women aged 50 years or older, with and without a prescription for hormone replacement therapy. The researchers found that hormone replacement therapy was associated with a higher risk for developing IBS. In addition, hormone replacement therapy correlated with elevated gastrointestinal symptoms, including abdominal distention and flatulence, increased medication utilization (particularly with medications prescribed to patients with IBS), and increased diagnostic testing. "These findings emphasize the importance of considering the potential consequences of hormone replacement therapy in postmenopausal women, particularly regarding IBS," Khalil said. "Clinicians should be cognizant about the gastrointestinal impact and effects when prescribing hormone replacement therapy." One author disclosed ties to Allurion, Bristol Myers Squibb, Johnson & Johnson, and Vibrant. Abstract No. P2357 Jasmohan S. Bajaj, M.D., of the Virginia Commonwealth University School of Medicine in Richmond, and colleagues found that rifaximin monotherapy is associated with a significantly lower rate of overt hepatic encephalopathy (OHE) recurrence and mortality among individuals with cirrhosis. The authors performed a post-hoc analysis of two randomized clinical trials involving patients with prior OHE. Specifically, they compared lactulose monotherapy and rifaximin monotherapy to each other; major outcomes were OHE recurrence, HE-related hospitalizations, and mortality at six months. The comparisons included cohorts of more than 280 patients across multiple centers worldwide. The researchers found that rifaximin monotherapy was tied to a lower rate of OHE recurrence and mortality. In addition, compared with the patients on rifaximin monotherapy, a greater proportion of patients on lactulose monotherapy had drug discontinuation due to diarrhea and other gastrointestinal-related adverse effects. "If confirmed, this could encourage the use of rifaximin alone rather than with lactulose therapy for prevention of HE recurrence and potentially a mortality benefit," Bajaj said. Several authors disclosed ties to pharmaceutical companies, including Salix Pharmaceuticals, which manufactures rifaximin. Abstract No. 9 ACG: GLP-1 RAs Tied to Lower Risk for Early-Onset Colorectal Cancer FRIDAY, Nov. 1, 2024 -- Glucagon-like peptide-1 receptor agonists can decrease the risk for developing early-onset colorectal cancer in patients with diabetes regardless of weight, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: 2000 to 2022 Saw Rise in Early-Onset CRC Mortality in the United States THURSDAY, Oct. 31, 2024 -- Early-onset colorectal cancer mortality rose in the United States over the past two decades, most notably in patients aged 20 to 44 years, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: Hormone Therapy Tied to Higher Risk for New Irritable Bowel Syndrome THURSDAY, Oct. 31, 2024 -- Hormone replacement therapy is associated with an increased risk for developing irritable bowel syndrome in postmenopausal women, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: Fewer Overt Hepatic Encephalopathy Episodes Seen With Rifaximin MONDAY, Oct. 28, 2024 -- For patients with a history of overt hepatic encephalopathy, rifaximin monotherapy results in significantly fewer overt hepatic encephalopathy episodes than lactulose monotherapy, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

06 Nov 2024

·www.prnewswire.com

CUMBERLAND PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG AND RARE PEDIATRIC DISEASE DESIGNATIONS FOR NEW TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

NASHVILLE, Tenn., Nov. 6, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, announced today that the United States (U.S.) Food and Drug Administration (FDA) granted Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Cumberland is completing the FIGHT DMD™ trial, a multicenter, double-blind, placebo-controlled Phase II study investigating the pharmacokinetics, safety and efficacy of once daily oral Ifetroban in patients with DMD. Results will be announced later this year. "For Duchenne muscular dystrophy, a devastating genetic disorder affecting young boys, securing both Orphan Drug and Rare Pediatric Disease Designations for Ifetroban from the FDA is a critical step forward," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "These designations not only recognize the urgent need for effective treatments but also provide vital support to accelerate research and development. These important regulatory milestones represent hope for families and a pathway to bring transformative medicines to a vulnerable patient population more quickly and efficiently." The U.S. FDA grants Rare Pediatric Disease Designation to incentivize drug development for life-threatening diseases affecting less than 200,000 children in the U.S. As these diseases pose unique challenges to drug development, special focus is needed to provide therapeutic options to these children. Companies that receive approval for a drug or biologic with this designation may be eligible for a voucher which may be redeemed for priority review of a different product. Additionally, this voucher may be transferred or sold to another sponsor. Orphan Drug Designation is granted by the U.S. FDA to encourage development of new therapies for rare diseases or conditions affecting fewer than 200,000 people in the U.S. This designation offers sponsors multiple incentives, which include exemption from user fees, tax credits for qualified clinical trials and potential market exclusivity for seven years following approval of the product. About Duchenne Muscular Dystrophy DMD is a rare and fatal genetic disorder which affects about 1 in every 3,300 male births worldwide. Characterized by mutations in the gene responsible for producing dystrophin, DMD causes damage to the skeletal and cardiac muscle of DMD patients, with cardiomyopathy recognized as the primary cause of death. Ifetroban is being evaluated to treat the heart disease associated with DMD, which has received limited attention with current therapies. About Ifetroban Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. Ifetroban exhibits high affinity for TPr on many cell types including cardiomyocytes, platelets, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. In several preclinical models of muscular dystrophy, including limb-girdle and Duchenne, ifetroban prevented cardiac fibrosis and cardiac dysfunction and improved mortality. Cumberland previously announced the acquisition of the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies. Cumberland is also evaluating ifetroban for systemic sclerosis and pulmonary fibrosis. The ongoing FIGHTING FIBROSIS Trial is a multicenter, randomized placebo-controlled Phase II study in patients with idiopathic pulmonary fibrosis (IPF), a progressive interstitial lung disease. IPF is marked by inflammation and fibrosis of the lungs, resulting in rapidly declining lung function and reduced survival within five years of diagnosis. The study is evaluating the safety and efficacy of once daily oral Ifetroban for 52 weeks. About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high-quality prescription brands to improve patient care. The Company develops, acquires, and commercializes brands for the hospital acute care, gastroenterology and rheumatology market segments. The Company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) Injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) Injection, for the treatment of pain and fever; Vaprisol® (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; Vibativ® (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; Kristalose® (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation; and Sancuso® (granisetron) Transdermal delivery system, for the treatment of nausea and vomiting associated with chemotherapy. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company's website . About Cumberland Emerging Technologies Cumberland Emerging Technologies, Inc. () is a joint initiative between Cumberland Pharmaceuticals Inc., Vanderbilt University, Launch Tennessee and WinHealth Pharma. The mission of CET is to bring biomedical technologies and products conceived at Vanderbilt and other regional research centers to the marketplace. CET helps manage the development and commercialization process for select projects and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products. CET's Life Sciences Center, located in Nashville, Tennessee, provides laboratory space, equipment and infrastructure to early-stage life sciences companies. Forward-Looking Statements This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. SOURCE Cumberland Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Orphan DrugAcquisitionClinical Result

05 Nov 2024

·www.prnewswire.com

New Study Compares Caldolor® (ibuprofen injection) to ketorolac

– Real World Study Compared Over 150,000 Adult & Pediatric Patients – – Caldolor Associated with Fewer Adverse Drug Reactions – – Caldolor also Improved Healthcare Utilization – NASHVILLE, Tenn., Nov. 5, 2024 /PRNewswire/ -- Specialty pharmaceutical company Cumberland Pharmaceuticals (Nasdaq: CPIX) today announced the publication of new real-world outcomes research demonstrating the safety and healthcare resource advantages of its Caldolor (ibuprofen) injection over ketorolac in both adult and pediatric populations. The study, published in Frontiers of Pain Research, provides compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions (ADRs) and improved healthcare utilizations when compared to ketorolac. This extensive, retrospective, payer database analysis evaluated the records of over 17 million patients who had received either ketorolac or Caldolor. Ultimately, 31,046 Caldolor and 124,184 ketorolac adult patients were selected and compared for ADRs and subsequent healthcare resource utilization, which includes inpatient, outpatient and emergency department visits as well as all procedures and prescriptions during the follow up time of 29 days. An additional 5,579 pediatric patients were identified in each arm and compared in a separate claims analysis. Key findings reveal that, in adults, Caldolor was associated with a 45% reduction in renal dysfunction (p<0.001) and a 78% decrease in hematuria rates (p<0.001) when compared to ketorolac. Notably, patients also experienced fewer gastrointestinal complications as well as reduced headaches, nausea and abdominal pain. Among pediatric patients, the results showed Caldolor was associated with a 51-65% lower rate of ADRs, including headache and nausea, with 95% confidence intervals supporting clinical significance. Caldolor also demonstrated a positive impact on healthcare resource utilization (HCRU) when compared to ketorolac, with decreased emergency room and outpatient visits, as well as a shortened hospital length of stay for both adults and children. "These findings underscore Caldolor's potential to improve patient care by reducing their treatment complications, while also delivering potential savings for healthcare systems through decreased hospital readmissions and shortened treatment times," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. About Caldolor® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit . About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website . Forward-Looking Statements This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. SOURCE Cumberland Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 2

100 Deals associated with Lactulose

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KEGG	Wiki	ATC	Drug Bank
D00352	Lactulose	A06AD11	DB00581

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hyperammonemia	JP	Sanwa Kagaku Kenkyusho Co., Ltd.	21 Sep 2018
Chronic constipation	AU	Arrotex Pharmaceuticals Pty Ltd.Startup	13 Feb 2014
Hepatic Encephalopathy	AU	Arrotex Pharmaceuticals Pty Ltd.Startup	13 Feb 2014
Constipation	NL	-	01 May 1964

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Diseases	Phase 2	US	Cumberland Pharmaceuticals, Inc.	01 Apr 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05061992 (CTgov)	Phase 2/3	Fibrosis	56	Lactulose (Lactulose)	zayminwjfx(nznkocbfyp) = qxcgbxfgfs crrzoexcph (gbdywndnvt, naktvwocvm - drafzedadf) View more	-	21 Nov 2023
				placebo (No Treatment)	zayminwjfx(nznkocbfyp) = qhfnvglifq crrzoexcph (gbdywndnvt, ydrlcjrrul - zpoamxtisd) View more
NCT05687409 (Pubmed \| Front Microbiol)	Phase 4	Fibrosis	-	Synbiotic (lactulose, Clostridium butyricum, Bifidobacterium longum infantis)	szxhaxozqr(hfwqxpitkf) = jatphjtuxd zpvdsulzxp (yjlslvitrc )	Positive	01 Jan 2023
EASL2022	Not Applicable	Fibrosis	-	Lactulose	-	-	24 Jun 2022
				Lactulose + Rifaximin-alpha
NCT01842581 (CTgov)	Phase 4	Hepatic Encephalopathy \| Fibrosis	222	Rifaximin (Rifaximin 550 mg BID)	dymriwhrrw(ccvrdqjvus) = ljtmrrahgc ihbbhxxiyo (kfnpgbyihh, labhrlagfb - etczhqlrjr) View more	-	09 Sep 2019
				Rifaximin+Lactulose (Rifaximin 550 mg BID + Lactulose)	dymriwhrrw(ccvrdqjvus) = eklksrxarl ihbbhxxiyo (kfnpgbyihh, qrehlwlgig - fadgdacked) View more
Pubmed \| J Gastroenterol Hepatol	Not Applicable	Hepatic Encephalopathy	120	Lactulose plus albumin	pulymlgaeb(vusofozhcq) = ebigjpfbnc gemtejqhbb (xwfrmicfyd ) View more	Positive	01 Jun 2017
				Lactulose alone	pulymlgaeb(vusofozhcq) = xnafuufrsq gemtejqhbb (xwfrmicfyd ) View more
NCT02123017 (CTgov)	Phase 2	-	32	90 grams of Crystalline Lactulose (90 Grams of Crystalline Lactulose)	nxcxxzrukq(vieyejrigr) = rilsahytvl ibexkmovbj (ncgfjdxcek, eniwvmajnv - ueatyoxehx) View more	-	24 Feb 2016
				135 grams of Crystalline Lactulose (135 Grams of Crystalline Lactulose)	nxcxxzrukq(vieyejrigr) = jiejvtuyzb ibexkmovbj (ncgfjdxcek, yxisnzagtc - kwiuesohlm) View more
ECCO2016	Not Applicable	Colitis, Ulcerative	96	lactulose (Ulcerative colitis in remission)	bcnhtwnzej(gppeiwbdga) = edcandyjvo pfkpoyldrv (xgrpdwinyp )	Positive	12 Feb 2016
				lactulose (Active ulcerative colitis)	bcnhtwnzej(gppeiwbdga) = heflzjpfbv pfkpoyldrv (xgrpdwinyp )
UEGW2015	Not Applicable	Hepatic Encephalopathy	126	Lactulose	momywbykqz(xiyinawfov) = mhnphfjwss epelzfkeky (ciopnrdyxg ) View more	Negative	01 Oct 2015
				Rifaximin	momywbykqz(xiyinawfov) = dsmpsseizl epelzfkeky (ciopnrdyxg ) View more
NCT01283152 (HELP, Pubmed \| JAMA Intern Med)	Not Applicable	Hepatic Encephalopathy	50	Polyethylene glycol 3350-electrolyte solution (PEG)	qsebeunkfx(torguhvpil) = cvpxdnlbul zayxaabttr (fnbwfxhojl )	Positive	01 Nov 2014
				Lactulose	qsebeunkfx(torguhvpil) = jnihkvhsfc zayxaabttr (fnbwfxhojl )
NCT00712543 (CTgov)	Phase 4	Constipation	50	lactulose (Powder, Then Liquid Lactulose)	cmjdqjqkwp(gkzijsldpo) = xjajwtsfcy obsgmlyomi (pekxwpuswk, jrrjevxpdz - gkfgogvzmb) View more	-	27 Sep 2011
				lactulose (Liquid, Then Powder Lactulose)	cmjdqjqkwp(gkzijsldpo) = cbjzqzlcsl obsgmlyomi (pekxwpuswk, uopzdvqzld - zkuedttuhi) View more

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis