NEW STUDY FINDS CALDOLOR® SAFE AND EFFECTIVE FOR OPIOID-SPARING PAIN MANAGEMENT IN OLDER ADULTS

Rhea-AI Summary

Cumberland Pharmaceuticals (NASDAQ: CPIX) announced positive results from a study of Caldolor® (intravenous ibuprofen) in patients aged 60 and older. The analysis, involving data from four clinical studies with 1,041 patients, demonstrated significant benefits in pain management. Key findings showed Caldolor reduced pain by 24% at rest and 20% with movement between 6-24 hours post-surgery compared to placebo. Notably, the treatment led to a 23.2% reduction in post-operative morphine requirements. The safety profile was favorable, with Caldolor-treated patients experiencing fewer adverse events (55%) compared to placebo (90%). The study is particularly significant as it addresses pain management needs in older adults, who comprise nearly one-third of ambulatory surgeries and are often underrepresented in clinical trials.

Positive

• 23.2% reduction in post-operative morphine requirement (p=0.031)
• 24% reduction in pain at rest and 20% reduction in pain with movement
• Lower incidence of adverse events in Caldolor-treated patients (55%) vs placebo (90%)
• No significant differences in safety profiles between older and younger patients
• No notable increases in gastrointestinal, renal, cardiovascular or bleeding adverse events

Negative

• None.

Insights

Clinical Pharmacologist

Cumberland's IV ibuprofen shows 23% reduction in opioid use for older adults with favorable safety profile, expanding its clinical utility.

Cumberland's post-hoc analysis of Caldolor® (intravenous ibuprofen) demonstrates significant clinical benefits in the vulnerable 60+ population. The data shows a 24% reduction in pain at rest and 20% reduction in pain with movement between 6-24 hours post-surgery compared to placebo. Most impressive is the 23.2% reduction in total post-operative morphine requirements (p=0.031).

The safety profile is particularly noteworthy for older adults who typically experience heightened sensitivity to medications. Adverse events were substantially lower in the Caldolor group (55% vs 90% in placebo), with no concerning increases in typical NSAID-associated risks like GI, renal, cardiovascular events or bleeding complications.

This represents a meaningful advancement in geriatric pain management. The opioid-sparing effect addresses a critical clinical need as older patients face higher risks from opioid-related complications including respiratory depression, cognitive impairment, and falls. With nearly one-third of ambulatory surgeries performed on older patients, this evidence fills an important gap in clinical literature, as this demographic is often underrepresented in trials.

The study validates Caldolor's role in multi-modal pain management protocols specifically for older surgical patients. Combined with Cumberland's previous infant safety study, they've now demonstrated Caldolor's utility across the full age spectrum - a comprehensive clinical profile that significantly enhances the product's positioning in the hospital formulary decision-making process.

Analysis Shows 23% Reduction in Morphine Use with Favorable Safety Profile in Patients 60 Years of Age and Older

NASHVILLE, Tenn., May 27, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced the publication of its study investigating Caldolor^® (intravenous ibuprofen) in older patients. The analysis evaluated the safety and efficacy of Caldolor for the management of pain and fever in patients 60 years of age and older. It marks an important advancement in pain management for older individuals, as it's one of the first studies specifically evaluating Caldolor in this vulnerable population.

Pain management in older patients presents unique challenges due to their increased sensitivity to opioid analgesics and higher risk of side effects. Nearly one-third of all ambulatory surgeries are performed on older patients, yet this population is often underrepresented in clinical trials, highlighting an important medical need addressed in this study.

A post-hoc subgroup analysis was performed using data from four prospective clinical studies in which Caldolor was administered for the treatment of pain and/or fever in hospitalized patients. The efficacy analysis included 591 patients from two placebo-controlled trials, with safety assessed across all 1,041 patients.

"These results provide compelling evidence that intravenous ibuprofen is both safe and effective for managing post-operative pain in older patients," said Dr. Tong Joo Gan, MD, MBA, Division Head of Anesthesiology, Critical Care and Pain Medicine at MD Anderson Cancer Center. "The significant reduction in opioid consumption is particularly important for this vulnerable population, who face heightened risks from opioid-related adverse events including falls, respiratory depression and cognitive impairment."

"We've long recognized the need for effective non-opioid analgesic options for older surgical patients," noted Dr. Stephen Southworth, MD, four-time board-certified orthopaedic surgeon at Orthopaedic Institute of North Mississippi. "This analysis demonstrates that Caldolor not only reduces pain intensity but also decreases the need for opioid medication, potentially improving overall recovery outcomes in this growing demographic. The majority of pain from injury and surgery is inflammatory in nature and is unaddressed by opioids which is why Caldolor has become a cornerstone of our multi-modal pain regimen."

Key findings include:

• Caldolor treatment resulted in a 24% reduction in pain at rest (p=0.008) and a 20% reduction in pain with movement (p=0.001) between 6 and 24 hours post-surgery compared with placebo.
• Caldolor treatment led to a 23.2% reduction in total post-operative morphine requirement (p=0.031) compared with placebo.
• The incidence of adverse events was lower in Caldolor-treated patients compared to placebo (55% vs 90% in older patients).
• No notable increases in gastrointestinal, renal, cardiovascular or bleeding adverse events were observed with Caldolor treatment.
• There were no significant differences in the efficacy and safety profiles of Caldolor in older patients compared with those in younger patients, despite the higher cumulative doses of the product administered to older patients.

"These impressive results validate our commitment to providing safe and effective pain management options across diverse patient populations," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "As the global aging population continues to grow, there is an increasing need for evidence-based treatment approaches specifically evaluated in older individuals. This analysis demonstrates that Caldolor can be an important component of multimodal analgesia regimens for older patients, supporting our mission to improve patient care through innovative therapies."

Today's announcement builds on Cumberland's ongoing commitment to expanding the clinical applications of Caldolor. In June 2023, the company announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborn infants, which supported the FDA approval of Caldolor for use in infants 3 to 6 months of age. With these latest findings in older patients, Cumberland continues to demonstrate Caldolor's safety and efficacy across the full age spectrum, from infants to older adults.

Caldolor is FDA-approved for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever in adults and pediatric patients three months and older. This new data supports its use specifically in the older patient population. Next steps include further outreach to health care providers treating older patients to share these important findings.

More information regarding Cumberland's approved products can be found at www.cumberlandpharma.com.

References:

Gan TJ, et al. The Safety and Efficacy of Intravenous Ibuprofen in Older Patients: A Retrospective Subgroup Analysis. Clinical Therapeutics 2025.

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 Phase 2 clinical studies evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy, systemic sclerosis and idiopathic pulmonary fibrosis.

For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website: www.cumberlandpharma.com.

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. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. 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 operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. 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.

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SOURCE Cumberland Pharmaceuticals Inc.

FAQ

What were the key findings of Cumberland Pharmaceuticals' (CPIX) Caldolor study in older adults?

The study showed Caldolor reduced post-operative morphine requirements by 23.2%, decreased pain by 24% at rest and 20% with movement, and demonstrated fewer adverse events (55%) compared to placebo (90%) in patients 60 years and older.

How effective is CPIX's Caldolor in reducing opioid use for older patients?

Caldolor demonstrated a significant 23.2% reduction in total post-operative morphine requirements compared to placebo in patients 60 years and older.

What is the safety profile of Cumberland's Caldolor in elderly patients?

Caldolor showed a favorable safety profile with lower adverse events (55%) compared to placebo (90%), and no notable increases in gastrointestinal, renal, cardiovascular or bleeding events.

How does Caldolor's effectiveness compare between older and younger patients?

The study found no significant differences in the efficacy and safety profiles of Caldolor between older and younger patients, despite higher cumulative doses in older patients.

What is the FDA approval status of Cumberland Pharmaceuticals' Caldolor?

Caldolor is FDA-approved for managing mild to moderate pain, moderate to severe pain as an opioid adjunct, and fever reduction in adults and pediatric patients three months and older.