NEW REPORT SUPPORTS USE OF CALDOLOR® AS A STANDARD OF CARE ACROSS PATIENT POPULATIONS
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Insights
The recent findings concerning intravenous ibuprofen (IVIB) as detailed by Cumberland Pharmaceuticals signify a potential shift in the standard pain and fever management protocols. The emphasis on IVIB's efficacy and safety in a broad age range, from infants to adults, indicates a widening market for the product. From an industry perspective, the ability to market a non-opioid pain management solution is timely, given the current opioid crisis. This positions Cumberland Pharmaceuticals advantageously within the specialty pharmaceutical sector, potentially increasing its market share and investor interest.
Moreover, the reported benefits of IVIB, such as reducing the need for opioids and providing effective pain management, could lead to cost savings for healthcare providers by curtailing the economic burden associated with opioid addiction and its related healthcare costs. The market is increasingly receptive to pharmaceutical innovations that offer safer alternatives to opioids and the positive data could enhance the company's reputation and credibility within the medical community.
The implications of Cumberland Pharmaceuticals' findings on healthcare policy are significant. As healthcare systems grapple with the opioid epidemic, evidence-based alternatives such as IVIB can influence treatment guidelines and insurance coverage decisions. The emphasis on multimodal pain management reflects a broader trend in healthcare policy towards comprehensive and preventative care strategies. If IVIB becomes a recommended standard of care, it could lead to regulatory endorsements and a shift in prescribing behaviors, which would have a profound impact on public health outcomes and pharmaceutical business strategies alike.
However, the widespread adoption of IVIB hinges on continued positive outcomes and cost-effectiveness analysis. Payers and policymakers will scrutinize the long-term benefits and potential risks associated with IVIB's use in various populations. The company's engagement with regulatory bodies and advocacy for inclusion in treatment protocols could be a pivotal factor in its commercial success.
As a clinical pharmacist, it's essential to evaluate the therapeutic benefits and practical applications of IVIB in real-world settings. The reported reduction in opioid use and effective pain control in postoperative and emergency department scenarios is promising. These outcomes suggest that IVIB could be integrated into hospital formularies and become a standard preoperative medication to manage pain, which would enhance patient recovery and experience.
Additionally, the unique approval of IVIB for use in young pediatric patients addresses a significant unmet need in pain management for this vulnerable population. It is incumbent upon pharmacy and therapeutics committees to consider these findings and weigh the benefits against any potential adverse effects associated with NSAIDs. The role of IVIB in multimodal regimens could redefine hospital protocols, potentially leading to an increase in demand for the product and an associated uptick in the company's stock performance.
Growing data shows intravenous ibuprofen is safe and effective for the treatment of pain and fever in adults, children and infants
The report, published in Anesthesiology News, General Surgery News and Pharmacy Practice News, highlights the need for the prudent and careful management of pain, particularly as the prescription of opioids for pain treatment has become commonplace, often leading to dependence and misuse.
"My hope is that this Special Report will emphasize the use of Caldolor as a foundation for multimodal pain management, while also helping to address the opioid epidemic," said Michael W. Lew, M.D., Clinical Professor and Past Chair for the Department of Anesthesiology and Perioperative Medicine at the City of Hope Cancer Center.
As part of a comprehensive safety and efficacy developmental plan, IVIB was studied in various treatment areas, including surgical pain, fever and nonsurgical acute pain. The results, which are highlighted in the report, show it's a safe and effective treatment for pain and fever in adults, children and infants as young as 3 months of age.
Takeaways from the report note that:
- IVIB results in significant reduction in temperature compared with placebo (in adults) and with acetaminophen (in pediatric patients).
- Administration of the product prior to surgery leads to patients waking up in significantly less postsurgical pain, while also lessening or even eliminating the need for opioids.
- IVIB use in the hospital ED for acute pain can minimize opioid requirements, while achieving pain control.
- IVIB is the only non-opioid injectable analgesic approved for use in children as young as 3 months of age.
- IVIB should be considered a foundation for any multimodal pain regimen.
"Pain management has become one of the most common health care problems," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "As this new report states, comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control, while minimizing the need for opioids. A non-steroidal anti-inflammatory drug, or NSAID, such as Caldolor has become a cornerstone for many treatment paradigms, and we are continually encouraged by the growing database from our studies of the product in patients of all ages."
To learn more about the clinical results demonstrated with IVIB and read the full report at https://www.pharmacypracticenews.com/Monographs-and-Whitepapers/Article/02-24/Intravenous-Ibuprofen-for-the-Treatment-of-Pain-and-Fever-An-Update/72896.
For full prescribing and safety information, visit www.caldolor.com.
About Caldolor®
Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the 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 as well as 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 www.caldolor.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in
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;
- Omeclamox®-Pak, (omeprazole, clarithromycin, amoxicillin) oral, for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
- 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. Investigational new study applications have been cleared by the FDA enabling Cumberland to launch clinical studies in each of these areas.
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 at 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
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SOURCE Cumberland Pharmaceuticals Inc.
FAQ
Is intravenous ibuprofen safe and effective for pain and fever treatment in adults, children, and infants?
What are the key takeaways from the report regarding IVIB?
Who is the Clinical Professor and Past Chair mentioned in the PR?
What is the CEO of Cumberland Pharmaceuticals, A.J. Kazimi's view on pain management?
What type of drug is Caldolor?
