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. 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For many people with migraine, it can be difficult to find a treatment that is effective and reliable, and information on how medications compare to one another is lacking. A new study draws data from nearly 300,000 people using a smartphone app to help people make decisions about their medications. The study found that certain migraine medications like triptans, ergots and anti-emetics may be two to five times more effective than ibuprofen for treating migraine attacks, according to new research. For many people with migraine, it can be difficult to find a treatment that is effective and reliable, and information on how medications compare to one another is lacking. A new study draws data from nearly 300,000 people using a smartphone app to help people make decisions about their medications. The study found that certain migraine medications like triptans, ergots and anti-emetics may be two to five times more effective than ibuprofen for treating migraine attacks, according to new research published in the November 29, 2023, online issue of Neurology®, the medical journal of the American Academy of Neurology. Migraine attacks are characterized by intense throbbing head pain, sensitivity to light and sound, nausea or vomiting. Previous research has shown migraine can also be associated with cognitive issues. All of these symptoms may impact a person's quality of life and productivity. "There are many treatment options available to those with migraine. However, there is a lack of head-to-head comparisons of the effectiveness of these treatment options," said study author Chia-Chun Chiang, MD, of the Mayo Clinic in Rochester, Minnesota, and member of the American Academy of Neurology. "These results confirm that triptans should be considered earlier for treating migraine, rather than reserving their use for severe attacks." For the study, researchers included over 3 million migraine attacks from nearly 300,000 users that were self-reported by people using a smartphone app during a six-year period. The app allows users to monitor the frequency of migraine attacks, triggers, symptoms and medication effectiveness. For those migraine attacks, participants entered 4.7 million treatment attempts with various medications into the app. They recorded in the app whether a medication was helpful or not. Researchers then used that information to calculate the effectiveness of each drug compared to ibuprofen. Researchers looked at a total of 25 medications among seven drug classes. Different dosages of medication and formulas of each medication were combined in this analysis. The study found that the top three classes of medications more effective than ibuprofen were triptans, ergots and anti-emetics. Triptans were five times more effective than ibuprofen, ergots were three times more effective and anti-emetics were two and a half times more effective. When looking at individual medications, the top three were eletriptan which was six times more effective than ibuprofen, zolmitriptan which was five and a half times more effective and sumatriptan which was five times more effective. Researchers found that when using eletriptan, participants found it helpful 78% of the time. Zolmitriptan was helpful 74% of the time and sumatriptan was helpful 72% of the time. Ibuprofen was helpful 42% of the time. Researchers also looked at other groups of medication such as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs other than ibuprofen were 94% more effective than ibuprofen. Participants found ketorolac helpful 62% of the time, indomethacin was helpful 57% of the time, and diclofenac was helpful 56% of the time. However, acetaminophen was helpful 37% of the time and found to be 17% less effective than ibuprofen when used for treating migraines. Additionally, a common combination of medications used to treat migraine, aspirin, acetaminophen and caffeine was also evaluated and found to be 69% more effective than ibuprofen. "For people whose acute migraine medication is not working for them, our hope is that this study shows that there are many alternatives that work for migraine, and we encourage people to talk with their doctors about how to treat this painful and debilitating condition," said Chiang. A limitation of the study was evaluations of medications could be influenced by a user's expectations of the medication or the dosage they took. Another limitation was that newer migraine medications, gepants and ditans, were not included in the study due to the low amount of data when the study was conducted and lack of availability in many countries. The study was supported by the Kanagawa University of Human Services.