New Study Compares Caldolor® (ibuprofen injection) to ketorolac
Cumberland Pharmaceuticals (Nasdaq: CPIX) announced new research comparing Caldolor (ibuprofen injection) to ketorolac in over 150,000 patients. The study, published in Frontiers of Pain Research, analyzed 31,046 Caldolor and 124,184 ketorolac adult patients, plus 5,579 pediatric patients in each arm. Results showed Caldolor associated with 45% reduction in renal dysfunction and 78% decrease in hematuria rates in adults compared to ketorolac. In pediatric patients, Caldolor showed 51-65% lower adverse drug reaction rates. The medication also demonstrated improved healthcare resource utilization with decreased emergency room visits, outpatient visits, and shorter hospital stays.
Cumberland Pharmaceuticals (Nasdaq: CPIX) ha annunciato una nuova ricerca che confronta Caldolor (iniezione di ibuprofene) con il ketorolac in oltre 150.000 pazienti. Lo studio, pubblicato in Frontiers of Pain Research, ha analizzato 31.046 pazienti adulti trattati con Caldolor e 124.184 pazienti adulti trattati con ketorolac, oltre a 5.579 pazienti pediatrici in ciascun braccio. I risultati hanno mostrato che Caldolor è associato a una riduzione del 45% della disfunzione renale e a una decremento del 78% nelle rate di ematuria negli adulti rispetto al ketorolac. Nei pazienti pediatrici, Caldolor ha mostrato una riduzione delle reazioni avverse ai farmaci del 51-65%. Il medicinale ha inoltre dimostrato un miglior utilizzo delle risorse sanitarie, con una diminuzione delle visite al pronto soccorso, delle visite ambulatoriali e un soggiorno ospedaliero più breve.
Cumberland Pharmaceuticals (Nasdaq: CPIX) anunció una nueva investigación que compara Caldolor (inyección de ibuprofeno) con ketorolaco en más de 150,000 pacientes. El estudio, publicado en Frontiers of Pain Research, analizó a 31,046 pacientes adultos tratados con Caldolor y a 124,184 pacientes adultos tratados con ketorolaco, además de 5,579 pacientes pediátricos en cada grupo. Los resultados mostraron que Caldolor está asociado con una reducción del 45% en la disfunción renal y una disminución del 78% en las tasas de hematuria en adultos en comparación con ketorolaco. En pacientes pediátricos, Caldolor mostró tazas de reacciones adversas a medicamentos entre el 51-65% más bajas. El medicamento también demostró un mejor uso de los recursos de atención médica, con menos visitas a urgencias, menos visitas ambulatorias y estancias hospitalarias más cortas.
컴벌랜드 제약 (Nasdaq: CPIX)는 150,000명 이상의 환자를 대상으로 칼돌로르 (이부프로펜 주사)와 케토롤락을 비교한 새로운 연구 결과를 발표했습니다. Frontiers of Pain Research에 발표된 이 연구는 31,046명의 성인 칼돌로르 환자와 124,184명의 케토롤락 환자, 그리고 각 그룹에 대해 5,579명의 소아 환자를 분석했습니다. 결과는 칼돌로르가 성인에서 케토롤락에 비해 신장 기능 저하 45% 감소 및 혈뇨 비율 78% 감소와 관련이 있음을 보여주었습니다. 소아 환자에서는 칼돌로르가 51-65% 낮은 약물 부작용 비율을 보였습니다. 이 약물은 또한 응급실 방문, 외래 진료 방문 및 병원 체류 기간이 줄어든 의료 자원 활용 개선도 입증했습니다.
Cumberland Pharmaceuticals (Nasdaq: CPIX) a annoncé une nouvelle recherche comparant Caldolor (injection d'ibuprofène) au kétorolac chez plus de 150 000 patients. L'étude, publiée dans Frontiers of Pain Research, a analysé 31 046 patients adultes ayant reçu du Caldolor et 124 184 patients adultes ayant reçu du kétorolac, ainsi que 5 579 patients pédiatriques dans chaque groupe. Les résultats ont montré que le Caldolor était associé à une réduction de 45% de la dysfonction rénale et à une diminution de 78% des taux d'hématurie chez les adultes par rapport au kétorolac. Chez les patients pédiatriques, le Caldolor a montré des taux de réactions indésirables médicamenteuses inférieurs de 51 à 65 %. Le médicament a également démontré une meilleure utilisation des ressources de santé avec une diminution des visites aux urgences, des visites en ambulatoire et une durée de séjour hospitalier plus courte.
Cumberland Pharmaceuticals (Nasdaq: CPIX) hat eine neue Forschung angekündigt, die Caldolor (Ibuprofen-Injektion) mit Ketorolac bei über 150.000 Patienten verglichen hat. Die Studie, die in Frontiers of Pain Research veröffentlicht wurde, analysierte 31.046 erwachsene Patienten, die mit Caldolor behandelt wurden, und 124.184 erwachsene Patienten, die mit Ketorolac behandelt wurden, sowie 5.579 pädiatrische Patienten in jeder Gruppe. Die Ergebnisse zeigten, dass Caldolor mit einer 45%igen Reduktion von Nierenfunktionsstörungen und einer 78%igen Verringerung der Hämaturierate bei Erwachsenen im Vergleich zu Ketorolac assoziiert war. Bei pädiatrischen Patienten zeigte Caldolor eine 51-65% niedrigere Rate an unerwünschten Arzneimittelwirkungen. Das Medikament zeigte auch eine verbesserte Nutzung von Gesundheitsressourcen mit weniger Notaufbesuchen, ambulanten Besuchen und kürzeren Krankenhausaufenthalten.
- 45% reduction in renal dysfunction compared to ketorolac in adults
- 78% decrease in hematuria rates versus ketorolac
- 51-65% lower adverse drug reaction rates in pediatric patients
- Reduced emergency room and outpatient visits
- Shortened hospital length of stay for both adults and children
- None.
Insights
The real-world study comparing Caldolor to ketorolac presents significant clinical and commercial implications. The analysis of over 150,000 patients demonstrates Caldolor's superior safety profile with a
The reduced healthcare resource utilization, including fewer emergency room visits and shorter hospital stays, positions Caldolor as a cost-effective alternative to ketorolac. This data could drive increased adoption among healthcare providers and payers, potentially expanding Cumberland's market share in the injectable pain management segment.
For investors, this peer-reviewed evidence strengthens Caldolor's competitive position and could lead to improved reimbursement rates and market penetration, particularly in cost-sensitive healthcare environments. The pediatric safety data is especially valuable, as it addresses a important market segment where safety concerns often limit treatment options.
– Real World Study Compared Over 150,000 Adult & Pediatric Patients –
– Caldolor Associated with Fewer Adverse Drug Reactions –
– Caldolor also Improved Healthcare Utilization –
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
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 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;
- 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 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. 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.
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SOURCE Cumberland Pharmaceuticals Inc.
FAQ
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