Cumberland Pharmaceuticals Announces The National Launch Of A New Caldolor Ready-To-Use Product
A non-steroidal anti-inflammatory drug (NSAID), Caldolor may be used as the sole method of treatment for mild-moderate pain or as part of a multi-modal treatment for severe pain. Thus it is positioned to play an important role in combatting the nation's opioid crisis, which claims the lives of over 130 Americans a day, according to
Even short-term opioid use after surgery can lead to long-term addiction. Prompt and appropriate pain management is vital to mitigating opioid use. Published data for Caldolor supports administration just prior to surgery and throughout the postoperative period. As a result patients experience significantly less pain upon awakening, then remain in significantly less pain, while also reducing their opioid consumption.
"We have been encouraged by the significant number of physicians who have incorporated Caldolor into their pain management regimens as a way to combat the negative effects of opioid use," said
Caldolor possesses three key therapeutic properties: anti-inflammatory, analgesic and antipyretic action. Uncontrolled inflammation may contribute to hypersensitivity to pain and lead to chronic post-operative pain. Pre-empting this response with Caldolor may reduce the need for continued post-operative opioids and improve recovery through reduction in opioid-related side effects, such as nausea, vomiting and constipation.
The new formulation of Caldolor comes in a pre-mixed bag containing 800 mg of ibuprofen in a 200 mL patented low sodium formulation for injection that is ready to use. It is the first and only
Prudent and careful management of pain is among the most important responsibilities of every healthcare provider. New strategies are emerging to control acute and chronic pain in the hospital setting, and Cumberland has provided grants in support of educational webinars in partnership with two of the nation's leading physician services companies. Through these initiatives, three webinars have been developed that introduce healthcare providers to new therapies and pain modalities for more effective pain management. These accredited webinars recognize that many patients are first introduced to opioids in a hospital or surgery center setting and, in some cases, may become dependent upon or even abuse their opioid treatments. This cycle can be avoided through the introduction of non-opioid medications like Caldolor which can serve as the basis for multimodal strategies to improve pain management.
There is a growing body of published evidence showing that Caldolor can significantly decrease both surgical pain and opioid use. One clinical study, conducted at
Another study, conducted at
Cumberland has recently completed a clinical study for the use of Caldolor in patients from birth to 6 months of age. This comes after the Company conducted clinical trials and received
Caldolor can be a key component in cost effective Enhanced Recovery After Surgery (ERAS) multimodal treatment protocols. Clinical studies of Caldolor demonstrate:
- Up to a 58% reduction in opioid use compared to placebo group1
- Up to a 43% reduction in VAS scores at rest compared to opioids alone2
- Patients reporting significantly less pain shortly after waking3
- Patients remain in significantly less pain during recovery3
- Potential to improve quality of recovery and reduce postsurgical fatigue4
- Significant pain and fever reduction in children ages six months and older5
Caldolor is indicated in adults and pediatric patients six months and older 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 should be noted that 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. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, including boxed warning, visit www.caldolor.com.
- Shephard DM, Jahnke H, White WL, et al. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery. J Neurosurg 2018; 128(2): 444-451.
- Moss. JR, Watcha MF,
Bendel LP, et al. A multicentre, randomized, double-blind placebo-controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy. Pediatric Anesthesia 2014; 24(5): 483-498.
- Singla N, Rock A, and Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopaedic adult patients. Pain Med 2010; 11(8): 1284-1293.
- Le V, Kurnutala L, Schianodicola J, et al. Premedication with intravenous ibuprofen improves recovery characteristics and stress response in adults undergoing laparoscopic cholecystectomy: a randomized controlled trial. Pain Med 2016; 17(6): 1163-1173.
- CALDOLOR [Package Insert]
Nashville, TN: Cumberland Pharmaceuticals Inc.2019.
- Acetadote® (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection, for the treatment of pain and fever;
- Kristalose® (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation;
- Omeclamox®-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
- RediTrex™ (methotrexate) Injection, for the treatment of adult and pediatric patients with rheumatoid arthritis and adults with psoriasis;
- 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.
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 www.cumberlandpharma.com.
The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD"), Hepatorenal Syndrome ("HRS") and Portal Hypertension ("PH").
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 our intent, belief or expectations. 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 and other factors discussed in the Company's most recent Form 10-K and subsequent 10-Q's as filed with the
View original content to download multimedia:http://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-announces-the-national-launch-of-a-new-caldolor-ready-to-use-product-300982929.html
Investor Contact: Erin Gull, Corporate Relations, (615) 255-0068; Media Contact: Jeff Bradford, the Bradford Group, (615) 515-4880