Cumberland Pharmaceuticals Announces Initiative to Expand Availability of Caldolor® to Help Treat High Fevers Associated With Coronavirus Infections
Cumberland's initiative includes the availability of special supply and financial arrangements, including favorable pricing and payment terms for hospitals and clinics to help ensure timely access to Caldolor during this healthcare crisis. For more information regarding this special access, contact
"Reducing a very high fever can be particularly important in certain patients infected by COVID-19 and we are removing logistical and financial obstacles that might stand in the way of quickly getting health care providers a very effective, fast-acting and safe fever-reducing drug. We stand ready to take further actions required to assure that medical providers have access to an uninterrupted supply of this critical medication," said
Because of the potential dangers of a high fever, recent guidelines from the
Eighty-eight percent of the patients in
Some patients with high fevers are unable to swallow or retain oral antipyretic drugs and retain rectal suppositories.5 Caldolor offers these patients relief and it is the only injectable nonsteroidal anti-inflammatory drug (NSAID) approved for the treatment of fever in
Furthermore, the definitive study of injectable ibuprofen for the treatment of fever – reported in the
Cumberland has also completed a multicenter study of Caldolor in newborns from birth to 6 months of age. Topline results from this newborn study indicated that the pharmacokinetics of the drug are similar to those in older children and adults, while no safety concerns were noted. This comes after the Company conducted clinical trials and received FDA approval in 2015 for children aged 6 months to 17 years old.
For more information on Caldolor, including important dosing and safety instructions, please see the product website and package insert at www.caldolor.com.
- Morens DM, Taubenberger JK, Fauci AS. Predominant role of bacterial pneumonia as a cause of death in pandemic influenza: implications for pandemic influenza preparedness. J Infect Dis. 2008;198(7):962–970.
- Kalil AC, Metersky ML, Klompas M, et al. Management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the
Infectious Diseases Society of Americaand the American Thoracic Society. Clin Infect Dis. 2016;63(5):e61–111.
- Zhou F, Ting Y, Roughui D, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in
Wuhan, China: a retrospective cohort study. The Lancet. March 11, 2020; DOI: https://doi.org/10.1016/S0140-6736(20)30566-3.
- World Health Organization Situation Report from
March 3, 2020.
- Morris P, Promes JT, Guntupalli KK, et al. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Critical Care. 2010; 14R125.
- Bernard GR, Wheeler AP, Russell JA, et al. The Effects of Ibuprofen on Physiology and Survival of Patients with Sepsis. NEJM. 1997; 336:912-918.
World Health Organization(WHO) Guidelines on use of ibuprofen in treating symptoms associated with COVID-19 patients. Accessed March 29, 2020.
Caldolor is indicated in adults and pediatric patients 6 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. 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 G.I. 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.
- 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;
- Vaprisol® (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
- 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;
- RediTrex™ (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.
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 a series of 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 ("P.H.").
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
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Investor Contact: Erin Gull, Corporate Relations, (615) 255-0068 or Media Contact: Jeff Bradford, the Bradford Group, (615) 515-4880