On Apr. 1, 2020, Cumberland Pharma announced a national initiative to support hospitals and clinics that use Caldolor (ibuprofen) injection for the treatment of patients with fever, severe hyperthermia and other symptoms associated with COVID-19 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.

Because of the potential dangers of a high fever, recent guidelines from the Society of Critical Care Medicine suggest that clinicians consider using pharmacologic agents for controlling fever in COIVD-19 patients. High core body temperatures exceeding 101.3°F are associated with an increased incidence of convulsions, especially in children. Delirium can occur with temperatures between 103.1°F and 104.0°F, and coma with temperatures above 107.6°F.

Eighty-eight percent of the patients in Wuhan, China infected with COVID-19 developed a fever during hospitalization. Of those patients, 26 percent were treated in an intensive care unit, and of those, approximately 60 percent developed respiratory failure and 31 percent developed shock.  Prolonged hospital stays for those patients were not uncommon.

Some patients with high fevers are unable to swallow or retain oral antipyretic drugs and retain rectal suppositories. Caldolor offers these patients relief and it is the only injectable nonsteroidal anti-inflammatory drug (NSAID) approved for the treatment of fever in the United States. Caldolor was first approved in 2009 for the reduction of fever in adults and children 6 months and older, as well as pain management or those age groups. The safety and effectiveness of  IV ibuprofen has been investigated in 10 pre- and post-approval clinical studies involving nearly 2,000 subjects, resulting in a wealth of published clinical data and an outstanding safety database.

Furthermore, the definitive study of injectable ibuprofen for the treatment of fever – reported in the New England Journal of Medicine ­– found significant fever reduction, overall favorable outcome trends and no safety concerns in 455 patients. The double-blind, placebo-controlled trial evaluated large doses of injectable ibuprofen administered every six hours for up to 44 hours, and patients monitored for up to 30 days. The World Health Organization has also recently issued new guidance that states there is no published or peer-reviewed data suggesting that use of ibuprofen leads to a worsening of COVID-19.

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.