Cumberland Pharmaceuticals Launches Initiatives to Expand Access to Product Lines in Treating COVID-19

Apr 08, 2020 at 01:01 pm by Staff

Over the last two weeks, Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) a specialty pharmaceutical company, has announced several national initiatives to support hospitals and clinics using their products to treat symptoms and concurrent issues tied to the novel coronavirus.

The Nashville-based company first announced the expansion of VIBATIV® availability, which is used to treat patients with hospital-acquired and ventilator-associated pneumonia that can be a byproduct of COVID-19 for hospitalized patients. Cumberland's initiative includes the availability of special financial arrangements for hospitals and clinics to help ensure supply during the pandemic. In addition, Cumberland announced sponsorship of a national program with infectious disease experts to provide information on the management of complicated respiratory infections resulting from the novel coronavirus.

Since then, the company launched a similar initiative around Caldolor® (ibuprofen) injection for the treatment of patients with fever, severe hyperthermia and other symptoms associated with COVID-19 infections. Cumberland has increased supply and created financial arrangements, including favorable pricing and payment terms for hospitals and clinics to help ensure timely access to Caldolor during this healthcare crisis.

"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 A.J. Kazimi, CEOof Cumberland Pharmaceuticals.

Although initial, anecdotal information from some providers in France and the World Health Organization (WHO) discouraged use of NSAIDS in favor of acetaminophen, the WHO has now walked back some of those comments. According to Cumberland, 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.6 WHO 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-19.1

Because of the potential dangers of a high fever, however, recent guidelines from the Society of Critical Care Medicine suggest that clinicians consider using pharmacologic agents for controlling fever in COIVD-19 patients.2 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.3

Most recently, the company announced expansion of Vaprisol® (conivaptan hydrochloride) injection for treating hyponatremia, associated with critical care patients during the COVID-19 pandemic. Vaprisol is an FDA approved treatment for hyponatremia, a potentially life-threatening condition that can often afflict patients in the Intensive Care Unit ("ICU").

Hyponatremia frequently occurs when the concentration of sodium in a patient's blood is abnormally low, which can lead to neurologic dysfunction, decreased mental function and cerebral edema, among other complications. The condition is particularly prevalent among ICU patients. On average, over 30 percent of patients admitted to an ICU have hyponatremia4 and another 18 percent develop the condition during their ICU stay.5 Several studies have shown that patients with hyponatremia spend a longer time in the ICU, spend more time on mechanical ventilators and have increased mortality while in the ICU.6 Vaprisol can help address hyponatremia in the first 24 hours.7

"It is our hope that this enhanced access to Vaprisol will help lead to shorter ICU stays and thereby free-up potentially life-saving ICU beds that could become in short supply during the COVID-19 pandemic," said Kazimi.

For more information regarding special access and financing arrangements for any of these products, contact Jim Herman, Cumberland's senior vice president of national accounts at jherman@cumberlandpharma.com.

References:

  1. World Health Organization (WHO) Guidelines on use of ibuprofen in treating symptoms associated with COVID-19 patients. Accessed March 29, 2020.
  2. 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.
  3. 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 America and the American Thoracic Society. Clin Infect Dis.2016;63(5):e61-111.
  4. Padni R, Panda BN, Jagati S, et al. Hyponatremia in critically ill patients. Indian J Crit Care Med. 2014; 18(2):83-7.
  5. Mahmoud MI, Khalil OA, Afifi WM, et al. Epidemiology and clinical outcome of ICU-acquired dysnatremia in critically ill medical patients, a single center study. Life Sci J. 2013;10(2): 415-20.
  6. Callahan MA, Do HT, Caplan DW, et al. Economic impact of hyponatremia in hospitalized patients: a retrospective cohort study. Postgrad Med. 2009;12(2):186-91
  7. Vaprisol prescribing Information. Cumberland Pharmaceuticals Inc. 2017.
Sections: COVID