To Help Prepare for the COVID-19 Patient Surge Cumberland Pharmaceuticals Expands Availability of Vaprisol® to Treat Hyponatremia in Critical Care Units

- Vaprisol® safely and effectively addresses hyponatremia in the first 24 hours

- Over 30% of patients admitted to the ICU have hyponatremia and another 18% develop it while in the ICU

- Hyponatremia has been found to increase length of stay, mechanical ventilator days and mortality

NASHVILLE, Tenn., April 7, 2020 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) a specialty pharmaceutical company, today announced an initiative to increase availability 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").

Cumberland Pharmaceuticals Logo (PRNewsFoto/Cumberland Pharmaceuticals Inc.)

Cumberland's initiative includes special supply and financial arrangements, including favorable pricing and payment terms, for hospitals and clinics to help ensure timely access to Vaprisol during this healthcare crisis. For more information regarding this special access, contact Jim Herman, Cumberland's Senior Vice President National Accounts at jherman@cumberlandpharma.com.

"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 A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals Inc.

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 hyponatremia1 and another 18 percent develop the condition during their ICU stay2. 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 ICU3. Vaprisol can help address hyponatremia in the first 24 hours4.

For more information on Vaprisol, including important dosing and safety instructions, please see the product website and package insert at www.vaprisol.com.

References:

  1. Padni R, Panda BN, Jagati S, et al. Hyponatremia in critically ill patients. Indian J Crit Care Med. 2014; 18(2):83-7.
  2. 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.
  3. 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
  4. Vaprisol prescribing Information. Cumberland Pharmaceuticals Inc. 2017.

About Vaprisol®

Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure, and pneumonia. Vaprisol is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol was approved by the U.S. Food and Drug Administration in 2005 for euvolemic hyponatremia and in 2007 for hypervolemic hyponatremia. For full prescribing information visit www.vaprisol.com.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high-quality prescription brands to improve patient care. The Company develops, acquires, and commercializes brands for the hospital acute care and gastroenterology market segments. 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) 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.").

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.