United States

Profile: Cumberland Pharmaceuticals Inc (CPIX.O)

CPIX.O on Nasdaq

14 Jun 2019
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Cumberland Pharmaceuticals Inc. (Cumberland), incorporated on January 7, 1999, is a specialty pharmaceutical company. The Company is focused on the acquisition, development and commercialization of branded prescription products. The Company operates through specialty pharmaceutical products segment. Its target markets are hospital acute care and gastroenterology. The Company markets and sells its approved products through its hospital and gastroenterology sales forces in the United States. The Company's product portfolio includes Acetadote (acetylcysteine) Injection; Caldolor (ibuprofen) Injection; Kristalose (lactulose) for Oral Solution; Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin); Vaprisol (conivaptan) Injection; Hepatoren (ifetroban) Injection, and Boxaban (ifetroban) oral capsules.


Acetadote is an intravenous formulation of N-acetylcysteine (NAC), indicated for the treatment of acetaminophen poisoning. Acetadote is available in the United States through the Company's hospital sales force. Acetadote is used in hospital emergency departments to prevent or lessen liver damage resulting from an overdose of acetaminophen. Acetadote received the United States Food and Drug Administration (FDA) approval as an orphan drug.


Caldolor is the Company's intravenous formulation of ibuprofen, which is an injectable product approved in the United States for the treatment of both pain and fever. The Company conducted a series of clinical studies in over 900 adult patients to develop the data to support its submission for FDA approval. The FDA approved Caldolor for marketing in the United States. The product is indicated for use in adults and pediatric patients for the management of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics, as well as for the reduction of fever.


Kristalose is a prescription laxative administered orally for the treatment of acute and chronic constipation. A dry powder crystalline formulation of lactulose, Kristalose is designed to enhance patient compliance and acceptance. Kristalose is a laxative available in pre-measured powder packets.


Omeclamox-Pak is a branded prescription product used for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease. This product combines approximately three prescribed medications: omeprazole, clarithromycin and amoxicillin. Omeclamox-Pak is an FDA approved triple therapy combination medication to contain omeprazole as the proton pump inhibitor. Clarithromycin and amoxicillin are both antibiotic agents, which hinder the growth of H. pylori.


Vaprisol is a prescription brand indicated to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia. It is indicated for the treatment of hyponatremia, and the only intravenously administered branded treatment. Vaprisol raises serum sodium to appropriate levels and promotes free water secretion.


The Company initiated clinical development under the brand name Hepatoren (ifetroban) Injection and is evaluating this candidate for the treatment of critically ill hospitalized patients suffering from hepatorenal syndrome (HRS). HRS is a life threatening condition involving progressive kidney failure.


The Company initiated clinical development under the brand name Boxaban (ifetroban) capsules and is evaluating this candidate for patients suffering from aspirin-exacerbated respiratory disease (AERD). AERD is a respiratory disease involving chronic asthma and nasal polyposis that is worsened by aspirin or nonsteroidal anti-inflammatory drugs.

The Company competes with Geneva Pharmaceuticals, Inc., Ben Venue Laboratories, Inc., Roxane Laboratories, Inc., InnoPharma Inc., Hospira Inc, Paddock Laboratories, LLC, Perrigo Company, Mallinckrodt plc, Pacira Pharmaceuticals, Inc., Sucampo Pharmaceuticals Inc., Takeda Pharmaceutical Company Limited, Actavis Pharma, Inc., Forest Laboratories, Inc., Prometheus Therapeutics and Otsuka Pharmaceutical Company.

Company Address

Cumberland Pharmaceuticals Inc

2525 W End Ave Ste 950
NASHVILLE   TN   37203-1608
P: +1615.2550068
F: +1615.2550094

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