Cumberland Pharmaceuticals Inc. operates as a specialty pharmaceutical company that focuses on the acquisition, development, and commercialization of branded prescription products. The company’s primary target markets are hospital acute care and gastroenterology. It markets and sells its approved products through its hospital and gastroenterology sales forces in the United States and is establishing a network of international partners to bring its products to patients in their countries. Product Portfolio Acetadote Acetadote is an intravenous formulation of N-acetylcysteine, or (NAC), indicated for the treatment of acetaminophen poisoning. Acetadote, has been available in the United States since Cumberland's 2004 introduction of the product through its hospital sales force. Acetadote is typically used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in various over-the-counter and prescription pain relieving and fever-reducing products. Caldolor Caldolor, the company's intravenous formulation of ibuprofen, was the first injectable product approved in the United States for the treatment of both pain and fever. The company conducted a series of clinical studies in approximately 900 adult patients to develop the data to support its submission for U.S. Food and Drug Administration (FDA) approval. The FDA approved Caldolor for marketing in the United States during the middle portion of 2009 following a priority review. The product is indicated for use by adults and pediatric patients six 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. At December 31, 2015, Caldolor has been purchased by approximately 1,300 health care facilities in the United States. Kristalose 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 improve patient compliance and acceptance. Kristalose is the prescription laxative available in pre-measured powder packets. Kristalose dissolves in four ounces of water, offering patients a virtually taste-free, grit-free and calorie-free alternative to lactulose syrups. Omeclamox-Pak The company launched its promotion and distribution efforts to support Omeclamox-Pak in early 2014. Its field sales force promotes Omeclamox-Pak to the gastroenterologist segment, which accounts for the largest component of the prescriber base for this product. Omeclamox-Pak is a branded prescription product used for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease. This product combines three widely prescribed medications, including omeprazole, clarithromycin, and amoxicillin. Omeclamox-Pak is the first FDA approved triple therapy combination medication to contain omeprazole as the proton pump inhibitor, which works to decrease the amount of acid the stomach produces. Clarithromycin and amoxicillin are both antibiotic agents which hinder the growth of H. pylori. Vaprisol The company has an agreement with Astellas Pharma US, Inc. (Astellas) to acquire Vaprisol, including certain product rights, intellectual property and related assets. Vaprisol is a patented, prescription brand indicated to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia. It is one of two branded prescription products indicated for the treatment of hyponatremia, and the intravenously administered branded treatment. Vaprisol raises serum sodium to appropriate levels and promotes free water secretion. Hepatoren The company has an agreement to acquire the rights to ifetroban, a new Phase II product candidate. Its acquisition of the rights to the ifetroban program includes an extensive clinical database and non-clinical data package as well as manufacturing processes, know-how and intellectual property. Ifetroban was initially developed by a large pharmaceutical company for significant cardiovascu
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