New AcetadoteÂ® Formulation Now Available in the U.S.
NASHVILLE, Tenn., March 22, 2011 /PRNewswire/ — Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that it has completed the U.S. launch of its new formulation of AcetadoteÂ® (acetylcysteine) Injection, the Company’s product used to treat acetaminophen poisoning. The proprietary new formulation, which does not contain ethylene diamine tetracetic acid (EDTA) or any other stabilization or chelating agents, is now stocked at wholesalers serving hospitals across the country.
Acetadote is used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products. The new formulation was approved by the U.S. Food and Drug Administration (FDA) in January and replaces the previously marketed product. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States(1), and Acetadote has become a standard of care for treating this potentially life-threatening condition.
“We are pleased to make this next generation of Acetadote available to the hospital community and the growing number of patients who will benefit from it,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “This launch marks an important milestone in our strategy to support our products by improving upon existing formulations and expanding into new patient populations.”
Cumberland has worked with U.S. wholesalers to transition inventories from the original to the new formulation. Shipments of the original formulation have ceased and the Company is now filling all Acetadote orders with the new product. A communications campaign has been initiated to support poison control centers and U.S. hospital pharmacists as they transition to the new formulation, which includes an extended shelf life of 30 months, up from 24 months for the original formulation. Cumberland is currently working with the U.S. Patent and Trademark Office to protect the proprietary nature of the new formulation.
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. For full prescribing information, visit www.acetadote.net.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company’s primary target markets include hospital acute care and gastroenterology. Cumberland’s product portfolio includes AcetadoteÂ® (acetylcysteine) Injection for the treatment of acetaminophen poisoning; CaldolorÂ® (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States; and KristaloseÂ® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information, please visit the company website at www.cumberlandpharma.com.
Important Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that reflect Cumberland’s current views with respect to 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 operations are subject to influences outside of the Company’s control. Risk factors that could materially affect results of operations include, among other things, market conditions, intense competition from existing and new products, an inability of manufacturers to produce Acetadote on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to drug manufacturers, maintaining and building an effective sales and marketing infrastructure, government regulation, the possibility that patent rights may provide only limited protection from competition, and other factors related to the Company including those under the headings “Risk factors” and “Management’s discussion and analysis of financial condition and results of operations” in Cumberland’s Form 10-K filed with the SEC on March 11, 2011. There can be no assurance that the results or developments anticipated by Cumberland will be realized or, if realized, 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. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof.
(1) National Poison Data System, American Association of Poison Control Centers
SOURCE Cumberland Pharmaceuticals Inc.