Caldolor launched ahead of schedule in U.S. by Cumberland Pharmaceuticals

Sep 9 2009

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has successfully implemented the U.S. launch of Caldolor((R)), an intravenous formulation of ibuprofen, designed primarily for use in the hospital setting. Caldolor is the first and only injectable product available in the United States for the treatment of pain and fever. Cumberland received U.S. Food and Drug Administration marketing approval for Caldolor in June 2009. The product is now fully stocked at the wholesalers serving hospitals nationwide, and is available in both 400mg and 800mg vials.

"We are pleased to introduce Caldolor ahead of schedule, offering a new level of patient care as ibuprofen advances to IV," said A.J. Kazimi, Cumberland's Chief Executive Officer. "We have worked diligently over the past year to prepare for the introduction of Caldolor to physicians and patients as the only injectable product available in the United States for reduction of fever, and as an important alternative for single-agent and multi-modal pain management."

In preparation for the product launch, Cumberland conducted comprehensive market research, prepared a full package of educational materials, optimized hospital coverage and recently launched the product website. Caldolor will be supported by 113 experienced sales professionals across the country, comprised of Cumberland's recently expanded hospital sales force of 77 representatives and managers as well as its field sales force of 36 representatives and managers. Cumberland has also expanded its professional affairs group to handle medical inquiries about the product.

"The introduction of IV ibuprofen (Caldolor) should allow anesthesiologists to achieve improved pain control with less opioid analgesic medication, thereby improving patient satisfaction," said Dr. Paul F. White, Professor and holder of the McDermott Distinguished Chair of Anesthesiology & Pain Management at the University of Texas Southwestern Medical Center at Dallas and visiting scientist at Cedars Sinai Medical Center in Los Angeles. "The use of IV ibuprofen can help reduce opioid-related side effects, and Caldolor is the first IV analgesic with antipyretic and anti-inflammatory properties."

Until now, the only injectable drugs available to reduce pain were opioids, such as morphine and meperdine, and the non-steroidal anti-inflammatory drug ketorolac. Opioids can cause sedation, nausea, vomiting, cognitive impairment and respiratory depression, and ketorolac has been associated with side effects such as increased risk of bleeding as well as gastrointestinal and renal complications. Caldolor is the first new injectable product available in the United States in 20 years for IV pain treatment, and provides safe and effective relief from both pain and fever. Caldolor also offers reliable IV delivery of ibuprofen, which has a long history of safe and effective use as an oral formulation.

"We are greatly encouraged by the medical community's favorable early reception for Caldolor, particularly the rate at which hospitals are adding the product to their formularies," Mr. Kazimi added. "Moreover, with the imminent onset of the flu season, we envision Caldolor as becoming an important new treatment for high fever often seen in hospitalized flu patients."

Source: http://www.caldolor.com