Covidien, a leading global provider of healthcare products, announced that Mallinckrodt Inc., a Covidien company, launched its Oral Transmucosal Fentanyl Citrate (CII) to distributors serving retail pharmacies across the country. The U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII) on October 30, 2009. The product is expected to be available at retail pharmacies in the next few weeks.
The product is a generic alternative to the branded ACTIQ(R). It is a solid formulation of fentanyl that resembles a lozenge on a handle. Oral Transmucosal Fentanyl Citrate, a Class II controlled substance, is an opioid analgesic indicated only for the management of breakthrough cancer pain in patients 16 years of age and older with malignancies. These patients must already be receiving and be tolerant to around-the-clock opioid therapy for their underlying, persistent cancer pain.
Studies suggest that as many as two-thirds of patients with chronic cancer-related pain, who are receiving around-the-clock opioid analgesic pain medications, still experience intermittent flares of pain that literally break through their regular pain medication1.
"According to the National Institutes of Health, pain by itself is a serious health issue for these patients, separate and apart from their underlying cancer," said Herbert Neuman, M.D., Vice President and Chief Medical Officer, Pharmaceuticals, Covidien. "This generic product will be an effective option to the branded product for patients suffering from breakthrough pain."
Covidien's launch of Oral Transmucosal Fentanyl Citrate in the U.S. includes 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,200 mcg and 1,600 mcg strengths. The Company has implemented an extensive risk management plan to help ensure the appropriate and safe use of this medication.
"We continue to build on our extensive pain treatment experience by enhancing patient access to advanced medications for managing pain," said Timothy R. Wright, President, Pharmaceuticals, Covidien.
Covidien is the largest supplier of controlled pain medications in the United States based on the number of prescriptions. The Company has more than 100 years of experience in responsibly manufacturing and distributing pain medications.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. For more information, visit www.covidien.com .