Covidien Launches Oral Transmucosal Fentanyl Citrate Product

Covidien Launches Oral Transmucosal Fentanyl Citrate Product
ST. LOUIS, Mar 03, 2010 (BUSINESS WIRE) -- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has 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.


Reports of serious adverse events, including deaths, in patients treated with oral transmucosal fentanyl citrate have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of oral transmucosal fentanyl citrate for any other fentanyl product may result in fatal overdose.

Oral transmucosal fentanyl citrate is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Oral transmucosal fentanyl citrate is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.

Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients.

Oral transmucosal fentanyl citrate is contraindicated in the management of acute or postoperative pain including headache/migraine.

When prescribing, do not convert patients on a mcg per mcg basis to oral transmucosal fentanyl citrate from other fentanyl products.

When dispensing, do not substitute an oral transmucosal fentanyl citrate prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of oral transmucosal fentanyl citrate compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of oral transmucosal fentanyl citrate for any other fentanyl product may result in fatal overdose.

Special care must be used when dosing oral transmucosal fentanyl citrate. If the breakthrough pain episode is not relieved 15 minutes after completion of the oral transmucosal fentanyl citrate unit, patients may take ONLY ONE additional dose using the same strength and then must wait at least 4 hours before taking another dose [see Dosage and Administration (2.2)].

Oral transmucosal fentanyl citrate contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Oral transmucosal fentanyl citrate can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oral transmucosal fentanyl citrate in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Patients and their caregivers must be instructed that oral transmucosal fentanyl citrate contains a medicine in an amount which can be fatal to a child. Death has been reported in children who have accidentally ingested oral transmucosal fentanyl citrate. All units must be kept out of the reach of children and opened units properly discarded [see Warnings and Precautions (5.3), Patient Counseling Information (17.5, 17.6), and How Supplied/Storage and Handling (16.2)].

Oral transmucosal fentanyl citrate is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

The concomitant use of oral transmucosal fentanyl citrate with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see Drug Interactions (7)].

For full prescribing information, call Covidien's Medical Information Department at 1-800-778-7898 or go to


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. Please visit to learn more about our business.

ACTIQ(R) is a registered trademark of Anesta Corporation.

Forward-Looking Statements

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.

1 Portenoy RK and Hagen NA, Pain, 1990; 41:273-281

SOURCE: Covidien

CovidienJoAnna Schooler, 314-654-3543Director, [email protected] Lannum, 508-452-4343CFAVice President, Investor [email protected] Gillespie, 314-654-3263Manager, Media [email protected] Nameth, 508-452-4363Director, Investor [email protected]