Covidien Receives FDA Approval for Oral Transmucosal Fentanyl Citrate Product

• Press Release
• Source: Covidien
• On 4:03 pm EDT, Friday October 30, 2009

ST. LOUIS--(BUSINESS WIRE)--Covidien (NYSE: COV - News), a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

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Covidien’s product is a generic alternative to the branded ACTIQ^®. 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 who are already receiving and who are tolerant to opioid therapy for their underlying, persistent cancer pain.

“Pain is one of the most common reasons patients consult a physician, yet it is often inadequately treated,” said Herbert Neuman, M.D., Chief Medical Officer, Pharmaceuticals, Covidien. “We are pleased to receive this FDA approval and to introduce this treatment option to meet patients’ needs.”

Covidien expects to launch Oral Transmucosal Fentanyl Citrate in the U.S. in early calendar 2010, in 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,200 mcg and 1,600 mcg strengths. The launch will be accompanied by an extensive risk management plan to help ensure the appropriate and safe use of this medication.

“Covidien continues to build on its extensive pain treatment experience by focusing on providing patients with access to advanced medications,” said Timothy R. Wright, President, Pharmaceuticals, Covidien.

Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

ABOUT ORAL TRANSMUCOSAL FENTANYL CITRATE

WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION and POTENTIAL FOR ABUSE

Oral Transmucosal Fentanyl Citrate (OTFC) contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. OTFC can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OTFC 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.

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

OTFC 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.

Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates, OTFC is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients.

Patients and their caregivers must be instructed that OTFC contains a medicine in an amount which can be fatal to a child. All units must be kept out of the reach of children and opened units properly discarded.

The concomitant use of OTFC with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.

ABOUT COVIDIEN

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 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

ACTIQ 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, issues related to our existing material weakness in accounting for income taxes 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.

Covidien
JoAnna Schooler, 314-654-3543
Director, Communications
joanna.schooler@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President, Investor Relations
cole.lannum@covidien.com
or
Erica Abbett, 314-654-3247
Manager, Media Relations
erica.abbett@covidien.com
or
Brian Nameth, 508-452-4363
Director, Investor Relations
brian.nameth@covidien.com