Covidien Receives FDA Approval For Oral Transmucosal Fentanyl Citrate Product

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics
Article Date: 02 Nov 2009 - 4:00 PST

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Covidien (NYSE: COV), a leading global provider of healthcare products, 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).

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

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.

Source
Covidien