Market Name: Fentora

Generic Name: Fentanyl buccal

Fentora, an opioid agonist and a Schedule II controlled substance, has been approved by the FDA for the treatment of breakthrough cancer pain.

Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The concomitant use of Fentora with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.

A black box warning was added to Fentora’s prescribing information by the FDA in March of 2007.

Black Box Warning Date: March 2007

FDA Link: Fentora