An FDA-approved oral transmucosal fentanyl citrate, an opioid analgesic for cancer pain management, is being launched by Mallinckrodt Inc., a Covidien company.
An FDA-approved, oral transmucosal fentanyl citrate and opioid analgesic (Mallinckrodt Inc., a Covidien company) for cancer pain management, is being launched. FDA cleared the Abbreviated New Drug Application (ANDA) for the generic substance in October 2009.
The product is an alternative to branded Actiq. The drug is a solid fentanyl formulation that looks like a lozenge on a handle. The class II controlled substance is indicated for the management of breakthrough cancer pain in those 16 years of age and older with malignancies. Patients need be able to handle around-the-clock opioid therapy for persistent cancer pain prior to taking the oral agent.
Oral transmucosal fentanyl citrate will come in 200 µg, 400 µg, 600 µg, 800 mcg, 1,200 µg, and 1,600 µg strengths.