New Fentanyl Mouth Patch Available for Use

By Michele Wallace

Published on October 13, 2009

BioDelivery Sciences International Inc. recently received U.S. Food and Drug Administration (FDA) approval for Onsolis, a fentanyl buccal soluble film. The company began selling the fentanyl mouth patches this week through Meda Pharmaceuticals, its commercial partner.

The fentanyl mouth patches manage pain in cancer patients 18 years of age or older who are opioid tolerant. The product releases fentanyl through a dissolvable, polymer film that sticks to the inside of the cheek.

Meda's national sales campaign targets pain management physicians, oncologists, and other health-care professionals who treat cancer pain.

Fentanyl skin patches such as Duragesic, Actiq, Fentora, and Sublimaze are already approved to treat chronic pain. However, misuse, abuse, and alleged leaks of the patches have led to severe scrutiny over the safety of these products.

Fentanyl side effects include diarrhea, nausea, constipation, dry mouth, confusion, abdominal pain, headache, fatigue, anorexia and weight loss, dizziness, nervousness, hallucinations, anxiety, depression, flu-like symptoms, sweating, hypoventilation, apnea, aphasia and altered mental states. The use of fentanyl with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and has been found to cause potentially fatal respiratory depression. Extreme use of fentanyl may cause overdose, which results in death.

Comment on this article →