New Formulation of Fentanyl Citrate has been Approved by FDA for Breakthrough Cancer Pain
A new formulation of Fentanyl Citrate has been approved by FDA as a Supplemental New Drug Application (sNDA). Fentanyl Citrate is advised for the breakthrough pain management in opioid-tolerant cancer patients older than 18 years of age, who must currently be receiving opioid therapy for cancer pain.
These patients are considered opioid tolerant if they are taking a minimum 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day or an equianalgesic dose of another opioid for one week or longer.
Fentanyl Citrate remains an important differentiated fentanyl-containing product for this indication given that it is the only product for buccal administration, providing patients with an alternative dosing option.
This new formulation contains fentanyl in a small film that sticks inside the cheek and dissolves within 15-30 minutes. The patients should wait for minimum of 2 hours before taking another dose if breakthrough pain has not been resolved with the starting dose of 200-mcg Onsolis. Some common side-effects include respiratory depression, hypotension, shock, nausea, vomiting, dehydration and dizziness and it is contraindicated in managing acute or postoperative pain and for patients with known fentanyl intolerance. However, the drug will further be a part of the FDA-required Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy program.