.gif)
focus in the areas of pain management and addiction medicine, announced the approval by the US Food and Drug Administration (FDA) of a Supplemental New Drug Application (sNDA) for a new formulation of Onsolis (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. Onsolis is separately licensed by BDSI in Taiwan and South Korea.
"We are pleased to have obtained FDA approval of our sNDA and to now be in a position to move toward returning Onsolis to the U.S. marketplace," said Dr. Mark A Sirgo, president and chief executive officer. "Onsolis 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."
Onsolis will be part of the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) programme, which is an FDA-required programme designed to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines.
The purpose of the TIRF REMS Access program is to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.
Subscribe to PharmaTutor News Alerts by Email >>
