FDA Approves New Option for Pain Management in Cancer Patients

Onsolis provides opioid tolerant patients with an alternative dosing option.

The FDA today approved a Supplemental New Drug Application (sNDA) for a new formulation of fentanyl buccal soluble film (Onsolis CII) for pain management in cancer patients who are opioid tolerant.

BioDelivery Sciences International (BDSI) announced earlier this year that it entered into an assignment and revenue sharing agreement with Meda Pharmaceuticals. The deal returns marketing authorization for the drug back to BDSI with the right to seek marketing authorizations for Onsolis in the United States, Canada, and Mexico.

“We are pleased to have obtained FDA approval of our sNDA and to now be in apposition to move toward returning Onsolis to the US marketplace,” said Mark A. Sirgo, PharmD, president and chief executive officer of BDSI. “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.”

While BDSI offers options for Onsolis, the current plan is to determine the value they can secure in a partnership with Meda Pharmaceuticals, who has access to the target physician audience, according to Dr. Sirgo.

Onsolis will be part of the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program, an FDA-required program designed to ensure informed risk-benefit decisions before initiating treatment, and to ensure appropriate use of TIRF medications while patients are treated.