BioDelivery Sciences International announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a new formulation for Onsolis (fentanyl buccal soluble film) for the management of breakthrough pain in opioid-tolerant patients with cancer.
The new formulation includes appearance-related changes that were announced earlier. BioDelivery Sciences also announced the marketing authorization for the United States will be returned to them from their partner Meda Pharmaceuticals.
Onsolis, a CII controlled substance, utilizes BioErodible MucoAdhesive (BEMA) drug delivery technology, where a small bioerodible polymer film is used to apply to the buccal mucosa. Onsolis will be a part of the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy to ensure risk-benefit decisions prior to treatment, and to ensure appropriate use of TIRF medicines during treatment.
The company anticipates the re-introduction of Onsolis to be sometime in 2016.
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