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FDA has approved a new formulation of fentanyl buccal soluble film (Onsolis, BioDelivery Sciences International) CII for the management of breakthrough pain in cancer patients who are opioid-tolerant.
Onsolis has fentanyl, an opioid agonist, in the form of a buccal soluble film. Onsolis uses the BioErodible MucoAdhesive (BEMA) drug delivery technology, which comprises a small, bioerodible polymer film for application to the inner lining of the cheek. FDA has now approved a Supplemental New Drug Application (sNDA) for a novel formulation of Onsolis. The new formulation was submitted to FDA to address earlier announced appearance-related changes.
Earlier this year, BioDelivery Sciences International (BDSI) announced that it entered into an assignment and revenue sharing contract with its Onsolis partner, Meda Pharmaceuticals, to return the marketing authorization to BDSI to seek marketing authorizations for Onsolis in America, Canada, and Mexico.
“BioDelivery Sciences is bringing back to the market a novel product for the treatment of breakthrough cancer pain in opioid-tolerant patients using the company’s buccal film technology, BioErodible MucoAdhesive (BEMA),” said Al Medwar, vice president, marketing and corporate development, BioDelivery Sciences International, Inc. “Onsolis is the only product that allows for simple administration by placing the film on the inside of the cheek where it adheres and subsequently dissolves.”
Abuse and Risk of Fentanyl
Fentanyl is categorized as a Schedule II controlled substance, which means it has the highest potential for abuse and risk of fatal overdose due to respiratory depression. Because of the risk for abuse and addiction, Onsolis is only available through the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigations Strategy (REMS) program. This program is required by the FDA to ensure informed risk-benefit decisions before initiating treatment.
Onsolis is indicated only for the management of breakthrough pain in patients with cancer, who are aged 18 years and older, who are already receiving and who are tolerant to opioid treatment for their underlying cancer pain. Patients who are regarded as opioid-tolerant are those who are taking at least 60-mg oral morphine per day or an equivalent analgesic dose of another opioid for one week or longer.
Some of the most common side effects associated with the use of Onsolis in clinical trials consist of nausea, vomiting, dehydration, asthenia, dyspnea, and fatigue. The most severe adverse reactions associated with the use of Onsolis, as with all opioids, are respiratory depression, circulatory depression, hypotension, and shock.
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