FDA approves new Onsolis formulation

August 18, 2015

FDA has approved sNDA for new formulation of fentanyl buccal soluble film (Onsolis, BioDelivery Sciences International) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

FDA has approved sNDA for new formulation of fentanyl buccal soluble film (Onsolis, BioDelivery Sciences International) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

Related: FDA: Final guidance on evaluation, labeling of abuse-deterrent opioids

Onsolis contains fentanyl, an opioid agonist, in the form of a buccal soluble film. Onsolis utilizes the BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of 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 new formulation of Onsolis. The new formulation was submitted to FDA to address previously announced appearance-related changes.

Earlier this year, BioDelivery Sciences International (BDSI) announced that it entered into an assignment and revenue sharing agreement with its Onsolis partner, Meda Pharmaceuticals, to return the marketing authorization to BDSI to seek marketing authorizations for Onsolis in the United States, Canada, and Mexico.

Related:DEA issues alert on fentanyl after overdoses

“BioDelivery Sciences is bringing back to 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”.

Fentanyl is classified 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 misuse 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 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 therapy for their underlying cancer pain. Patients who are considered opioid tolerant are those who are taking at least 60-mg oral morphine per day or an equivalent analgesic dose of another opioid for 1 week or longer.

Some of the most common side effects associated with the use of Onsolis in clinical trials include nausea, vomiting, dehydration, asthenia, dyspenia, and fatigue. The most serious adverse reactions associated with the use of Onsolis, as with all opioids, are respiratory depression, circulatory depression, hypotension, and shock.

Onsolis is expected to return to the US market in 2016. 

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