A Supplemental New Drug Application (sNDA) for a novel formulation of the drug Onsolis (fentanyl buccal soluble film), has been approved by the FDA. Onsolis is manufactured by BioDelivery Sciences International (BDSI), and is used to treat breakthrough pain in cancer patients who are tolerant to opioids.
The sNDA was submitted to the FDA after the reformulation of the pharmaceutical. The drug is administered to the inner lining of the cheek where the BioErodible MucoAdhesive (BEMA) technology allows the polymer film to dissolve inside the mouth. Fentanyl, an opioid agonist, is the active ingredient in Onsolis.
To prevent abuse and overdose of fentanyl – a Schedule II controlled substance – the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigations Strategy (REMS) program is the only available way to prescribe Onsolis. The FDA requires that before patients receive treatment with Onsolis, they understand the associated risks and benefits and are able to make an informed decision.
Earlier this year, marketing authorization for Onsolis was returned to BDSI from its revenue-sharing partner in the drug, Media Pharmaceuticals. The company pursued marketing authorization for the drug in the US, Canada and Mexico.
“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 for 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.”
Onsolis can only be prescribed to patients 18 years and older who experience breakthrough pain associated with cancer. These patients must be receiving at least 60 mg of oral morphine per day – or an equivalent dose of another opioid – and continuing to experience breakthrough pain, indicating opioid tolerance.
Clinical trials of Onsolis identified the most common side effects of the drug which include nausea, vomiting, dehydration, asthenia, dyspnea, and fatigue. As with all opioids, the most serious reactions associated with Onsolis include respiratory depression, circulatory depression, hypotension, and shock.
- FDA approves new Onsolis formulation – http://formularyjournal.modernmedicine.com/formulary-journal/news/fda-approves-new-onsolis-formulation