Xtampza ER is Collegium’s first product utilizing its proprietary DETERx® technology platform, and is designed to provide adequate pain control while maintaining its extended-release drug release profile after being subjected to common methods of abuse and accidental misuse. While abuse of Xtampza ER is still possible, FDA has determined that the product has abuse-deterrent properties. The Xtampza ER label supports alternate administration options, including, sprinkling the capsule contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.
Collegium also owns the U.S. rights to ONSOLIS® (fentanyl buccal soluble film). ONSOLIS is a Transmucosal Immediate-Release Fentanyl (TIRF) film indicated for the management of breakthrough pain in cancer patients (BTPc), 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS incorporates BioDelivery Sciences’ BioErodible MucoAdhesive (BEMA®) technology for rapid and controlled delivery of fentanyl, a Schedule II controlled substance, via buccal (inner cheek) administration.
ONSOLIS was originally approved by the U.S. Food and Drug Administration (FDA) in 2009 and voluntarily removed from the market in 2011 to address appearance-related issues. A reformulation of ONSOLIS was approved by the FDA in 2015. Collegium expects to launch the product after the completion of the transfer of manufacturing and submission to the FDA of a Prior Approval Supplement, which requires approval prior to launch. It is currently estimated that approval will occur in mid-2017.