Cephalon Applying Drug Delivery Expertise Toward Development of Tamper-Deterrent Formulation of Extended-Release Opioids
Prescription opioid medications are integral to the treatment of serious pain conditions. Both extended-release (long-acting) and immediate-release (short acting) forms of these medicines often are appropriately used as part of a safe and effective treatment regimen for patients in need. While in most cases the benefits to these patients are clear, there also exists the potential for abuse and diversion of these medicines in society at large.
Unfortunately, tampering with extended-release pain medications has become a serious public health concern. For our part, Cephalon is committed to doing all that we can to promote the safe and responsible use these products. Through our subsidiary, CIMA LABS INC., we are utilizing our considerable expertise in drug delivery technologies to develop tamper-deterrent formulations of long-acting opioids that are designed to reduce the risk of abuse. Specifically, we are seeking to develop formulations that address both the problem of crushing (which makes some extended release tablets act as immediate-release formulations) and alcohol “dumping” (where the absorption of the opioid is enhanced when ingested or mixed with alcohol).
While we work to develop commercial formulations of this technology, we also are taking comprehensive steps approved by the Food and Drug Administration (FDA) to minimize potential risks associated with abuse and diversion of our own opioid product, FENTORA® (fentanyl buccal tablet) [C-II], an immediate release product approved for the treatment of breakthrough cancer pain in opioid-tolerant patients. To date, there have been no reports of illicit tampering with FENTORA. We have implemented a FENTORA Risk Minimization Action Plan that is designed to enable us to quickly detect and effectively respond to instances of inappropriate use of FENTORA should they occur.