FDA panel rebuffs Fentora sNDA

At a joint meeting, FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees voted 17-3 on Tuesday not to recommend approval of Fentora fentanyl buccal tablets from Cephalon (NASDAQ:CEPH) to manage breakthrough pain in opioid-tolerant non-cancer patients with chronic pain. Acting panel Chairman Sulpicio Soriano, summarizing the sentiment of the committee, said the population that would benefit from Fentora is relatively small, and the safety risks and abuse potential remain high. Last year, FDA and Cephalon issued warnings in response to serious adverse events, including deaths in patients who were not appropriate candidates for the fast-dissolving transmucosal formulation of fentanyl.

Some panel members suggested the RiskMAP Cephalon proposed in support of the sNDA should be implemented for the current indication to show it works before they would recommend broadening the indication. The RiskMAP was designed to minimize overdose, abuse and diversion by requiring database registration of the physician, pharmacist, and patient before a Fentora prescription could be dispensed. Fentora is approved to manage breakthrough cancer pain in patients who are tolerant to opioid therapy. The PDUFA date for the sNDA is Sept. 13. Trading in shares of Cephalon was halted on Tuesday. On Monday, the stock closed at $60.16. ...