Everyone suddenly has an opinion on Fentora. Good opinion: The Cephalon painkiller got European approval a couple of weeks ago, after two years on the market in the U.S. Another good opinion, in the imitation-is-flattery department: Watson Pharmaceuticals filed for the FDA OK on its copycat version of the oral med. In good opinion number three, analysts pooh-poohed Watson's generic challenge, saying, "Fentora is a novel invention and the patents are strong."
Then there's one not-so-sure opinion, from none other than the FDA. As the anesthetic drug advisory committee prepares to discuss broadening usage of Fentora at next week's meeting, an agency staffer raised the twin specters of drug abuse and adverse events in briefing documents. Fentora's current risk-management programs have already failed in a few instances, the documents state, leading to serious adverse events, including overdose deaths. You'll recall that the company strengthened warnings on Fentora's label to help prevent those problems, which seem to stem from prescribing the med inappropriately and from substitution errors.
Given these problems, the documents say, expanding Fentora's indication beyond breakthrough cancer pain could lead to more misuse. And it could make the med more accessible to potential abusers. Key to approval, the staffer wrote, would be an effective risk management program. Is this possible? We'll see what the advisory committee says next week.