Cephalon’s bid to get approval for expanded use of its cancer painkiller Fentora has hit a stumbling block after a US Food and Drug Administration panel voted against prescribing the treatment for a much wider indication.

The agency’s Joint Advisory Committee for Anaesthetic and Life Support Drugs and the Advisory Committee for Drug Safety and Risk Management voted 17–3 not to recommend approval of Fentora (fentanyl buccal) for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions. The drug is currently marketed in the USA to treat breakthrough pain in patients with cancer who are already taking opioids.

The panel is particularly concerned about minimising risks potentially associated with an expanded indication of Fentora, notably overdosing and death. Indeed last September, the FDA issued a public health advisory to warn about reports of adverse effects in patients taking the drug, noting that "deaths reported were the result of improper selection of patients, dosing, or improper product substitution." Making Fentora more widely available can only worsen misuse, the panel added.

The FDA panel noted that 80% of Fentora prescriptions are written for patients who are not suffering from cancer but this off-label is exactly the reason why Cephalon believes that an expanded approval would help to ensure that the drug could be used safely. During the meeting, the company presented what it calls “a comprehensive and novel risk minimisation action plan” to assure “appropriate patient selection and to mitigate the risks of overdose, abuse and diversion”.

The advisory committee said they were impressed with the plan which includes restricting the number of physicians who can prescribe Fentora and making sure that all shipments of the drug are connected to radio-frequency identification devices. However they want to see more data comparing Fentora worth other painkillers before any recommendations could be made.

Cephalon chief executive Frank Baldino said in a conference call that although the firm is disappointed, “we are not surprised”. He added that the expanded label is a "challenging subject" that comes at a "challenging time" for the agency and his firm will work with the FDA over the next few months to determine future steps to address the panel's concerns in a broader patient population.