Het advies orgaan van de FDA heeft de fentanyl lolly tegen gehouden voor pijnen anders dan de oncologische pijnen. De reden: het aantal patienten dat er baat bij heeft is te klein en de kans op verslaving en misbruik is te groot. Volledig verslag staat hier onder.
(Bron: Elsevier global news)
Gaithersburg, Md. (EGMN) — A federal advisory panel has recommended against approval of the buccal formulation of the potent, rapidly acting opioid fentanyl for treating breakthrough pain in opioid-tolerant, non-cancer chronic pain patients
At a joint meeting of the Food and Drug Administrationâ€™s Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committee on May 6, the panel voted 17 to 3 to recommend against approval for this indication. Among the main concerns voiced by panelists was that expanding the approval of buccal fentanyl for what several panelists said was a relatively small patient population would markedly increase the amount of the drug available for diversion, misuse, and abuse.
Fentanyl buccal tablets, marketed by Cephalon Inc., as Fentora, were approved in 2006 for treating breakthrough pain in patients with cancer who are already on around-the-clock opioid therapy. Like Actiq, a fentanyl-containing lozenge on a stick, Fentora was approved with a risk management program in place designed to prevent abuse and misuse and accidental exposure to these products, particularly among children.
In September 2007, the FDA issued a public health advisory noting reports of serious adverse events â€“ including deaths â€“ connected to the product, due to improper patient selection and other factors. Those reports included cases of patients who were non-opioid tolerant and received Fentora; other cases were caused by improper dosing and substitution of Actiq for Fentora.
More than 80% of the prescriptions for buccal fentanyl tablets are for off-label use and there is evidence of abuse among patients, according to FDA presentations at the meeting. FDA officials referred to the high risk of intentional or potentially fatal overdoses, misuse, abuse, or diversion of buccal fentanyl tablets, which could have a significant impact on public health and safety.
The FDA usually follows the recommendations of its advisory panels, which are not binding.