Endo's Belbuca Is First Buccal Film In Extended-Release Opioid Class
This article was originally published in The Pink Sheet Daily
While Belbuca represents a new formulation, it does not contain the abuse-deterrent properties that FDA has been encouraging.
You may also be interested in...
FDA wants to get a handle on how long-term use of long-acting pain killers relates to abuse and misuse; the agency also is requiring labeling changes that remove “moderate” pain from the products’ indication.
REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.
Dosing is capped under emergency use authorizations, but studies show reduced antibody response following primary vaccination series in individuals with compromised immune systems; although BLA approval could allow for off-label prescribing, government officials are exploring other regulatory options for earlier access, including through a study.