Nasrat: “their concern is that this is instant release and it’s used as needed so if you take it when you need it and you just ate a lot of fat then it affects you”.
This exact same situation applies to any and all IR opioids, so the FDA should be consistent in their requirements for dealing with this T-max issue: either approve all IR opioid meds (whether ADF or non-ADF) with simple labeling instructions or withdraw approval from all of them.
It is well known that the majority of meds are affected in some way (eg faster or slower rate of absorption; greater or lesser amount of absorption) by interactions with various types of foods (eg fat, dairy, alcohol, grapefruit, as well as with other drugs the person may be taking).
There is no 100% perfect, universally applicable drug, that applies to 100% of situations instantly (i.e. regardless of other factors present in the patient’s body). That’s why easily understandable written directions are needed on the label and/or an insert: Take 1 hour before a meal or 2 hours after a meal. Do not take more than 2 pills within a 4-hour period”.
Similarly, there is no 100% absolutely abuse prevention drug in existence for the simple reason that someone can ingest a whole bottle of pills at one time. That’s why all types of ADF formulations are called “deterrents” (rather than “abuse proof”). BUT SOME ADF FORMULATIONS HAVE MORE EFFECTIVE DETERRENT PROPERTIES THAN OTHERS. SequestOx is one of the MOST EFFECTIVE. If FDA wants to save lives from abuse of opioids (intentional abuse or the more usual un-intentional abuse), they should approve SequestOx asap!
No doubt, Nasrat and our guy Eugene will solve this issue with the FDA and get it approved soon.
