This morning, in reading an article from the Pink Sheet written by Sarah Karlin-Smith, I flashed on my blog post from September 24, 2020 (here) discussing the new warning on benzodiazepine products. In this post, I had expressed concern that the abuse-deterrent formulation (ADF) craze of opioid formulations might be creeping in on other products of abuse. The Pink Sheet article (here, paid subscription required), titled “US FDA Has Soured On Abuse Deterrent Labeling Even Outside Of Opioids, Stimulant Docs Suggest,” goes into some detail relative to a proposed ADF of an immediate-release amphetamine sulfate capsule and describes how the FDA might be looking differently at ADFs, especially in light of the recent finding that even the ADFs of some of the opioids were not found to prevent or lower the abuse potential of these products.
The FDA’s argument centers around the preferred route of abuse for stimulant product, which it says is oral, and recognizes that the excipient used in the ADF products can cause safety problems if injected or inhaled through the nose. Perhaps the shine has worn off the entire ADF bandwagon and the Agency is now coming to the conclusion that the effort (which can’t be seen for years until after an ADF is marketed) may not be worth the reward, especially if the reward is not realized by the ADFs. As the Pink Sheet article states, “In September 2019, FDA sought public comments on whether abuse-deterrent formulations could play a public health role in the misuse and abuse of stimulants… Nearly 96% of those commenters expressed negativity towards the development of ADFs, the agency said.” Also see our previous post (here) on the FDA’s request for comments on stimulant drugs of abuse. Stay tuned for the next chapter in this continuing saga.