FDA Seeking Hard-to-Abuse Painkillers
It's also considering how to evaluate such studies, as well as what claims to eventually allow on drug labels.
In the meantime, the FDA said it will take a "flexibile" approach to the evaluation and labeling of potentially abuse-deterrent drugs.
Prescription opioid analgesics -- painkillers such as oxycodone -- are an important component of modern pain management, the FDA says in a recently released "guidance" for the industry." It also notes that abuse and misuse of pain-killers has created a serious and growing public health problem.
The FDA wants to make pain-killers available to those who need them, and therefore it considers the development of abuse-resistant drugs to be a "high public health priority."
Current abuse-deterrent formulations are intended to prevent people from abusing pain medications, either by swallowing them whole, crushing and swallowing, crushing and snorting, crushing and smoking, or crushing, dissolving and injecting.
Abuse-deterrents generally fall into the following categories:
-- Physical/Chemical barriers can change the physical form of an oral drug, making it less easy to abuse by chewing, crushing, cutting, grating or grinding.
-- Agonist/Antagonist combinations can be added to a drug to reduce or defeat the euphoria associated with abuse. Some "antogonists" would be released only if the drug is improperly chewed, injected or otherwise manipulated.
-- Aversion: Substances can be combined to produce an unpleasant effect if too much medication is ingested or injected.
-- Delivery system: Certain drug release designs or the method of drug delivery can offer resistance to abuse. Shots and implants, for example, can be more difficult to manipulate.
-- Some drugs can be delivered in inactive form, transformed only when they reach the gastrointestinal tract.
The FDA says two or more of the above methods can be combined to deter abuse.
The FDA guidance says studies designed to evaluate the abuse-deterrent characteristics of pain-killers should be "scientifically rigorous," and take into consideration the most common way the drug is abused.