be pursued during the meeting and a summation of the FDA’s standard for success when it comes to abuse-deterrent opioid formulations.
In order to qualify, the formulation must meet two standards. The first requires that, when used as labeled, the medication delivers a dose of the opioid that is effective and consistent. The second standard dictates that the drugs have properties that can significantly reduce the potential for abuse.
The paper also highlights where the FDA hopes the program will head in the future, eventually culminating in the availability of abuse-deterrent opioid formulations for all major opioids.
A spokesperson for the FDA declined a request for further comment on the upcoming meeting.