BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.
The draft guidance is an important step in clarifying the FDA’s view of endpoints to demonstrate efficacy of therapies to treat opioid use disorder (OUD). It’s important to expand primary and secondary endpoints in clinical trials for medications to treat opioid use disorder, including the outcomes patients and clinicians said were important to them at the public meeting on patient-focused drug development for opioid use disorder.
BIO requests clarification on how the FDA defines relapse to illicit opioid use, and requests FDA consider other possible endpoints to demonstrate effectiveness of drugs. BIO recommends the FDA provide additional detail on Phase III studies for medication assisted treatments.