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# BIO Comments on Opioid Use Disorder Guidance
- URL: https://www.fdaweb.com/bio-comments-on-opioid-use-disorder-guidance/
- Published: 2018-10-10T12:00:00.000Z
- Updated: 2026-09-15T00:37:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142561

Biotechnology Innovation Organization (BIO) has [submitted comments](https://www.bio.org/letters-testimony-comments/bio-comments-fda-draft-guidance-opioid-use-disorder-endpoints?ref=fdaweb.com) to FDA on its draft guidance *Opioid Use Disorder (OUD): Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.* The group commended the agency for “recognizing the need and interest in expanding primary and secondary endpoints used in clinical trials for medications used to treat OUD, including outcome measures important to patients and their families, clinicians, and the public.”

BIO’s comments requested that FDA provide clarification on how it defines relapse to illicit opioid use. The group suggested using the terms “persistent relapse to illicit opioid use” and consider definitions used for clinical trials for medication assisted therapy, such as four consecutive weeks of any non-study use by urine toxicology or self-report, or seven consecutive days of self-reported use.

BIO also requested that FDA consider reductions in public resource utilization as other possible endpoints used to demonstrate effectiveness of drugs for medication assisted treatment. “Such reduction in public resource utilization may include reduction in emergency or hospital visits, use of child protective services, or incarcerations or arrests,” it said. “Furthermore, the FDA should consider using patient reported assessments of treatment effectiveness (i.e., whether the patient feels/perceives that they are in recovery as a result of medication assisted treatment use) as a potential patient-reported outcome to demonstrate effectiveness of medication assisted treatments.”

  
Additionally, BIO recommended that FDA provide additional detail about Phase 3 studies for medication assisted treatments, such as the duration of treatment in a study, similar to what is outlined in the agency’s *Guidance for Industry on Alcoholism: Developing Drugs for Treatment*. And, further information on the number of Phase 3 studies would be helpful, the group said.