Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)

Completed

• Conditions: Baseline Epidemiologic Assessment
• Interventions: Drug: MorphaBond ER; Drug: Comparator Drug

• Registration Number: NCT04033094
• Lead Sponsor: Daiichi Sankyo

Brief Summary

The main objectives of this study are to provide surveillance/descriptive data to (a) assess utilization of MorphaBond ER and selected comparators overall and by age group and census regions using nationally-projected quarterly drug dispensing data and (b) assess the scope and pattern of abuse and clinical outcomes for MorphaBond ER using nationally representative data or data from large geographic areas in different populations.

Findings of this study will support the design of formal epidemiology assessment of the risks of addiction, overdose, and death outcomes associated with MorphaBond ER and appropriate comparators in the future.

Detailed Description

The study started after the launch of MorphaBond ER in October 2017 and will continue until September 2020 and the final study report will be submitted to the FDA by December 2020.

This is an observational study that will provide descriptive data on the utilization and abuse of MorphaBond ER and related outcomes (addiction, misuse, abuse, overdose, overdose-related deaths) for MorphaBond ER and selected comparators in response to the US-FDA's post-marketing requirement (PMR 2961-9 for MorphaBond ER).

No investigational products or pharmaceutical agents will be provided or administered for the purpose of this study. Multiple data sources, representing different populations and large geographic areas in the US, will be utilized to study the patterns of MorphaBond ER utilization and abuse and related outcomes.

The overall purpose of this study is to collect meaningful baseline data to support subsequent studies for formal epidemiologic assessment of abuse deterrence of MorphaBond ER as required by the FDA.

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17566

Inclusion Criteria

• Male or female
• MorphaBond ER users or relevant comparator users

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MorphaBond ER	MorphaBond ER	-
Comparator Group	Comparator Drug	-

Primary Outcome Measures

Name	Time	Method
Rates of addiction of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Overdose rates of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed	October 2017 through September 2020
Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Rates of misuse of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020

Secondary Outcome Measures

Name	Time	Method
Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).	October 2017 through September 2020

Trial Locations

Locations (1)

Daiichi Sankyo, Inc.; 🇺🇸 Basking Ridge, New Jersey, United States